Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Karantana, 2020

(individual study characteristics deduced from Karantana, 2020)

PS., study characteristics and results are extracted from the SR (unless stated with *)

SR and meta-analysis of (quasi)-RCTs

Literature search up to June 2019

A: Azzopardi, 2005

B: Rodriguez-Merchan, 1997

C: Stoffelen, 1998

D: Wong, 2010

Study design: RCT

Setting and Country:

School of Medicine /University setting, UK

Source of funding and conflicts of interest:

Internal sources:

Teesside University, University of Nottingham & University of Manchester, UK.

External sources

National Institute for Health Research (NIHR) via Cochrane Infrastructure funding to the Cochrane Bone, Joint and Muscle Trauma Group, UK.

Inclusion criteria SR:

(quasi) randomized controlled trials of percutaneous pinning (PP) for treating distal radial fractures in adults (completed skeletal growth)

Exclusion criteria SR:

• comparing PP with other methods of surgical fixation, trials;
• evaluating the use of supplementary PP in addition to another method of surgical fixation;
• surgical versus. non-surgical treatment trials where the type of surgery was chosen by the surgeon, where PP was one of different surgical fixation methods used;
• trials on pin site maintenance or other measures to prevent wound infection

A total of 21 (quasi) RCTs was included in the review. 4 studies on PP versus. immobilization that were a (quasi-) RCT and had a full publication (no abstract only) were used in the current analysis

Important patient characteristics at baseline:

N, age (mean (range))

A: N=57 (I:30, C:27)

 71.5y (60-80)

B: N=40 (I:20, C:20)

 57 (46-65)

C: N=98 (I:48, C:50)

 58y

D: N=62 (I:32, C:30)

 70.5y (65-76)

Sex, n/N (%) male:

A: 6/54 (11%)

B: 11/40 (27%)

C: 57/98 (58%)

D: 11/60 (18%)

Groups comparable at baseline?

Surgical: percutaneous pinning (PP)

A: PP: using 2 crossed, smooth K-wires, 1.6 mm diameter, inserted through small stab incisions under fluoroscopic guidance. 1 wire through the styloid process, the other through Lister's tubercle or the dorso-ulnar border of distal fragment. Both wires engaging opposite cortex. Blunt dissection to bone. Pins left protruding percutaneously. Wrist immobilised in "well-moulded" short-arm cast. Wires/plaster removed after 5 weeks

B: Closed reduction under general anaesthesia or brachial block. PP with fluoroscopic assistance using 3 K-wires. Two 0.45 mm K-wires inserted from radial styloid proximally towards the ulna and one inserted from the ulnar side proximally towards the radius. Forearm cast applied. Pins and cast removed after 7 weeks

C: Percutaneous triple intrafocal Kapandji pinning (distal fragment was not transfixed; pins acted as a

buttress to articular surface) followed by 1 week of plaster immobilisation until pain subsided. (By deduction: pins in place for 6 weeks)

D: K-wire insertion was probably percutaneous. Pins inserted under general or regional anaesthesia. Reduction was done during the operation. Operation done under Bier's block; with the distal radius in reduced position, then insertion of 3 K-wires (percutaneous) under fluoroscopic guidance through three small stab incisions ("tripod" construct described in report); wires were not buried; no plaster of Paris was applied to augment the fracture stability but the occupational therapist made a removable palmar splint for resting purpose. Immediate gentle mobilisation under instructions of a physiotherapist was allowed. Wires were removed after fracture consolidation.

Conservative: immobilization

A: Three-point fixation obtained in a "well-moulded" short-arm cast for 5 weeks.

B: Closed manipulation under local anaesthesia, split below-elbow cast (20 degrees palmar flexion, 10

degrees ulnar deviation) (remanipulation at 1 week if dorsal angulation > 10 degrees, radial shortening

> 3 mm. New cast applied). Patients given instructions to mobilise their fingers. Cast removed after 7 weeks.

C: Closed reduction, followed by an above-elbow plaster cast for 3 weeks, then below-elbow plaster cast for 3 weeks

D: Cast group: closed reduction under haematoma block, Jones's methods used for reduction, below-

elbow plaster of Paris was applied.

End-point of follow-up:

A: 12M

B: 12M

C: 12M

D: 19.5M (13-24)

For how many participants were no complete outcome data available?

(intervention/control)

A: 9 (unclear)

B: 0

C: 0

D: 2 (2/0)

Function

Defined as Mayo Wrist score (0-100; reflects pain, grip strength, range of motion, and return to employment; higher is better);

mean±sd

A: NR

B: NR

C: NR

D: I: 82.2±6.2

C: 80.5±7.5

Defined as ROM (°); mean±SD

A: NR

B: NR

C: NR

D: Flexion

I: 73.0±8.2

C: 72.0±10.0

Extension

I: 72.0±7.0

C:71.0±8.0

Radial deviation

I: 21.0±6.0

C:24.0±7.0

Ulnar deviation

I: 20.0±6.0

C:21.0±7.0

Supination

I: 76.0±4.0

C:75.0±7.0

Pronation

I: 77.0±4.0

C:75.0±7.0

Pain

Defined as ‘yes’ occasional pain

A: NR

B: I: 2/20, C: 4/20

C: NR

D: NR

Complications

Secondary treatment

A: I: 0/27, C: 1/27

B: I: 0/20, C: 15/20

C: NR

D: NR

Infection

A: I: 1/27, C: 0/27

B: I: 2/20, C: 0/20

C: NR

D: I: 1/30, C: 0/30

Tendon injury/rupture

A: I: 0/27, C: 0/27

B: I: 0/20, C: 0/20

C: NR

D: NR

Nerve injury (also CTS)

A: I: 0/27, C: 0/27

B: I: 0/20, C: 1/20

C: I: 6/48, C: 2/50

D: NR

Complex regional pain syndrome

A: NR

B: I: 1/20, C: 1/20

C: I: 12/48, C: 15/50

D: I: 0/30, C: 1/30

Cochrane review; good quality publication

Authors conclusion:

Overall, there is insufficient RCT evidence to inform on the role of percutaneous pinning versus cast immobilisation alone

Risk of Bias:

A: randomized by tossing coin, concealment not described; participants and personnel not blinded; assessors not blind; intention-to-treat (ITT) analysis claimed but 6/9 lost to follow up not identified; protocol available, small differences; participants balance but 3 deaths (pinning group) not included

B: randomized using blinded consecutively numbered envelopes, sequence generation and allocation concealment unclear; participants and personnel not blinded; ITT: likely; loss to follow-up: none, probably; selective reporting unclear, no protocol available and results are incomplete and inadequate

C: quasi-randomized: patients were alternately treated: possible selection bias; participants and personnel not blinded; no participants flow available, imbalance in groups (50 versus. 47); no protocol available, incomplete data (no SDs), imbalance gender + number of participants with high velocity injuries.

D: randomization method not described, but patients randomly allocated by opening sequentially numbered opaque sealed envelopes; participants and personnel providing intervention not blinded, assessors blinded; personnel assessing complications probably not blinded; ITT analysis and no loss to follow-up, 2 death from heart disease unrelated to intervention; no protocol available, but outcomes reported in methods are adequately reported; participants balanced at baseline

Handoll, 2007

(individual study characteristics deduced from (Handoll, 2020)

PS., study characteristics and results are extracted from the SR (unless stated with *)

SR and meta-analysis of (quasi-) RCTs

Literature search up to September 2006

A: Abbaszadegan, 1990

B: Hegeman, 2004

C: Horne, 1990

D: Kapoor, 2000

E: Kreder, 2006

F: Lagerstrom, 1999

G: McQueen, 1996

H: Rodriguez- Merchan, 1992

I: Stein, 1990

J: Young, 2003

K: Zheng, 2003

Study design: (quasi-)RCT

Setting and Country:

Centre for Rehabilitation Sciences, University of Teesside; Royal Infirmary of Edinburgh; Cochrane Bone, Joint and Muscle Trauma Group, University of Manchester. UK

Source of funding and conflicts of interest:

Internal sources: University of Teesside, UK.

