Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Selim 2022

Study characteristics and results are extracted from the SR (unless stated otherwise)

PICO 1

SR and meta-analysis of RCTs and observational studies

Literature search up to December 2021

a: Agren, 2013

b: Bahari Kashani, 2013

c: Buckley, 2002

d: Dickenson, 2021

e: Griffin, 2014

f: Ibrahim, 2007

g: Nouraei, 2011

h: Parmar, 1993

i: Sharma, 2011

j: Thordarson , 1996

Study design: a t/m j: RCT

Setting and Country:

a: , Sweden

b: , Iran

c: , Canada

d: , UK

e: , UK

f: , UK

g: , Iran

h: , England

i: , India

j: , USA

Source of funding and conflicts of interest:

Only reported for the systematic review – no conflicts of interest

Inclusion criteria SR:

- studies directly comparing nonoperative and operative management of intraarticular calcaneal fractures

- RCT and prospective comparative

- studies in English

- studies in human

Exclusion criteria SR:

- cadaveric studies

- biomechanical studies of treatment options

- abstracts, case reports, systematic reviews and retrospective studies

13 studies included in the review, of which 10 were considered relevant (a t/m j)

Important patient characteristics at baseline:

Total population i/c

a: 39/37

b: 84/56

c: 206/218

d: 52/66

e: 73/78

f: 15/11

g: 31/30

h: 25/31

i: 15/15

j: 15/11

Mean age i/c  (% male)

a: 49/48 (not reported)

b: not reported (79)

c: 41/39 (90)

d: 45 (not reported)

e: 45/48 (not reported)

f: 61/58 (91)

g: 46/52 (not reported)

h: 48/48 (86)

i: 28/29 (70)

j: 35/36 (91)

Groups comparable at baseline?

Probably yes

Operative (ORIF)

Conservative

End-point of follow-up:

“The mean follow-up period in the included studies was 4.1 years”

Follow-up (years)

a: 12/12

b: not reported

c: 3/3

d: 5/5

e: 2/2

f: 15/15

g: 3/3

h: 2/2

i: 2/2

j: 1/1

Outcome measure-1 AOFAS

Effect measure: mean difference [95% CI]:

a: -3,1 (95% CI: -9.65, 3.45)

e: -2.40 (95% CI: -8.14, 3,34)

f: 5,8 (95% CI: -5,98, 17,58)

j: -31,7 (95% CI: -45,72, -17,68)

Pooled effect (random effects model):

6.68 (95% CI: -3.88, 17.24) favoring operative

Outcome measure-2 complications

Effect measure: RR  [95% CI]:

a: 20.84  (95% CI: 1.25, 346.98)

b: 0.11  (95% CI: 0.03, 0.48)

c: 1.37 (95% CI:  0.96, 1.95)

e: 11.95 (95% CI:  3.73, 38.23)

h: 1.65  (95% CI: 0.66, 4.14)

NA

j: 2.25  (95% CI: 0.10, 50.54)

Pooled effect (random effects model):

1.91  (95% CI: 0.61, 5.94), favouring conservative

Outcome measure-3 arthritis

Effect measure: RR  [95% CI]:

a: 0.57  (95% CI: 0.33, 0.99)

b: 2.78  (95% CI: 1.63, 4.73)

d: 1.69  (95% CI: 0.40, 7.23)

e: 7.47  (95% CI: 0.39, 142.23)

f: 1.10  (95% CI: 0.56, 2.17)

g: 0.36 (95% CI: 0.11, 1.24)

Pooled effect (random effects model):

1.16 (0.54 – 2.50)

 favouring conservative

The author’s concluded that:

“DIACF management should be individualized, and opera- tive treatment has to be reserved for selected cases with cer- tain patient factors and fracture patterns. (…)Fracture patterns with fibular impingement, significant lat- eral comminution, and large Böhler angle show better out- comes with the operative treatment”

Sensitivity analyses

“The AOFAS-score favored the ORIF group when Ibrahim et al’s study was removed; however, the study was well conducted and demonstrated a low risk of bias in the quality assessment. Therefore, no good reason was noted to exclude it from the results”

“Complications demonstrated a statistically significant result, favoring the conservative treatment when Bahari Kashani et al’s study was removed”

The studies that were not considered relevant for the purpose of this guideline were excluded based on studies design (observational studies).