External sources:

• No sources of support supplied

Inclusion criteria SR:

(quasi) randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared external fixation with conservative treatment.

Exclusion criteria SR:

Trials with a mixed population

of adults and children, with proportion children >5% and no separate data for adults.

We excluded trials comparing different methods, including techniques

and devices, of external fixation; or trials comparing external

fixation with other methods of surgical fixation, such as percutaneous

pinning, or trials evaluating the use of supplementary

methods, such as bone grafts and substitutes, other than percutaneous

pinning, to external fixation compared with conservative

treatment.

A total of 15 (quasi) RCTs was included in the review. 11 studies on PP versus. immobilization that were a (quasi-) RCT and had a full publication (no abstract only) were used in the current analysis

Important patient characteristics at baseline:

N, mean age

A: N=47 (I:23, C:24)

 63y (22-75)

B: N=32 (I:15, C:17)

 70y (55-80)

C: N=37 (at least I:15,

C:16 or I:14, C:13)

 Of analyzed n=29: 72y

 (61-91)

D: N=61 (I:28, C:33)

 39y (of 3 study arms)

E: N=113 (I:54, C:59)

 53y

F: N=35 (I:18, C:17)

 58y (45-72)

G: N=90 (I: 60 (two study

 arms), C: 30)

 63y (16-86) (of N=120)

H: N=70 (I:35, C:35)

 36y (20-45)

I: N=62 (I: 40, C: 22)

 50y (19-79)

J: N=125 (I:59, C:66)

 57y (16-75)

K: N=29 (I:12, C:17)

 - (18-52)

Sex, n/N (%) male:

A: 11/47 (23%)

B: 3/32 (9%)

C: not stated

D: 46/61 (75%)

E: 74/113 (35%)

F: 5/35 (14%)

G: 9/90 (10%)

H: 58/70 (83%)

I: not stated

J: 28/125 (22%)

K: 15/29 (52%)

Surgical: external fixation (EF)

A: closed reduction under local anaesthesia, temporary dorsal plaster cast. External Hoffman fixator applied at 1-3 days under regional anaesthesia: 2 pins inserted through 1 cm skin incision through middle of second metacarpal and 2 pins in radius. Fixator removed at 4w (mean 31d)

B: reduction then application of Hoffmann II compact external fixator: 2 pins inserted into the second metacarpal and 2 pins in radial shaft. Fixator removed after 6 weeks

C: closed reduction under ischaemic arm block then modified AO tubular external

fixator for 5 weeks: 2 pins placed at right angles in 2nd metacarpal, 2 pins placed at right angles into dorsoradial aspect of distal radius. “Stab incisions” of pins.

D: Roger and Anderson external frame fixator: 2 pins into 2nd and 3rd metacarpals, 2 into radius shaft. Patients encouraged to use limb (eating etc) and rotate forearm. Fixator removed 6-7 weeks. Splint for 2 days after removal of fixator, then mobilisation.

E: closed reduction under regional anaesthesia. Application of small spanning AO fixator: 2.5 mm pins into 2nd metacarpal and 4 mm pins into radius via 1 cm skin incision. Additional (in 19 cases) smooth K-wires inserted from the radial styloid or dorsum of the radius across fracture fragments at surgeon’s discretion. Optional wires removed 4-6 weeks. Fixator removed at 6-8 weeks.

F: light (in weight) non-cylindrical AO external fixator. Immobilised for 6 weeks.

G: (1) closed reduction and Pennig external fixator. Two pins inserted into 2nd metacarpal and 2 into radial shaft using an open technique. Ball joint locked. Fixator removed after 6 weeks. (2) as above (1) but release of ball joint of fixator at 3 weeks to allow wrist movement.

H: reduction under general anaesthesia or brachial block. Clyburn dynamic external fixator: 2 pins driven into radial diaphysis and 2 into diaphysis of 2nd metacarpal. Overnight hospital admission. Posterior splint applied for 3 weeks if joint disrupted; transverse pin inserted for 3 weeks if

joint unstable. Device removed after 7 weeks. Pin sites dressed by medical staff at weekly intervals

I: closed reduction then the “small” AO external tubular fixator, usually for 6 weeks:

2 pins placed in 2nd metacarpal, 2 pins placed into radial shaft.

J: manipulation and application of bridging Pennig dynamic fixator under general anaesthesia. Pins inserted percutaneously into 2nd metacarpal and under direct vision into the radial shaft. Distal ball joint unlocked at 3 weeks, fixator removed at 6 weeks

K: closed (5 participants) or open (7 participants) reduction under brachial plexus block. Then application of small size Zhongjia SGD-type unilateral multifunctional external fixator: 2 pins inserted through skin incisions (0.7 cm) into the second metacarpal and 2 pins through skin incisions in radial shaft. Kirschner wire added if fracture was still unstable. Wrist fixed in medial position, slight extension and ulnar deviation or volar flexion (opposite to the direction of the injury). Fixator made dynamic and K-wire removed from week 4. Fixator removed after 6 weeks. Immediate functional

training finger mobilisation; then, finger, elbow and shoulder from week 2; wrist joint mobilisation and

strengthening activities from week 4.

Conservative: immobilization

A: Closed manipulation under local anaesthesia, then below elbow plaster cast for 4 weeks (mean 31 days)

B: closed manipulation then below elbow plaster cast for 6 weeks. Physiotherapy started after 6 weeks.

C: closed reduction under ischaemic arm block then below-elbow backslab, 10-

15 degrees palmar flexion and ulnar deviation, for 5 weeks

D: closed reduction and plaster cast. Remanipulated once if necessary. Immobilisation for 6 to 7 weeks

E: closed reduction under haematoma block (and fluoroscopy), then long arm

splint with wrist in neutral and elbow at 90 degrees - reduction repeated if necessary. Splint converted to long arm cast within 14 days, reduced to short arm cast at 3-4 weeks, removed at 6-8 weeks.

F: cylindrical below elbow plaster cast for 6 weeks.

G: closed manipulation, then forearm cast for 6 weeks

H: closed manipulation under local anaesthesia, then forearm plaster. Remanipulation at 1 week if position unacceptable. Total 7 weeks, unless problems when kept for 1 more week.

I: closed reduction then above-elbow plaster cast with the forearm in pronation, usually for 6 weeks

J: manipulation under regional or general anaesthesia and application of below elbow plaster backslab; then completed to full below-elbow plaster cast at 1 week and removed at 6 weeks

K: manual reduction under haematoma block with X-ray monitoring. Plaster of

Paris short-arm (forearm) cast applied, position changed after 2 weeks to “medial”. Cast removed after 6 weeks. Functional training was done before and after removing the cast.

End-point of follow-up:

A: 12M

B: 12M

C: 4-15M

D: 48M

E: 24M

F: 12M, 24M

G: 12M

H: 12M

I: 6M-48M (mean 36M)

J: 12M, 84M

K: 12M

For how many participants were no complete outcome data available?