One study did not report any of the predefined outcome measures i - Sharma)

Peng 2021

Study characteristics and results are extracted from the SR (unless stated otherwise)

PICO 2

SR and meta-analysis of RCTs and observational studies

Literature search up to June 2019

a: Bin Jia, 2017

b: Cheng, 2017

c: Li, 2016

d: Xia, 2014

e: Zhu, 2013

b + e: full tekst of individual study not available

Study design: a t/m e: RCT

Setting:  not reported

Source of funding and conflicts of interest:

Only reported for the systematic review – no conflicts of interest

Inclusion criteria SR:

- adult calcaneal fracture patients

- studies comparing postoperative functional outcomes of calcaneal fractures via ELA and STA

- studies reporting at least 1 of the following outcomes postoperative calcaneal height, postoperative calcaneal width, complications (marginal necrosis, postoperative infection, and nerve injury), operative time, length of hospital stay, postoperative Böhler angle, postoperative Gissane angle, and AOFAS-scores;

- Cohort studies, controlled clinical trials and RCTs

Exclusion criteria SR:

- animal cadaveric studies

- studies in which valid data cannot be extracted or converted

- case reports, systematic reviews and meta-analyses, conference papers without full text.

18 studies included in the review, of which 5 were considered relevant (a t/m e)

Important patient characteristics at baseline:

Total population n i/c

a: i: 60/ c: 60; 

b: i: 33/ c:33; 

c: i: 32/ c:32; 

d: i: 64/ c:53; 

e: i: 18/ c:20; 

Mean age i/c

a: i: 38.6 / c: 35.8

b: i: 36.2 / c: 35.1

c: i: 40 / c: 41

d: i: 38 / c: 37

e: i: 36.6 / c: 36.4

a: Sinus tarsi approach; plates

b: sinus tarsi approach; plates

c: sinus tarsi approach; plates

d: sinus tarsi approach; plates

e: sinus tarsi approach; plates

a: Extended lateral approach; plates

b: Extended lateral approach; plates

c: Extended lateral approach; plates

d: Extended lateral approach; plates

e: Extended lateral approach; plates

Duration of follow-up:

a: 12 months

b: not reported

c: 12 months

d: 28 months

e: 15 months

Outcome measure 1: Bohler’s angle

MD (95% CI)

a: 4.30 (95% CI: 3.12, 5.48)

b: 1.50 (95% CI: -0.38, 3.38)

c: -1.50 (95% CI: -3.45, 0.45)

d: 0.70 (95% CI:  -0.76, 2.16)

e: -1.10  (95% CI: -2.44, 0.24)

pooled effect: 0.82 (95%CI: -1.47, 3.11)

Outcome measure 2: AOFAS

MD (95% CI)

b: 1.60  (95% CI: -1.80, 5.00)

c: 0.50  (95% CI: -3.45, 4.45)

e: -1.40  (95% CI: -3.70, 0.90)

pooled effect: -0.21 (95%CI: -2.06, 1.64)

Outcome measure 3 complications

RR (95% CI)

Wound infection

a: 0.33 (95% CI: 0.04, 3.11)

b: 0.50 (95% CI: 0.10, 2.55)

c: 0.40  (95% CI: 0.08, 1.91)

d: 0.17 (95% CI:  0.01, 3.39)

Nerve injury

a: 0.11 (95% CI: 0.01, 2.02)

pooled effect:

0.34 (95% CI: 0.14, 0.84)

The author’s concluded that:

“compared with ELA, an STA is superior in the treatment of calcaneal fractures, due to effective anatomical reduction of the calcaneus, effective reduction of the incidence of incision complications, and shortened operative time and postoperative hospital stay”

The studies that were not considered relevant for the purpose of this guideline were excluded based on studies design (observational studies).

The author’s of the review stated that Basile 2016 was a RCT, however after consulting the full text, the trial appeared to be non-randomized.

Jadad Quality score for RCT

a: 5

b: 4

c: 6

d: 5

e: 3

Some concerns regarding the quality of the systematic review. After consulting some of the full text papers, there appear to be some inconsistencies

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

PICO A

Hussain 2022

Type of study:

RCT

Setting and country:

Single Centre, Pakistan 2021 to 2022

Funding and conflicts of interest:

none

Inclusion criteria

- Patients with displaced intra-articular calcaneal fractures

Exclusion criteria

- patients with calcaneal fractures connected with spinal injuries, pathological fractures, peripheral vasculopathy or any medical contraindication to surgery

N total at baseline:

I:  n = 16

C: n = 16

Important prognostic factors:

All patients had Sander’s type II and III closed fractures that were less than 3 weeks old.

Age

i: 40 years

c: 42 years

Sex M/F

In total study population: 11/32 (34%)  female

Groups comparable at baseline?

Probably yes

Operative treatment

Group B

Conservative treatment

Group A

Length of follow-up:

1 year

Loss-to-follow-up:

No loss-to-follow-up was reported

Böhler’s angle, mean

I: 29.22

(opposite ‘healthy’ site: 31.1)

C: 11.21

(opposite ‘healthy’  site: 25)

à No standard deviations reported

di

Author’s conclusion:

“operative treatment is a better and more effective method to treat displaced intra-articular calcaneal fractures”

PICO B: PRF vs ELA

Chen 2011

(from Shi 2020)

Type of study:

RCT

Setting and country:

Single Centre, USA 2006 - 2008

Funding and conflicts of interest:

None

Inclusion criteria:

- Displaced intra-articular calcaneal fracture (more than 2 mm)

- operative treatment possible within 7 days of injury

- unilateral fracture

- closed fracture

Exclusion criteria:

- Patients with known local or systemic infection,

- medical contraindication

- Sanders type IV, Sanders type IIA and open fractures

N total at baseline:

PR + CSC: 38

ORIF, ELA: 40

Important prognostic factors²:

age:

PR + CSC: 31.1

ORIF, ELA: 32.7

Sex: M/F

PR + CSC:  20/18

ORIF, ELA: 24/16

Sanders Type II/III:

PR + CSC:  29/9

ORIF, ELA: 32/8

Groups comparable at baseline?

Probably yes

Percutaneous reduction (PR), cannulated screw fixation and calcium sulphate cement (CSC) grafting

PR + CSC

In the percutaneous treatment group, we crossed the tuberosity with a 6.5-mm Schanz pin via stab incision to reduce the height and length of calcaneus. Then, we

introduced a 6.5-mm Schanz pin into the fragment with the

displaced posterior facet and levered the compressed facet under fluoroscopic guidance. In Sanders Type III fractures,

another Schanz pin was introduced percutaneously through the lateral cortex of the inferior calcaneus to unlock and push up any remaining depressed parts of the subtalar joint surface

of the calcaneus. Once the Böhler’s angle and articular

surface were reduced, two Kirschner wires were inserted from the lateral side to the sustentaculum to sustain the reduced joint surface. Then another two Kirschner wires were introduced from the tuberosity to the anterior part of calcaneus in different directions to fix the primary and

secondary fracture line. After the closed reduction and provisional fixation were done, the Kirschner wires were replaced by 6.5- and 3.5-mm cannulated screws percutaneously guided by fluoroscopy. The CSC (Wright Medical Technology, Arlington, TN) was placed into the delivery syringe. The delivery needle was advanced through the channel made by the original Schanz pin under fluoroscopic guidance into the bone void in the body created after the reduction. The cement was then slowly and carefully injected into the bone void under fluoroscopic

guidance while the needle was gradually withdrawn. If the surgeon felt resistance, the injection was stopped to prevent the cement from entering the subtalar joint through the fracture line.

Open Reduction and Internal Fixation (ORIF)

through an extensile lateral approach

OR(IF)

ELA

The reduction was accomplished under direct visualization. The fracture was fixed with a combination of screws and a calcaneal plate. The wound was sutured carefully with a suction drain. The

intraoperative blood loss and postoperative wound blood loss were calculated.

Length of follow-up:

24 (range 18 – 30) months

Loss-to-follow-up:

It was stated that 12 patients were lost to follow-up. These patients were excluded from the analysis

Böhler’s angle, mean

Postoperative

PR + CSC: 32.1

ORIF, ELA: 30.6

MD: unclear (no SD)

AOFAS-score, mean

Postoperative

PR + CSC: 91.7

ORIF, ELA: 85.8

MD: unclear (no SD)

Complications

Infection

PR + CSC: 1/38 (2.6%)

ORIF, ELA: 5/40 (12.5%)

RR: 0.21 (95% CI: 0.03, 1.72)

Author’s conclusion: “compared with ORIF, the percutaneous reduction, fixation and CSC grafting for treatment of DIACF might allow accelerated weight bearing activity, reduce joint stiffness and improve the patients’ satisfaction.”

Sampath Kumar, 2014

(from Shi 2020)

Type of study:

RCT

Setting and country:

Tertiary care centre, India, 2010-2011

Funding and conflicts of interest:

None

Inclusion criteria:

- Displaced intra-articular calcaneal fracture – evident on radiographs

- reporting within 3 weeks of injury

Exclusion criteria:

- open wound, peripheral vascular disease, skin infection, signs of compartment syndrome,

- patients with neurologic deficit following head injury or spinal injury

- patients with fractures involving other bones of the lower limb

N total at baseline:

MIRPF: 22

ORIF: 23

Important prognostic factors²:

age ± SD:

MIRPF: 31.5 ± 11.71

ORIF: 30.7 ± 10.07

Sex: M/F

MIRPF:  17/5

ORIF: 18/5

Sanders Type II/III/IV (%)

MIRPF:  8.7 / 43.5 / 47.8

ORIF: 31.8 / 40.9 / 27.3

Groups comparable at baseline?