(n/N interv, n/N contr)

A: 1/23, 0/24

B: 0/15, 0/17

C: not reported

D: 18/28, 23/33

E: 10/54, 18/59

F: 2/18, 2/17

G: 6/60, 2/30

H: 0/35, 0/35

I: 0/40, 0/22

J: 48/59, 60/66 at 12M

23/59, 16/66 at 84M

K: 0/12, 0/17

Function

Defined as ROM

A: NR

B:

at 1 year, % compared to uninjured side; mean (SD)

Flexion: I: 89 (19), C: 89 (17)

Extension: I: 88 (20), C: 72 (21)

C: NR

D: NR

E:

at 2 years; difference injured – normal side; degrees mean (SD)

Flexion: I: -8.9(8.3), C: -14.5(15.2)

Extensio: I: -4.6 (8.9), C: -6.2 (7.1)

Radial dev: I: 0 (5.9), C: 3.5 (8.8)

Ulnar dev: I: -3 (6.6), C: -6 (12.4)

Supinat: I: -7.5 (14.2), C: -1.1 (13.9)

Pronation: I: -4.6(20.5), C: -3.9 (7.8)

F: NR

G: at 1 year, % of normal side, mean (SD)

Flexion/extension:

I: 86.56 (11.65), C: 83 (14)

Overall ROM:

I: 89 (13), C: 93 (11)

H: NR

I: NR

J: at 1 year, degrees, mean (SD)

Flexion: I: 63(5.3), C: 61(5.8)

Extensio: I: 60(5.7), C: 60 (7.1)

Radial dev: I: 21(3.1), C: 22(4.3)

Ulnar dev: I: 36(4), C: 33(5)

Supinat: I: 87(5), C: 86(4)

Pronation: I: 90(0.6), C: 88(0.2)

K: NR

Pain

Defined as ‘yes’ persistent pain

A: NR

B: at 1 year

Radiocarpal pain: I: 2/15, C: 3/17

Ulnocarpal pain: I: 2/15, C: 3/17

Radioulnar pain: I: 2/15, C: 3/17

C: NR

D: NR

E: NR

F: NR

G: NR

H: NR

I: NR

J: at 1 year: I: 5/48, C: 4/60

at 7 years: I: 6/36, C: 11/50

K: NR

Secondary treatment

A: Redisplacement resulting in secondary treatment:

I: 0/23, C: 5/24

B: NR

C: Redisplacement resulting in secondary treatment:

I: 0/17, C: 0/17

D: NR

E: Redisplacement resulting in secondary treatment:

I: 1/54, C: 5/59

F: Redisplacement resulting in secondary treatment:

I: 0/18, C: 5/17

G: NR

H: NR

I: Redisplacement resulting in secondary treatment:

I: 0/40, C: 11/22

J: Redisplacement resulting in secondary treatment:

I: 3/59, C: 3/66

K: NR

Complications

Defined as infection

(here: pin track infection)

A: (+osteomyelitis 0/0)

I: 3/23, C: 0/24

B: I: 2/15, C: 0/17

C: NR

D: I: 1/28, C: 0/33

E: I: 6/54, C: 1/59

F: NR

G:(+wound infection 0/0)

I: 9/60, C: 0/30

H: (+osteomyelitis 0/0)

I: 4/35, C: 0/35

I: (+osteomyelitis 0/0)

I: 2/40, C: 0/22

J: I: 14/59, C: 0/66

K: NR

Defined as Tendon injury/rupture

A: NR

B: NR

C: NR

D: NR

E: NR

F: NR

G: I: 0/60, C: 0/30

H: I: 0/35, C: 0/35

I: NR

J: at 7 years, I: 0/36, C: 2/50

K: NR

Defined as Nerve injury

A: Superficial radial nerve paraesthesia or injury

I: 1/23, C: 0/24

B: NR

C: Radial nerve neuritis or neuropathy

I: 4/15, C: 0/14

D: Median nerve compression /CTS

I: 0/28, C: 1/33

E: NR

F: NR

G: Median nerve compression /CTS

I: 3/60, C: 1/30

H: NR

I: Superficial radial nerve paraesthesia or injury

I: 3/40, C: 0/22

J: Median nerve compression /CTS + Radial nerve neuritis or neuropathy

I: 12/59, C: 8/66

K: Median nerve compression /CTS + Superficial radial nerve paraesthesia or injury

I: 1/12, C: 3/17

Defined as Complex regional pain syndrome (also: reflex symp dystrophy)

A: NR

B: I: 4/15, C: 1/17

C: I: 0/15, C: 0/14

D: I: 1/28, C: 0/33

E: I: 1/54, C: 2/59

F: NR

G: I: 7/60, C: 1/30

H: I: 0/35, C: 2/35

I: I: 1/40, C: 0/22

J: I: 7/59, C: 7/66

K: NR

Cochrane review; good quality publication

Authors conclusion:

There is some evidence to support the use of EF for dorsally displaced fractures of the distal radius in adults.

Though there is insufficient evidence to confirm a better functional outcome, EF reduces redisplacement, gives improved anatomical

results and most of the excess surgically-related complications are minor.

Risk of Bias, based on allocation concealment:

A: unclear risk

B: unclear risk

C: unclear risk

D: unclear risk

E: low risk

F: unclear risk

G: unclear risk

H: unclear risk

I: high risk

J: unclear risk

K: high risk

Study

First author, year

Appropriate and clearly focused question?

Yes/no/unclear

Comprehensive and systematic literature search?

Yes/no/unclear

Description of included and excluded studies?

Yes/no/unclear

Description of relevant characteristics of included studies?

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?

Yes/no/unclear/not applicable

Assessment of scientific quality of included studies?

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?

Yes/no/unclear

Potential risk of publication bias taken into account?

Yes/no/unclear

Potential conflicts of interest reported?

Yes/no/unclear

Karantana, 2020

Yes

Yes

Yes

Yes

n.a.

Yes

Yes

unclear

Yes, reported: no declarations of interest

Handoll, 2007

Yes

Yes

Yes

Yes

n.a.

Yes

Yes

No, “There were insufficient data to assess publication bias; for example, by preparing a funnel plot.”

Yes, reported: no declarations of interest

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Mulders,

2019

Type of study:

RCT

Setting and country:

Emergency Department of the Academic

Medical Centre Amsterdam or one of the other participating hospitals.

In total, 14 hospitals participated.

Funding and conflicts of interest:

The authors declare that they have no competing interests. No external funding was received for this study.

Inclusion criteria:

• Patients ≥ 18 years and ≤ 75 years
• Extra-articular (AO type A) displaced distal radius fracture, as classified on lateral, posterior-anterior and lateral carpo-radial radiographs by a radiologist or trauma surgeon.

• Acceptable closed reduction obtained according to Dutch guidelines a) <15° dorsal or <20° volar angulation of the distal; b) fracture fragment <5 mm loss of radial height

c) ≥15° radial inclination

Exclusion criteria:

• Open distal radius fractures
• Multiple trauma patients (Injury Severity Score (ISS) ≥16)
• Other fractures of the affected extremity
• Patients who indicate to have had impaired wrist function prior to injury, e.g. due to rheumatoid arthritis
• Patients suffering from disorders of bone metabolism known to adversely affect fracture healing
• Patients suffering from connective tissue or (joint) hyperflexibility disorders known to adversely affect fracture healing and/or soft tissue and wound healing.
• Patients unable to understand the treatment information /informed consent forms as judged by the attending physician

N total at baseline:

Allocated:

Intervention: 48

Control: 44

(1 in both groups withdrawn consent)

Treated: Intervention: 47

Control: 43

Age, median (IQR):

I: 59 (42-66)

C: 60 (52-65)

Sex, n/N, (%) male:

I: 16/47 (34%)

C: 7/43, (16%)

Baseline characteristics well balanced, except for % of patients with fracture of ulnar styloid process: more in control treatment.

Intervention:

Open reduction and internal fixation with a volar locking plate

All patients were initially treated with closed freduction and cast immobilisation.

Vitamin C 500 milligrams was prescribed at initial presentation and for a duration of 2 months in order to prevent Complex Regional Pain Syndrome.

The surgery will be performed by a general, trauma or orthopaedic surgeon. Antibiotic prophylaxis administered pre-operatively. The distal radius was approached according to Henry: an

incision between the tendon of the flexor carpi radialis and the radial artery. Then, the fracture was reduced and

provisionally fixed with K-Wires and/or reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type was selected. Screw placement and fracture reduction was confirmed

intra operatively by radiographic images. Wound closure was performed at the discretion of the surgeon using

standard techniques and no post-operative fixation or immobilisation will be applied.

Wound inspection during the first follow up visit at five to ten days.

Patients were instructed to use the affected extremity in daily activities as pain allowed.

At 1 week and 3 weeks: radiographs were performed in both groups to ensure that loss of reduction had not occurred. In case of loss of reduction, operative treatment was offered.

Comparison treatment: plaster immobilization

All patients were initially treated with closed reduction and cast immobilisation.

Vitamin C 500 milligrams was prescribed at initial presentation and for a duration of 2 months in order to prevent Complex Regional Pain Syndrome.