Probably yes

Minimally invasive reduction and percutaneous fixation (MIRPF) The procedure involved disimpaction of fracture fragments with a Steinmann pin inserted mediolaterally from the posteroinferior part of the medial calcaneal tuberosity.

Traction was applied along the long axis of the foot, with alternating varus and valgus stress to disimpact fracture fragments. In joint-depression fractures, a stab incision was made in the sole of the foot, and a bone punch was advanced through the primary fracture line into the body of the calcaneus under image guidance. In cases in which bone punch could not be negotiated through the body, a pilot track was drilled over a guidewire placed beneath the depressed fragment under image guidance. The bone punch was inserted into this tract and the depressed fragment elevated by gentle blows of a mallet. Care was taken to avoid entering the subtalar joint. In tongue-type fractures, a Steinmann pin inserted lateral to the Achilles tendon into the tuberosity

fragment was used to lever and elevate the displaced fragment. In complex fractures, both techniques were combined as necessary. If reduction was not anatomical after all

possible manoeuvres, the procedure was converted to the open method. If reduction was anatomical, the heelwas compressed

manually to lock the reduced fragments in position. Temporary fixation was achieved using K-wires or guidewires. Cannulated cancellous screws (4 mm) were used

for fragment fixation. A minimum of three screws was used for fixation: two running in the posteroanterior direction and the third running lateral to medial, lying just below the posterior facet in the lateral view and engaging the sustentaculum

tali in the axial view. Care was taken to avoid intra-articular screw placement. Additional screws were placed as necessary.

Open reduction and internal fixation (ORIF) Open reduction was performed using a modified

lateral approach with an L-shaped incision; skin subcutaneous tissue and periosteum were raised as a single, thick flap. K-wires were placed in lateral malleolus, talus and cuboid positions and bent to act as curved retractors. Peroneal

tendons were elevated off the peroneal tubercle and reflected dorsally, while the calcaneofibular ligament was detached from the calcaneus. After subtalar capsulotomy, the entire

lateral calcaneus, including the anterior process that forms the calcaneocuboid joint, was exposed, as necessary. The lateral wall of the calcaneus was then opened like a window to allow access to the articular fragment. Any varus/ valgus

deformity of the heel was corrected. Calcaneus length was restored to normal by traction. Fragments were reduced carefully and temporarily fixed using K-wires. Immense care was taken to reconstruct the articular surface, especially of the posterior facet. Autologous bone graft from the iliac crest was used when considered necessary, without adding antibiotics.

The lateral wall of the calcaneus was reduced, and a calcaneal locking plate was used for fracture fixation after satisfactory reduction, and locking screws were applied. Additional screws were applied as necessary. Hemostasis was achieved, and the wound was closed over a suction drain.

Length of follow-up:

Patients were followed-up at 1.5, 3, 6 and 12 months postoperatively

Loss-to-follow-up:

MIRPF: n = 1

ORIF: n = 2

Böhler’s angle, mean ± SD

Improvement in Böhler’s angle

MIRPF: 18.1 ± 5.4

ORIF: 17.5 ± 6.5

P-value 0.734

Complications

Infection

MIRPF: 4/22 (31.8%)

ORIF: 0/23 (0%)

Wound healing problems

MIRPF: 0/22 (0%)

ORIF: 7/23 (30.4%)

P-value 0.005

Author’s conclusion: “minimally invasive reduction and percutaneous fixation is associated with fewer wound-healing problems, better functional outcome and earlier return to work, compared with ORIF”

Bilateral fractures were included and randomization was done separately for each calcaneal fracture

Lu 2015

(from Shi 2020)

Type of study:

RCT

Setting and country:

China, July 2012 and July 2014

Funding and conflicts of interest:

None

Inclusion criteria:

· cases conforming to the diagnostic criteria for calcaneal fracture;

· Closed fracture within two weeks;

· CT scan and X-ray examination confirmed Sanders II and Sanders III fractures or compression fracture and tongue type fracture classified by Essex-Lopresti system

Exclusion criteria:

· patients of age <18 or >65 years

· simple non-displaced calcaneal fractures

· severe collapsed comminuted fractures

· patients with severe liver and kidney disorders

· psychiatric disorders or accompanied with other severe trauma and open fractures

N total at baseline: n = 96 patients

PRF: 48 (n=62 feet)

ORIF: 48 (n=58 feet)

Important prognostic factors²:

age ± SD

PRF: 45.12 ± 5.16 years

ORIF, ELA: 43.25 ± 4.26 years

Sex:

PRF: 75% M

ORIF, ELA: 79.2% M

Sanders type II/III fracture

PRF: 37/25 feet

ORIF, ELA: 34/24 feet  

Groups comparable at baseline?

Probably yes

Minimally invasive manipulative reduction using percutaneous poking K-wire fixation (manipulation group, PRF)

The procedures were performed with the patients being in lateral decubitus position under spinal anesthesia. Guided by fluoroscopy, the first K-wire was inserted from the superior external side of the calcaneal tuberosity and advanced to the forefoot without crossing the fracture line. With the forefoot in dorsiflexion position, the K-wire was pulled and poked towards the plantar, and reduction was performed to allow for calcaneal inversion and

eversion, as well as flexion and extension of the ankle. Fluoroscopy confirmed that Böhler’s angle was restored within the range of 25°-40° and the length and height of the calcaneus were restored. The K-wire was inserted into the talus after

restoring the subtalar joint surface. A second K-wire was inserted at 1-2 cm inferior to the first K-wire and in the direction parallel to the inferior of the calcaneus, for fracture fragments stabilization

as well as fixation and support between the tarlus and the calcaneus. The heel was squeezed to reduce the calcaneal width. Finally, the fixation was completed by inserting a third K-wire from the posterior of the calcaneus, traversing the fractured fragments of the subtalar joint and reaching the tarsal bones. Lateral fluoroscopic view demonstrated that the three K-wires formed a ≠ structure. The external end of K-wire was trimmed to 1cm.

ORIF (plate group, ELA)

The surgery was performed with patients being in lateral decubitus position under spinal anesthesia. After sterilization, a lateral L-shaped incision was made on the affected foot followed by fracture reduction. Bone grafting was performed if required. Internal fixation was performed using a calcaneal plate (Smith & Nephew, Memphis, TN, USA). Subsequently, a drainage tube was placed, incision was then closed and cast immobilization was performed.

Length of follow-up:

Follow-up at 6 months

Complications, n (%)

Unstable internal fixation

PRF: 4/48 (8.33)

ORIF: 0/48 (0)

Neural and vascular injuries

PRF: 0/48 (0)

ORIF: 5/48 (10.4)

Unfavorable healing

PRF: 2/48 (4.17)

ORIF: 16/48 (33.3)

Author’s conclusion: “lower incidence of adverse reactions and surgical complications was achieved using minimally manipulative reduction with poking k-wire reduction (PRF).”

Manipulative reduction

with poking k-wire fixation is suitable for the treatment of Sanders type II tongue type fracture and compression fracture as well as Sanders type III tongue type fracture, with lower cost, rapid

recovery and smaller wound. This approach can be employed in clinical practice when surgical indications are met.

Giray Batıbay 2020

Type of study:

RCT

Setting and country:

Turkey, January 2017 and February 2018

Funding and conflicts of interest:

None

Inclusion criteria:

· Patients aged >18

years with a minimum one-year follow-up

· Unilateral and acute calcaneus fractures

Exclusion criteria: 

Patients with

· Diabetes mellitus

· Osteoporosis (T-score <-2.5)

·A history of osteoporosis drug therapy

· Previous ipsilateral foot surgery or fracture

· Chronic fracture

· Open fracture

N total at baseline: n = 35 patients

PRF: n = 17

ELA: n = 18

Important prognostic factors²:

For example

age ± SD

PRF: 40.2 ± 10 years

ELA: 39.2 ± 9 years

Sex:

62.9% M

Information not available per treatment group

Groups comparable at baseline?

Probably yes

PRF This procedure

was performed using regional anesthesia without using a tourniquet. The patients were placed in the lateral decubitus position with the injured foot placed on a leg holder in an upper and strictly horizontal position. A free approach to the whole foot was

essential to mount the distraction device appropriately and position the fluoroscope optimally. Two Kirschner (K)-wires were used for distraction, with the first pin inserted in the anterior process of the talus and second pin inserted in the distal plantar region of the tuber calcaneus. The entry points of the pins were marked using the lateral view. After manual correction of the varus with distraction, distraction was applied using the lateral and axial views until an adequate length reduction was achieved. As indicated by the bending of K-wires, significant traction was needed to successfully reduce the fractures. We used an angle-stable, single-point distraction device on the medial side. The tension in the foot ligaments (particularly the plantar fascia) can help raise the longitudinal arch through ligamentotaxis as the calcaneal length is restored. For the fixation of

the axis, length and height, two 6.5-mm cannulated

fully threaded screws were used (Figure 2b). Parallel

screws in the central zone can be considered beams supporting the fractured joint fragments above. Local soft-tissue complications significantly reduced with the use of an entry point above the upper border of the Achilles tendon insertion. Reduction of the central joint fragments of the posterior facet was achieved with the

lift. Kirschner wires were inserted for the preparation for the insertion of 4.0-mm sustentaculum screws. All patients were evaluated postoperatively with CT.