Continuation of treatment with cast immobilisation according to Dutch guidelines: a circular

cast for another four weeks.

At 1 week and 3 weeks: radiographs were performed in both groups to ensure that loss of reduction had not occurred. In case of loss of reduction, operative treatment was offered.

Length of follow-up:

12 months

Loss-to-follow-up:

Intervention: n = 1/47 (2%)

Reason unclear

Control: n = 3/43 (7%)

Reasons unclear

Incomplete outcome data:

Of all randomized patients, 96% had a complete 12-month follow up for primary outcome (DASH)

Function

defined as DASH score;

0 to 100, with 0 indicating no disability; median (IQR);

6 weeks

I: 22.5 (14.2 – 35.8)

C: 48.3 (35.6 – 57.7)

P<0.001

3 months

I: 6.7 (2.5 – 18.3)

C: 27.5 (10.0 – 38.3)

P<0.001

6 months

I: 5.8 (0.0 – 17.5)

C: 14.2 (7.9 – 29.6)

P=0.004

12 months

I: 2.5 (0.0–12.7)

C: 9.2 (1.7–17.7)

P=0.018

defined as PRWE score,

range, 0 to 100, with 0 indicating asymptomatic patient); median (IQR)

6 weeks

I: 29.0 (18.5 – 48.5)

C: 55.8 (40.9 – 70.9)

P<0.001

3 months

I: 11.0 (4.0- 2 2.5)

C: 32.5 (12.0 – 50.0)

P<0.001

6 months

I: 7.0 (3.0 – 29.0)

C: 20.0 (7.5 – 45.8)

P=0.008

12 months

I: 4.0 (0.0–12.6)

C: 10.0 (3.0–27.0)

P=0.015

defined as SF-36 score;

including physical and mental subscale, ranges from 0 to 100, with higher score indicating better state of health,

scores not specified

SF-36 physical component

I > C, p <.001

SF-36 mental component

no differences

defined as range of motion;

in °; median (IQR), % of uninjured side

Radial deviation

I: 15 (10-20) (97%)

C: 15 (10-15) (101%)

No difference

Ulnar deviation

I: 25 (25-31) (97%)

C: 25 (20-30) (94%)

No difference

Pronation

I: 90 (80-90) (99%)

C: 85 (75-90) (95%)

No difference

Supination

I: 85 (75-90) (97%)

C: 75 (70-85) (91%)

p<0.001

Extension

I: 85 (80-90) (98%)

C: 80 (70-90) (93%)

p=0.001

Flexion

I: 80 (70-86) (95%)

C: 70 (60-80) (89%)

p<0.001

Complications

Secondary treatment

I: 0/47, C: 18/43

(open reduct internal fix, n=12, corrective osteotomy, n=6)

Implant removal

I: 9/47, C: 1/43

Infection

Superficial wound infection

I: 3/47, C: 1/43

Tendinitis

I: 2/47, C: 2/43

Tendon injury/rupture

de Quervain tenosynovitis

I: 0/47, C: 2/43

EPL rupture

I: 3/47, C: 1/43

Nerve injury (also CTS)

CTS

I: 0/47, C: 3/43

Complex regional pain syndrome (CRPS)

CRPS type 1

I: 1/47, C: 4/43

Saving, 2019

Type of study:

RCT, combining two separate studies.

As results are described separately, we included the two sub studies separately.

Sub study I: Sodersjukhuset (Söd) Hospital

Sub study II: Danderyd (Dand) Hospital

Setting and country: two level-II trauma centers in Sweden.

Funding and conflicts of interest:

grants from the Swedish Research Council and the Regional Agreement on

Medical Training and Clinical Research between the Stockholm County Council and Karolinska Institute; grant from the °Ake Wiberg Foundation.

Inclusion criteria:

• Patient age ≥75 y (since Sept 2015, ≥70y at Söd. Hospital)
• Wrist radiograph of ≥20° dorsal tilt (and/or ≥4 mm axial shortening at Dand. Hospital)

Exclusion criteria:

• Former disability of either wrist
• Intra-articular fractures with a step-off of >1 mm or a gap of > 1 mm (at Söd. Hospital)
• High-energy trauma (Söd.Hospital)
• Associated ulnar fracture
• Injury to ipsilateral upper extremity
• Rheumatoid arthritis / other severe joint disorder
• Dementia or Pfeiffer score of <5 at Söd. Hospital and <8 at Dand. Hospital
• Drug or alcohol abuse or psychiatric disorder
• Dependency in activities of daily living
• Patient not a resident within the catchment area of the 2 centers
• Fracture diagnosed >3 days from injury at Söd. Hospital and >6 days at Dand. Hospital
• Patient not fit for surgery or American Society of

Anaesthesiologists class 4

N total at baseline: 140

Intervention: 68

Control: 72

Age median, range:

I: 80 (70-90)

C: 78 (70-98)

p=.388

Sex, n/N (%) male:

I: 3/58 (5%)

C: 8/64 (12%)

p=.211

Groups comparable at baseline.

Intervention:

Open reduction and internal fixation with a volar locking plate

Within 7 days after closed reduction and immobilization in a dorsal or dorsoradial short-arm plaster splint in the

emergency room.

A surgical procedure

with a volar locking plate was performed within 14 days from the fracture date with standard Henry approach under fluoroscopic control.

I: Söd. Hospital, 2.4-mm Variable Angle LCP Two-Column Volar Distal Radius Plate (DePuy Synthes) or a DVR plate (ZimmerBiomet); not listed in study registry data, but was introduced at clinic during study period.

II: Dand. Hospital: Acu-Loc plate (Acumed) or a Königsee plate (Swemac)

The wrist was immobilized in a dorsal plaster splint for 2 weeks postoperatively.

Thereafter, patients were referred to an occupational therapist.

Comparison treatment: plaster immobilization

Within 7 days after closed reduction and immobilization in a dorsal or dorsoradial short-arm plaster splint in the

emergency room.

The plaster splint from the emergency department was maintained for 4 to 5 weeks.

Thereafter, patients were referred to an occupational therapist.

Length of follow-up:

12 months

Loss-to-follow-up at 12 months, n/N (%):

Intervention: 12/68 (18%)

Reasons: withdrew consent (n=10), other medical reason (n=1), died (n=1)

Control: 9/72 (13%)

Reasons: withdrew consent (n=4), study paused (n=2), dementia (n=2), other medical condition (n=1)

Incomplete outcome data:

Not specified

Function

Sub-study I

N: I:34, C:34

defined as DASH score;

0 to 100, with 0 indicating no disability; mean (SD);

3 months

I: 23.7 (20.0)

C: 31.3 (19.4)

P=0.093

12 months

I: 18.7 (18.0)

C: 24.3 (20.1)

p=0.297

defined as PRWE score; range, 0 to 100, with 0 indicating asymptomatic patient); mean (SD)

3 months

I: 21.3 (20.8)

C: 34.2 (21.6)

P=0.012

12 months

I: 15.6 (16.3)

C: 23.4 (22.7)

p=0.217

defined as range of motion;

in °; mean (SD);

Extension

I: 52 (7)

C: 53 (9)

P=0.440

Flexion

I: 68 (11)

C: 54 (16)

P=<0.001

Supination

I: 105 (13)

C: 101 (15)

P=0.540

Pronation

I: 87 (8)

C: 85 (9)

P=0.284

Ulnar deviation

I: 28 (5)

C: 26 (5)

P=0.172

Radial deviation

I: 23 (3)

C: 24 (5)

P=0.265

Sub-study II

N: I:29, C:22

defined as DASH score;

0 to 100, with 0 indicating no disability; mean (SD);

3 months

I: 14.4 (16.0)

C: 26.6 (19.2)

P=0.088

12 months

I: 10.8 (14.6)

C: 21.7 (19.8)

p=0.018

defined as PRWE score, mean (SD)

3 months

I: 18.5 (19.5)

C: 34.1 (21.3)

P=0.088

12 months

I: 8.1 (11.6)

C: 21.3 (20.0)

p=0.012

defined as EQ-5D score;

I: 0.814 (0.226)

C: 0.801 (0.174)

p=0.488

defined as range of motion;

in °; mean (SD);

Extension

I: 61 (13)

C: 60 (14)

P=0.991

Flexion

I: 56 (12)

C: 48 (12)

P=0.022

Supination

I: 83 (8)

C: 79 (10)

P=0.162

Pronation

I: 82 (11)

C: 80 (11)

P=0.308

Ulnar deviation

I: 34 (16)

C: 26 (12)

P=0.071

Radial deviation

I: 21 (5)

C: 22 (8)

P=0.525

Sirnio, 2010

Type of study:

RCT

Setting and country:

Oulu University Hospital, Finland.