ELA This approach was used under regional anesthesia using a tourniquet. The patients were placed in the supine position, and an incision was performed starting 2 cm above the lateral malleolus parallel to the Achilles tendon at the posterior sural nerve continuing distally towards the sole of the foot. Then, the incision was turned anteriorly and continued at the junction between the lateral dorsal normal skin and plantar skin until the calcaneocuboid joint; thereafter, a dorsal turn of 1 cm was performed. The whole layer of the skin flap was separated to fully

expose the lateral wall of the calcaneus, subtalar joint

and calcaneocuboid joint. A K-wire was drilled to restore the articular surface and fracture reduction. An artificial bone was used to fill the bone defects. When the reduction was satisfactory, as observed by

fluoroscopy, a steel plate was inserted for ORIF. The

fracture end, calcaneal plate and screw location were confirmed using fluoroscopy

Length of follow-up:

PRF: 23.2 months

ELA: 25.3 months

Loss-to-follow-up:

None, patients without at least one year follow-up were excluded

Böhler’s angle, mean ± SD

Preoperative

PRF: 11.2 ± 5

ELA: 13.1 ± 6.1

P-value 0.41

Postoperative

PRF: 26 ± 6

ELA: 28.2 ± 5.2

P-value 0.12

AOFAS, mean ± SD

6 months follow-up

PRF: 90 ± 2.8

ELA: 78 ± 6.3

P-value <0.001

Complications

Peroneal tendinopathy

PRF: 2/17

ELA: 10/18

P-value 0.01

Wound complications

PRF: 0/17

ELA: 3/18

P-value 0.03

Authors conclusion: “Closed reduction using dual-point distraction can be preferred owing to many advantages including a considerably decreased risk of wound complications, sickness absence period and length of hospital stay as well as superior postoperative rehabilitation with a

low pain score.”

Limitations:

· Small sample size

· Only 24 months of follow-up. Longer follow-up is needed to assess arthritic changes in the subtalar joint, which are the most common complications.

· Patient-specific covariates such as smoking habit and medical comorbidities were not evaluated

Li 2020

Type of study:

RCT

Setting and country:

China, trauma center, July 2015 to December 2018

Funding and conflicts of interest:

No conflicts of interest. Information about funding not reported.

Inclusion criteria:

· 18-60 years old

· with unilateral, closed intra-articular calcaneal fractures displaced >2 mm

· with Sanders type II, III, or IV fractures according to CT scans

· Patients accepting the treatment plan designated using a random number table

Exclusion criteria: 

· Patients with previous his­tory of calcaneal fracture

· Other fractures in addition to DIACFs

· Long-term smoking and diabetes

· Patients who were followed up for <12 months

N total at baseline: n = 59 patients

Group A: n = 31

Group B: n = 28

Important prognostic factors²:

age ± SD

Group A: 39.3 ± 9.6 years

Group B: 39.1 ± 8.6 years

Sex M/F (n):

Group A: 24/7

Group B: 21/7

Sanders type II/III/IV (n):

Group A: 9/13/9

Group B: 8/11/9

Groups comparable at baseline?

Probably yes

Percutane­ous reduction and hollow screw fixation (PRHCF, group A)

One 3.5-mm Steinmann pin was first inserted at the calcane­al tubercle transversely from the medial to lateral sides and was used as the traction pin. The pin was then pulled along the axis of the posterior part of the calcaneus to primarily re­store the height and length. Another 3.5-mm Steinmann pin was introduced from the superoposterior portion of the cal­caneus into the fracture fragment along its axis to reduce the posterior facet. The pin tip was placed on the major fracture fragment and not beyond the fracture line. Subsequently, the surgeon performed repeated percutaneous leverage by using the pins inserted sagittally through the calcaneus fragment. The reduction was assessed under fluoroscopic control. If sat­isfactory reduction could not be achieved after repeated lever­age, a 0.3-cm stab incision was made at the bottom side of the calcaneus below the lateral malleolus. The top of the vascular forceps or a 3.5-mm Kirchner wire was placed under the col­lapsed articular bone, which was pulled up to correct the an­gular malformation of the calcaneus and reduce the collapsed articular surface. Thereafter, the calcaneal width was restored by manually squeezing the surface of both sides of the calca­neal bone, and the 2.0-mm Kirchner wire was used for tempo­rary fixation. After satisfactory reduction confirmed using the C-arm fluoroscopy intensifier, a guide pin was inserted adja­cent to the lateral edge of the Achilles tendon from the super­oposterior portion of the calcaneal tubercle to the distal part of the fracture. Another guide needle was inserted percuta­neously from the site 0.5 cm below the insertion point of the Achilles tendon across the fracture line to the anterior part of the calcaneus. After the satisfactory position of the guide pin was confirmed radiologically, a 6.5-mm diameter hollow screw was inserted to achieve the axial support fixation of the cal­caneus. If the fracture of the lateral wall of the calcaneus ex­panded outwards, 1 to 3 guide pins were inserted percuta­neously at the bone block of the lateral side of the calcaneus below the lateral malleolus, and a 4.0-mm hollow screw was inserted to maintain the calcaneal width. Gaskets were used for incomplete bone block.

ORIF with ELA, group B

A curvilinear, L-shaped inci­sion was made at the affected foot. Once the lateral wall of the calcaneus and the subtalar joints were exposed, the full-thick­ness flap was held in place with three 2.0-mm Kirschner wires (1 each in the fibula, talar neck, and navicular). A Steinmann pin or traction bow was used for reducing the displaced artic­ular surface to allow restoration of the calcaneal shape. After satisfactory reduction, a lateral plate designed for the calcane­us was generally used for rigid fixation. The rubber drains were then inserted into the incision, and the incision was closed in a layered fashion followed by compression bandaging.

Length of follow-up:

Patients were seen for follow-up at one, 3, 6, and 12 months postoperatively and then yearly thereafter.

Loss-to-follow-up:

No loss-to-follow-up, since patients who were followed-up for <12 months were excluded from the analysis

Böhler’s angle, mean ± SD

Preoperative

Group A: 10.1 ± 1.7

Group B: 10.4 ± 1.2

P value 0.428

Postoperative

Group A: 30.2 ± 2.1

Group B: 30.7 ± 1.2

P value 0.261

AOFAS hindfoot score, mean

Postoperative

Group A: 88.3

Group B: 86.4

P value 0.08

MD unclear, since SDs were not reported

Soft tissue complications, n (%)

Total

Group A: 1/31 (3.2)

Group B: 3/28 (10.8)

P value 0.337

OR=0.28 (95% CI, 0.03;2.84)

Superficial infection

Group A: 1/31 (3.2)

Group B: 1/28 (3.6)

Deep infection

Group A: 0/31 (0)

Group B: 1/28 (3.6)

Wound edge necrosis

Group A: 0/31 (0)

Group B: 1/28 (3.6)

Sural nerve injury

Group A: 0/31 (0)

Group B: 0/28 (0)

Author’s conclusion: “

Percutaneous reduction and hollow screw fixation can achieve comparable reduction and functional outcomes to ORIF in treat­ing DIACFs. Percutaneous reduction and hollow screw fixa­tion can minimize damage to the surrounding tissues, which can subsequently result in shorter operative time and hospi­tal stay, and reduced intraoperative blood loss, postoperative pain, and complication rates. Therefore, percutaneous reduc­tion and hollow screw fixation is a safe and effective treat­ment choice for DIACFs, and a further randomized controlled trial with a larger sample size is warranted”

Limitations

· Small sample size

· Differences in surgeons’ performances might have decreased the ability to extrapolate the results of this study

· Validated PROMs were not included in initial study design

Vora 2022

Type of study:

RCT

Setting and country:

Hospital in India, December 2017 to September 2019

Funding and conflicts of interest:

No information

Inclusion criteria:

· 16-75 years old

· Reporting to the Orthopedics OPD/casualty section with closed DICF

· with >2 mm displacement, as per Essex Lopresti classification

Exclusion criteria: 

· Patients with pathological fractures

· Gustilo grade III open fracture

· neurological deficits

N total at baseline: n = 30 patients

Group P: n = 15

Group O: n = 15

Important prognostic factors²:

age ± SD

Group P: 41 ± 11.70 years

Group O: 41.4 ± 11.25 years

Sex M/F (n):

Group P: 12/3

Group O: 12/3

Joint depression/tongue type fracture (n):

Group P: 7/8

Group O: 8/7

Groups comparable at baseline?