Funding and conflicts of interest:

no financial support was received, no potential conflicts of interest were reported.

Inclusion criteria:

• Displaced DRF (AO/OTA 23 type A2/A3 and C1/C2)
• Duration of < 1 week from primary injury
• Acceptable closed reduction achieved:

– dorsal angulation ≤ 10°

– radial inclination ≥ 15°

– ulnar variance < –3 mm

– articular step-off ≤ 2 mm

Exclusion criteria:

• Patients < 50 years old
• Acceptable closed reduction not achieved

(see inclusion criteria)

• Bilateral/open fractures
• Fractures with neurovasc. compromise
• Previous ipsilateral DRF
• Inflammatory joint disease
• Radiocarpal joint degeneration
• Limited cooperation or major comorbidity not allowing to operate
• Major concomitant fracture necessitating any operation

N total at baseline:

Intervention: 38

Control: 42

Age, mean (range):

I: 62 (50-79)

C: 64 (50-82)

Sex, n/N (%) male:

I: 1/38 (3%)

C: 3/42 (7%)

Groups comparable at baseline.

Intervention:

Open reduction and internal fixation with a palmar locking plate

Wrist was immobilized with a short-arm cast at the emergency unit.

Within 1 week after injury, patients underwent palmar plating of DRF applying a standard surgical technique. The distal part of the radius was exposed using a modified Henry’s approach.

Fracture reduction was achieved by open manipulation, and the fracture was stabilized using a palmar fixed-angle plate (Aculoc or Aculoc 2; Acumed, Hillsboro, OR, USA) with proximal 3.5-mm locking screws and distal 2.3-mm locking cortical pegs.

A dorsal plaster cast for pain relief was applied

for 10 days, after which the patients received formal instructions for active mobilization of the wrist.

Comparison treatment: Closed reduction and plaster immobilization

Wrist was immobilized with a short-arm cast at the emergency unit.

Patients were scheduled to

attend follow-up visits at 1 and 2 weeks after treatment. If the reduction met the acceptable criteria, immobilization was

continued for 6 weeks, after which the cast was removed and active mobilization of wrist was started.

Operative treatment with a palmar plate was offered when there was greater than 10° dorsal angulation of the articular surface on the lateral radiograph, less than 15° of radial inclination or greater than 2mm ulnar positive variance on the posteroanterior radiograph

within 2 weeks after injury.

If patient declined surgery, nonoperative treatment was continued until fracture union. In the case of delayed surgery in the control group, the postoperative follow-up and rehabilitation program was identical to that of the intervention group.

Length of follow-up:

12 months, 24 months (included in analysis)

Loss-to-follow-up, n/N (%):

Intervention:

5/38 (13%)

Reasons: lost interest (n=2), moved (n=1), died unrelated to treatment (n=1), lost contact (n=1)

Control:

7/42 (17%)

Reasons: lost interest (n=3), hip fractures (n=2), lost contact (n=1), unknown (n=1)

Incomplete outcome data:

Not described

Function

defined as DASH score;

0 to 100, with 0 indicating no disability; mean;

I: 7.2

C: 14.4

P=0.005

diff.−7; CI −13 to −1.5

defined as range of motion;

in °; mean (SD)

Extension

I: 69 (6)

C: 68 (7)

diff. 1°, 95% CI –2 to 4

Flexion

I: 71 (7)

C: 64 (11)

diff. 7°, CI 3–12

Radial deviation

I: 22 (6)

C: 22 (5)

diff. 0°, CI –3 to 3

Ulnar deviation

I: 28 (5)

C: 25 (6)

diff. 3°, CI 1–6

Pronation

I: 88 (5)

C: 88 (6)

diff. 0°, CI –2 to 3

Supination

I: 88 (5)

C: 84 (10)

diff. 3°, CI –1 to 7

Complications

Secondary treatment

I: 1/33, C: 3/35

(reason;

I: 1 CTS;

C: 2 CTS, 1 malunion)

Tendon injury/rupture

Flexor tenosynovitis

I: 1/33, C: 0/35

Nerve injury (also CTS)

CTS

I: 1/33, C: 4/35

In analysis limited to patients of ≥ 65y, DASH

scores at the 2-year follow-up did not differ

between intervention and control group: 11 versus.17

(diff., −6; CI −18 to 4; p = 0.2).

For the patients <65y the mean DASH for the intervention and control group was 6 versus. 11

(diff, −5; CI −12 to –1;

p = 0.01).

Martinez-Mendez, 2018

Type of study:

RCT

Setting and country:

Department of Orthopaedic Surgery, Elda University Hospital & Faculty of Health Sciences, University of Alicante, Spain

Funding and conflicts of interest:

no financial support was received, no potential conflicts of interest were reported.

Inclusion criteria:

• displaced complex intra-articular distal radius fracture (Arbeitsgemein-schaft für Osteosyn-thesefragen (AO) type C) (Müller et al., 1990)
• age 60 years or older

Exclusion criteria:

• open fracture (n=1)
• previous stroke (n=1)
• decline to participate (n=2)

N total at baseline:

Intervention: 50

Control:47

Age ± SD:

I: 67 (8)

C: 70 (7)

P=0.19

Sex, n/N (%) male:

I: 10/47 (21%)

C: 11/50 (22%)

P=0.56

Groups comparable at baseline.

Intervention:

Closed reduction and internal fixation with a volar locking plate

In emergency department, closed reduction under intrafocal anaesthesia (mepivacaine 2%), fluoroscopy control, and below-the-elbow plaster

immobilization after acceptable reduction had

been obtained.

Surgery: Open reduction and volar locking plate fixation (titanium Acu-Loc 2, Acumed, Hillsboro, OR, USA; and VALCP, Synthes, Switzerland) through a standard Henry approach. All surgeries were performed by the same surgeon team who had performed the closed reduction in the emergency room. The operations were performed under brachial plexus anaesthesia, tourniquet, and fluoroscopy control. The time from injury to surgery was between 2 and 5 days. Allograft was used for subchondral support in 12 patients.

A below-the-elbow

plaster splint was applied for 1 week for comfort.

After the plaster was removed, all patients in

both groups received physical therapy until the maximum possible improvement in wrist motion and pain relief was reached.

Comparison treatment: Closed reduction and plaster immobilization

In emergency department, closed reduction under intrafocal anaesthesia (mepivacaine 2%), fluoroscopy control, and below-the-elbow plaster

immobilization after acceptable reduction had

been obtained.

Patients in the conservative group continued with

plaster immobilization. After 2 weeks, the plaster was changed to a forearm cast for four more weeks.

After the plaster was removed, all patients in

both groups received physical therapy until the maximum possible improvement in wrist motion and pain relief was reached.

Length of follow-up:

24 months

(mean: 29 (24-48))

Loss-to-follow-up:

No loss to follow up

Incomplete outcome data:

Not described

Function

defined as DASH score;

0 to 100, with 0 indicating no disability; mean (SD);

I: 16 (14)

C: 28 (21)

p=0.04

defined as PRWE score,

range, 0 to 100, with 0 indicating asymptomatic patient); mean (SD)

Total score

I: 17 (13)

C: 30 (25)

p=0.03

Function component

I: 9 (7)

C: 17 (13)

p=0.02

defined as ROM, in degrees, mean (SD);

Flexion

I: 54 (13)

C: 60 (16)

p=0.18

Extension

I: 57 (11)

C: 54 (13)

p=0.45

Supination

I: 85 (8)

C: 72 (20)

p=0.01

Pronation

I: 84 (10)

C: 71 (19)

p=0.01

Pain

defined as PRWE - Pain component; mean (SD)

I: 8 (6)

C: 13 (12)

p=0.04

defined as score on VAS scale from 0 (no pain) to 10 (severe pain); mean (SD);

I: 2 (2)

C: 3 (2)

p=0.03

Sharma, 2014

Type of study:

(quasi) RCT

Setting and country:

Funding and conflicts of interest:

Funding not reported, no conflicts of interest reported

Inclusion criteria:

• Unilateral fractures of distal radius (AO type B or C)
• Age >25 to <55 years
• Duration <1 week old

Exclusion criteria:

• Open fractures, bilateral fractures, fractures of more than 1 week duration and AO type A fractures.
• Associated fractures of carpal bones and bones of the hand or any other bone of the involved limb.
• Nerve injury and pathological fractures.
• Isolated fracture of radial styloid (which also comes under AO type B).

N total at baseline: 64

Intervention: 32

Control: 32

Important demographics:

Age, mean ± SD:

I: 52.4y ± 9.1

C: 48.1 ± 10.3

Sex, n/N (%) male:

I: 12/32 (38%)

C: 14/32 (44%)

Groups comparable at baseline.

Intervention:

Closed reduction and internal fixation with a volar locking plate

Open reduction and internal fixation with titanium volar locking plates (Synthes) through an extended flexor carpi radialis approach. Operations were

performed by the same surgeon in all cases, and the implant used was of the same manufacturer (Synthes) in all cases. In the postoperative period, a plaster splint (below elbow

wrist brace) was applied for 1 week for comfort, and free movement of fingers was allowed.

Both groups participated

in a formal outpatient therapy program supervised by a qualified physio-therapist, with emphasis on active and passive range of finger, wrist, elbow and shoulder motion

exercises.

The operative group were put through finger,

wrist, elbow and shoulder motion exercises from 1 week after surgery.

After plaster removal at 4 weeks, exercises were

started for all the joints.

Physiotherapy assistance continued for 2 months from the injury in both groups on a biweekly basis.

Comparison treatment: Closed reduction and plaster immobilization

Closed manipulation under C-arm guidance and above elbow plaster of Paris (POP) cast application for 4 weeks

Both groups participated

in a formal outpatient therapy program supervised

by a qualified physio-therapist, with emphasis on active and passive range of finger, wrist, elbow and shoulder motion

exercises.

Both groups participated

in a formal outpatient therapy program supervised

by a qualified physio-therapist, with emphasis on active and passive range of finger, wrist, elbow and shoulder motion

exercises.

The plaster group could do only finger and shoulder exercises for the initial 4 weeks for obvious reasons.

Physiotherapy assistance continued for 2 months from the injury in both groups on a biweekly

basis.

Length of follow-up:

6 weeks, 12 months, 24 months (included in analysis)

Loss-to-follow-up:

Not described

Incomplete outcome data:

Not described

Function

defined as DASH score;

0 to 100, with 0 indicating no disability; mean (SD);

I: 4.96 ± 9.42

C: 14.04 ± 10.20

defined as ROM, % compared to uninjured side, mean (SD);

Flexion (palmar flexion)

I: 83.86 ± 2.98

C: 65.91 ± 7.53

P<0.001

Extension (dorsal flexion)

I: 84.33 ± 2.41

C: 69.04 ± 3.91

P<0.001

Radial deviation

I: 79.14 ± 3.73

C: 62.87 ± 6.68

P<0.001

Ulnar deviation

I: 79.62 ± 3.00

C: 65.91 ± 5.42

P<0.001

Pronation

I: 34.19 ± 2.69

C: 32.04 ± 2.91

P=0.088

Supination

I: 43.43 ± 3.58

C: 41.96 ± 3.91

P=0.932

Pain

Not defined

“In our study pain scores were low throughout the study in both groups.”

Complications

Secondary treatment

I: NR

C: NR

Infection

I: 1/32

C: 0/32

Tendon injury/rupture

I: 2/32

C: 0/32

Nerve injury

Carpal tunnel syndrome (CTS)

I: 1/32

C: 7/32

Complex regional pain syndrome (CRPS)

I: NR

C: NR

Remarks:

-quasi randomized

-not all results clearly described (e.g. pain scores)

Author’s conclusion:

In cases of AO type B or C fractures of the

distal radius, volar locked plating provides anatomical

stable fixation and early mobilization with better clinico-radiological

outcome as compared to conservative treatment.

Bartl, 2014

Type of study:

RCT, multi-centre

Setting and country:

12 centres, Germany

Funding and conflicts of interest:

Funding and conflicts of interest:

Inclusion criteria:

Men and women

> 65 years of age

with a radiologically

confirmed, closed, unstable intra-articular fracture of the distal radius according to the AO criteria (fracture types 23-C1 to C3)

Exclusion criteria:

No additional criteria described

N total at baseline: 174

Intervention: 86

Control: 88

Important demographics:

Age, mean (SD):

I: 75.3 ± 6.7

C: 74.4 ± 7.1

Sex, n/N (%) male:

I: 9/86 (10%)

C: 12/88 (14%)

AO fracture type:

I: 23-C1 – 36 (42%)

 23-C2 – 35 (41%)

 23-C3 – 15 (17%)

C: 23-C1 – 40 (46%)

 23-C2 – 35 (40%)

 23-C3 – 13 (15%)

Groups comparable at baseline.

Intervention:

Closed reduction and internal fixation with a volar locking plate

Treatment primarily or

after soft-tissue conditioning by open reduction with volar locking plate fixation via the volar Henry approach.

The protocol permitted the use of implants from any manufacturer according to local standards and

depending on availability.

These patients were prescribed physiotherapy according to the standards of the individual center 2 weeks after surgery.

Comparison treatment: Closed reduction and plaster immobilization

Initial treatment with closed reduction and immobilization in a dorsoradial plaster cast.

Patients in the nonsurgical group were treated with a

closed forearm cast for 6 weeks, followed by physiotherapy according to local standards.

The protocol permitted

conversion to secondary surgical treatment in

the case of significant loss of reduction or pronounced

joint incongruence.

Length of follow-up:

12 months

I: 68

C: 81

Loss-to-follow-up:

I: N = 18 (21%)

C: N = 7 (8%)

Reasons not specified; SAE’s describe 5 deaths (4 in intervention, 1 in control group)

Incomplete outcome data:

Not specified

Function

defined as DASH score;

0 to 100, with 0 indicating no disability; mean±SD;

3 months

I: 22.7 ± 16.7

C: 28.2 ± 20.5

P=0.071

12 months

I: 14.0 ± 16.1

C: 19.0 ± 21.3

P=0.102

defined as ROM, in degrees, mean difference between fractured and unaffected side, mean±SD;

Extension

I: 7.5 ± 11.7

C: 7.5 ± 10.0

P=0.982

Flexion

I: 8.2 ± 11.9

C: 11.5 ± 12.8

P=0.143

Ulnar deviation

I: 4.4 ± 7.5

C: 5.9 ± 8.0

P=0.290

Radial deviation

I: 3.9 ± 6.3

C: 3.0 ± 5.7

P=0.433

Supination

I: 2.5 ± 5.9

C: 3.2 ± 8.3

P=0.603

Pronation

I: 2.8 ± 5.6

C: 2.6 ± 9.4

P=0.892

Pain

NR

Complications, n/N:

Secondary treatment

I: 4/84

C: 39/90

 Reduction loss necessitating

 Revision

 I: 0/84

 C: 37/90

 Malposition of implant

 necessitating revision

 I: 4/84

 C: 2/90

Infection

Wound infection

I: 0/84

C: 0/90

Tendon injury/rupture

I: 1/84

C: 2/90

 Rupture of extensor tendons

 I: 1/84

 C: 1/90

 Rupture of flexor tendons

 I: 0/84

 C: 1/90

Nerve injury

I: 1/84

C: 5/90

 Carpal tunnel syndrome

 I: 1/84

 C: 2/90

 Nerve lesion

 I: 0/84

 C: 3/90

Complex regional pain syndrome (CRPS)

I: 0/84

C: 1/90

Remarks:

High proportion of non-surgical group received secondary operative treatment (41%)

Author’s conclusions:

The findings with respect to mobility, functionality, and quality of life at 12 months provide marginal and inconsistent evidence for the superiority of volar angle-stable plate osteosynthesis over closed reduction and casting in the treatment of intra-articular distal radius fractures. Primary nonsurgical management is also effective in suitable patients.

Arora, 2011

Type of study:

Prospective RCT

Setting and country:

Department of Trauma Surgery and Sports Medicine, Medical University Innsbruck, Innsbruck, Austria

Funding and conflicts of interest:

There was no external source of funding for this study, no conflicts reported.

Inclusion criteria:

• Age ≥65y
• meet one or more of the inclusion criteria. Primary reduction of the fracture was considered to be acceptable when the dorsal radial tilt did

not exceed 10°, radial shortening was not more than 3 mm, and any intraarticular step-off did not exceed 2 mm6.

Exclusion criteria:

Patients with stable fractures were excluded from the study.

N total at baseline: 90

Intervention: 45

Control: 45

Important demographics:

(I: n=36, C: n=37)

Age, mean (range):

I: 75.9 (65 to 88)

C: 77.4 (65 to 89)

Sex, n/N (%) male:

I: 8/36 (22%)

C: 10/37 (27%)

Also in manuscript: dominant side, injured side, AO fracture classification

Groups comparable at baseline.

Intervention:

open reduction and internal fixation with volar

fixed-angle implant

Initial fracture reduction under local anesthesia and

fixed with forearm plaster cast in the emergency department.

Surgery took place 14 days after injury and was performed with use of either brachial plexus block

(n=25) or general anesthesia and an upper arm tourniquet (n=11). The

distal part of the radius was exposed through a palmar approach along the flexor carpi radialis tendon. After the release of the pronator quadratus muscle, the fracture site was exposed. Fracture reduction was achieved with the assistance of an image intensifier, and the fracture site was temporarily stabilized with Kirschner wires. The volar fixed-angle plate (2.4-mm LCP DRP (Synthes, Salzburg, Austria) (n = 4) or DVR (Hand Innovations, Miami, Florida) (n = 32)) was placed on the volar radial cortex and was first fixed at the gliding hole to allow appropriate positioning for the image-controlled subchondral placement of the interlocking screws. If possible, the pronator quadratus muscle was

reinserted to protect the flexor tendons.

After surgery, the wrist was

immobilized in a below-the-elbow splint for pain reduction. The active digital

range of motion was started immediately.

Ten days after surgery, the sutures were removed and the wrist was placed in a removable splint for another week.

At that time, physiotherapy with active and passive wrist mobilization out of the

splint was started.

Comparison treatment:

closed reduction and plaster immobilization

Initial fracture reduction under local anesthesia and

fixed with forearm plaster cast in the emergency department.

No repeated manipulation was done for fractures that were treated nonoperatively.

Wrist was immobilized in a short arm cast in a neutral position for 5 weeks. The active digital range of

motion was started immediately.

After cast removal, physiotherapy was started.

Length of follow-up:

12 months

I: 36

C: 37

Loss-to-follow-up:

I: 9/45 (20%)

C: 10/45 (22%)

Reasons;

I: died (n=4), lost to follow up (n=5)

C: died (n=4), lost to follow up (n=6)

Incomplete outcome data:

Not described

Function

defined as DASH score;

0 to 100, with 0 indicating no disability; mean±SD;

6 weeks

I: 18.8 ± 17.9

C: 34.4 ± 22.5

P=0.00

12 weeks

I: 13.3 ± 14.8

C: 23.2 ± 19.3

P=0.02

6 months

I: 12.2 ± 14.4

C: 12.4 ± 17.0

P=0.94

12 months

I: 5.7 ± 11.1

C: 8.0 ± 9.3

P=0.34

defined as PRWE score;

range, 0 to 100, with 0 indicating asymptomatic patient); mean±SD:

6 weeks

I: 36.4 ± 28.7

C: 64.9 ± 29.0

P=0.00

12 weeks

I: 33.7 ± 32.0

C: 54.4 ± 31.8

P=0.01

6 months

I: 27.7 ± 32.0

C: 31.4 ± 33.0

P=0.63

12 months

I: 12.8 ± 23.2

C: 14.6 ± 22.8

P=0.73

defined as ROM, in degrees, mean±SD (% ‘normal’ side):

Extension

I: 59 ± 10 (94.4%)

C: 61 ± 7 (106.6%)

P=0.14

Flexion

I: 55 ± 11 (91.1%)

C: 57 ± 10 (100.7%)

P=0.50

Ulnar deviation

I: 35 ± 8 (101.6%)

C: 35 ± 8 (102.4%)

P=0.88

Radial deviation

I: 24 ± 6 (98.0%)

C: 25 ± 7 (114.9%)

P=0.52

Supination

I: 85 ± 8 (99.6%)

C: 85 ± 8 (100.4%)

P=0.99

Pronation

I: 84 ± 7 (99.4%)

C: 85 ± 8 (100.8%)

P=0.53

Pain

defined as wrist pain VAS; range 0-10 with 0 indicating no pain and 10 indicating severe pain; mean±SD:

Pain at rest

I: 0.1 ± 0.3

C: 0.1 ± 0.5

P=0.80

Pain under stress

I: 0.7 ± 1.0

C: 0.6 ± 1.4

P=0.80

Complications

NR

Secondary treatment

Not clearly described

Infection

NR

Tendon injury/rupture

I: 10/36

C: 0/37

 Extensor tenosynovitis

 I: 5/36

 C: 0/37

 Flexor tenosynovitis

 I: 4/36

 C: 0/37

 Extensor pollicis longus

 tendon rupture

 I: 1/36

 C: 0/37

Nerve injury

CTS

I: 1/36

C: 0/37

Complex regional pain syndrome (CRPS)

I: 2/36

C: 5/37

Remarks:

Author’s conclusions:

At the twelve-month follow-up examination, the range of motion, the level of pain, and the PRWE and DASH scores were not different between the operative and nonoperative treatment groups. Patients in the operative treatment group had better grip strength through the entire time period. Achieving anatomical reconstruction did not convey any improvement in terms of the range of motion or the ability to perform daily living activities in our cohorts.

Földhazy, 2010

Type of study:

RCT

Setting and country:

Karolinska

University Hospital Huddinge &

Stockholm

Söder Hospital, Sweden

Funding and conflicts of interest:

The study was supported by grants from the Karolinska Institute Research Funds, Stockholm, Sweden and from King Gustav V and Queen Victoria’s

foundation, Stockholm, Sweden. Conflicts of interest not reported.

Inclusion criteria:

• Age 60-85y
• Distal radial fracture

 -following low-energy trauma (in most cases a simple fall at the same level)

 -not older than 3 days

 -dorsal angulation radiographically ≥40° from normal or the radius ≥5mm shortened in relation to distal ulna.

Both extra-articular and intra-articular fractures were included.

Exclusion criteria:

• Patients with concomitant conditions that, beside the fracture, might influence their hand function or demands
• Patients that could not

 perform basic activities of daily living (ADL) since our assumption was that their physical demands were low and a difference between the two treatments regimens would be difficult to reveal.

• Patients with severe

cognitive dysfunction

• Patients unable to

understand spoken or written information

N total at baseline: 59

Intervention: 28

Control: 31

Important demographics:

Age, mean (range):

I: 73 (60-85)

C: 70 (62-81)

Sex, n/N (%) male:

I: 4/28 (14%)

C: 2/31 (6%)

Groups comparable at baseline?

Intervention:

closed reduction and external fixator

Provisional reduction and dorsal plaster splint at emergency department.

Operative treatment at the next available occasion. A new closed reduction was performed and a standard external fixator was applied with 2 pins inserted into the radius proximal to the fracture using an open

technique and 2 pins in the second metacarpal with a

percutaneous technique.

Although, according to the study protocol, adjunctive percutaneous pins were allowed, none were used.

5 weeks of immobilization.

Physiotherapy only prescribed when indicated (n=5).

Comparison treatment:

closed reduction and plaster immobilization

Closed reduction using regional anesthesia

(hematoma infiltration n=3, intravenous regional anaesthesia n=28) at emergency department. Wrist was immobilized with dorsal plaster splint reaching to below the elbow.

No re-reductions were necessary during

the follow-up.

The plaster was retained for 5 weeks.

Physiotherapy only prescribed when indicated (n=9).

Length of follow-up:

12 months

I: 22

C: 29

Loss-to-follow-up:

I: 6/28 (%)

C: 2/31 (%)

Reasons:

Abandoned 1Y follow-up (n=4), insufficient cooperation (n=3, of which 1 dementia), exclusion by the authors because of erroneous inclusion (n=1, fracture not displaced enough).

Incomplete outcome data:

Not described, but 2 patients excluded due to incomplete data

Function

defined as ROM, in degrees,

Extension (dorsal extension?)

I: 46.3 ± 2.7

C: 49.5 ± 2.9

Flexion (volar flexion?)

I: 56.0 ± 2.9

C: 63.9± 2.3

Ulnar deviation

I: 33.7 ± 2.0

C: 29.8 ± 2.0

Radial deviation

I: 21.3 ± 1.3

C: 17.5 ± 1.3

Supination

I: 75.8 ± 2.8

C: 78.2 ± 2.0

Pronation

I: 68.9 ± 2.5

C: 72.9 ± 2.1

Pain

No data reported, only described: no differences between groups

Secondary treatment

NR

Complications

Infection

in track infection

I: 4/22

C: 0/29

Tendon injury/rupture

rupture of the extensor pollicis longus tendon

I: 1/22

C: 0/29

Nerve injury

I: 3/22

C: 2/29

Iatrogenic radial sensible nerve injury

I: 1/22

C: 0/29

CTS

I: 2/22

C: 2/29

Complex regional pain syndrome (CRPS)

I: 2/22

C: 2/29

Remarks:

Scores often not specified; data presented in box plots.

Author’s conclusions:

Primary external fixation of displaced distal radial fractures in 60--85-year-old patients had a positive effect on the radiographic result but did not have any clinical benefits compared to cast treatment.

Study reference

(first author, publication year)

Describe method of randomisation

Bias due to inadequate concealment of allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?

(unlikely/likely/unclear)

Bias due to loss to follow-up?

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?

(unlikely/likely/unclear)

Arora, 2011

Sequentially numbered, sealed enveloped

“After the study nurse had obtained patient consent, the patients were randomized to either ORIF or nonoperative treatment with use of sequentially numbered, sealed envelopes.”

Unlikely

Adequate procedure

Likely

Not described

Unclear

Not described

Likely

Clinical assessor not blinded

“At each visit, a clinical examination was performed by an independent examiner

who was not blinded to the method of treatment because the palmar scars in the

operative treatment group could be easily observed.”

Unclear

No protocol available.

Outcome variables that are mentioned in methods are included in the results section.

Unlikely

Reasons described and comparable between groups

“Four patients in the operative treatment group and two patients in the nonoperative treatment group died of unrelated conditions before the latest follow-up examination and were excluded. Five patients from the operative treatment group and six patients from the nonoperative

treatment group were lost to follow-up and were excluded.”

Unclear

Individuals lost to follow up and death were excluded from analysis

Bartl, 2014

Computerized

“Random, center-stratified block

assignment on a 1:1 basis was achieved by means of the online resource www.randomizer.at.”

Unlikely

Adequate procedure

Likely

Not described

Unclear

Not described

Likely

Not described

Unclear

Protocol available, not all expected outcome measures described (e.g. need for pain medication)

“The study was registered at current controlledtrials.com (ISRCTN 76120052).”

Unclear

More study drop-outs in interventions group (18/84 versus. 7/88)

Unlikely

Inconsistent numbers in flow chart, but probably ITT analysis was performed.

“The primary analysis was oriented on the intention-to-treat (ITT) principle; all patients were analysed

according to their random treatment assignment.”

Földhazy, 2010

Closed envelopes

“The randomization procedure was conducted at the emergency department using closed envelopes.”

Unlikely

Adequate procedure

Likely

Not described

Unclear

Not described

Likely

Not described

Unclear

No protocol available.

Outcome variables that are mentioned in methods are included in the results section

Unclear

Reasons described, unclear whether difference between groups might induce bias.

Unclear

Individuals lost to follow up were excluded from analysis

Martinez-Mendez, 2018

Opaque envelopes

“Randomization was performed by the

method of random number generation provided in opaque envelope.”

Unlikely

Adequate procedure

Likely

Unclear

Not described

Unlikely

Assessors blinded at 12 and 24 months

“The clinical and radiological assessments could not

be blind because of the presence of incision and hardware in the surgical patients. However, assessments

at annual follow-up were performed by an independent observer not involved in the treatments.”

Unclear

No protocol available

Unlikely

No lost to follow up

“Final follow-up data were obtained at

least 24 post-injury months for all patients with a mean follow-up of 29 months”

Unclear

Loss to follow up not described

Mulders, 2019

Computerized

“Randomization

was performed by means of a secured online computerized

randomization procedure, using mixed block sizes of 2, 4, 6, and 8. Randomization was stratified according to age into 3 strata (18

to 30, 31 to 60, and 61 to 75 years old).”

Unlikely

Adequate procedure

Likely

“Because the assignment involved a surgical procedure, neither participants nor treating physicians were blinded to the treatment allocation.”

Unclear

“Because the assignment involved a surgical procedure, neither participants nor treating physicians were blinded to the treatment allocation.”

Likely

“Clinical assessment

was performed by an independent examiner who was not blinded

to the allocated treatment because the scars on the palmar side of the wrist in the operative group could easily be observed.”

Unlikely

Protocol available

“The trial protocol has previously been published.”

Primary outcome from protocol included, not all secondary outcomes (VAS pain, patient satisfaction).

Unlikely

Unclear

Individuals lost to follow up were excluded from analysis

“All analyses were performed according to the intention-to-treat

principle.”

Saving, 2019

Concealed envelopes

“Randomization

was performed in a 1:1 ratio using concealed

opaque envelopes without stratification.”

Unlikely

Adequate procedure

Likely

“Patients were not blinded to the

allocation, nor were investigators.”

Unclear

“Patients were not blinded to the

allocation, nor were investigators.”

Likely

“Patients were not blinded to the

allocation, nor were investigators.”

Unlikely

Studies in clinical trial register. Relevant outcome measures included in publication.

Unlikely

Reasons drop out described.

Unclear

Individuals lost to follow up were excluded from analysis

“All results were analyzed according to the intention-to-treat principle.”

Sharma, 2014

Even / odd numbers, not further specified

“by alternate

randomization: 32 patients with odd numbers went into the nonoperative group and the other 32 with even numbers

went into the volar plating group.”

Likely

Inadequate procedure

Likely

Not described

Unclear

Not described

Likely

Not described

Unclear

No protocol available

Unclear

Intervention group: 18 study drop outs; control group: 7 study drop outs. Reasons not provided.

Unclear

Not described

Sirnio, 2019

Sealed opaque envelopes

“Patients were randomly allocated into study groups based on a computer-generated list. Randomization was performed in blocks, with block sizes randomly varying

between 4, 6, 8, and 12. Separate lists were created for age groups of < 65 and ≥ 65 years, and for type A and C

fractures. Randomization lists were sealed into numbered opaque envelopes.”

Unlikely

Adequate procedure

Likely

Not described

Unclear

Not described

Likely

Not described

Unclear

No protocol available.

Unlikely

Reasons drop out described, percentage of drop-out per group similar

Unlikely

All available data included in analysis according to allocation; missing data was imputed.