Yes, but not for hospitalization duration

Percutaneous surgery (PS, group P) The patients were treated with closed reduction (PS) using the Essex Lopresti technique. Patients were placed prone on an operating table with their foot protruding. To

achieve reduction, one or two ST pins were inserted from the calcaneal tuberosity towards the

subtalar joint, under image intensifier control. Stress over the axis was given onto the pins down the distal side to correct Bohler’s angle. Final

fixation and stabilization were done using Steinman

pins alone or K wires with percutaneous screws.

ORIF with plating, using the lateral universal approach of calcaneum, group O The patients were placed in a lateral

decubitus position on a radiolucent operating table,

with the foot elevated on an appropriate support. A

full-thickness, L-shaped, lateral incision was made,

with a gentle curve between the two segments. The

fracture was reduced and temporarily fixed with K-wires under radiographic guidance. Various types of calcaneal plates like simple reconstruction plates, Y-reconstruction plates, H-plates and anatomical calcaneal plates were used for final stabilization.

Length of follow-up:

Patients were seen for follow-up at 6 weeks, 2 months, 3 months and 6 months postoperatively

Loss-to-follow-up:

Not reported

Böhler’s angle, mean ± SD

Preoperative

Group P: 8.73 ± 4.94

Group O: 5.93 ± 4.98

P value 0.1331

6 months postoperative

Group P: 22 ± 3.72

Group O: 28.47 ± 7.20

P value 0.0056

AOFAS hindfoot score, mean ± SD

6 months postoperative

Group P: 78.53 ± 8.98

Group O: 87.73 ± 5.46

P value 0.0021

Complications, n (%)

Infection

Group P: 1/15 (6.67)

Group O: 3/15 (20)

P value 0.5957

Wound dehiscence

Group P: 0/15 (0)

Group O: 4/15 (26.67)

P value 0.1004

Malunion, n (%)

Group P: 6/15 (40)

Group O: 3/15 (20)

P value 0.4138

Author’s conclusion “ORIF was found to be associated with

better functional and radiological outcomes

compared to PS”

Limitations

Single center approach with small sample size

Zhai 2021

Type of study:

RCT

Setting and country:

Hospital in China, April 2015 to April 2019

Funding and conflicts of interest:

No information about funding, no conflicts of interest

Inclusion criteria:

· Patients with fresh, closed, calcaneus fracture

· Patients who underwent the regular X-ray examination, computed tomography (CT) scanning and 3-dimensional reconstruction

· Patients who took the symptomatic treatment, including fixation, raising and detumescence of affected limb, and active treatment for the complications of fracture

Exclusion criteria: 

· Patients with open fracture, or dated fracture

· Patients with ankle fracture or tarsal fracture

· Patients with the history of ankle injury

· Patients with the ankle dysfunction in the affected limb prior to the fracture

· Patients with the pathological fracture due to the primary osteogenic tumor, osteoid lesion, cystic pathogenic damage, or bone metastases

· Patients with diseases in nervous system or mental disease.

N total at baseline: n = 60 patients

Group A: n = 30 (32 feet)

Group B: n = 30  (31 feet)

Important prognostic factors²:

age ± SD

Group A: 36.85 ± 7.42 years

Group B: 37.26 ± 7.38 years

Sex M/F (n):

Group A: 21/9

Group B: 23/7

Sanders fracture type II/III (n):

Group A: 19/11

Group B: 18/12

Groups comparable at baseline?

Yes

closed reduction with hollow screw internal fixation, group A Patients were anesthetized in supine position by the combined spinal and epidural analgesia, followed by the sanitization and draping and surgical treatment under the C-type arm. Punctuating point and direction were selected upon the preoperative X-ray examination and CT examination. From the posterior and lower calcaneal tuberosity, a 4.0 Steinmann pin was drilled vertically and flipped to tract to correct the varus and shortening of calcaneus. Then, under the guidance of C-type arm, a guide pin was inserted percutaneously from the calcaneus tuberosity to fix the site of fracture. Later, in the lateral side of the Achilles tendon, a Steinmann pin was drilled on the top of the calcaneal tuberosity, where the pin tip was advanced to the fracture space and then lifted up to support the bone on the articular surface to correct the Bohler angle and Gissane angle, while the bone at the fracture site was fixed by the 1 or 2 pins drilled beneath the lifted pin. Otherwise, 1 or 2 cannulated screws were inserted along the pin, and the pin was then taken out, followed by suture and plaster external fixation.

Surgical open reduction and internal fixation of irregular steel plates, group B Patients were anesthetized in lateral position of the non-affected side by the combined spinal and epidural analgesia. An L-shape incision was made on the lateral calcaneus and in the middle of Achilles's tendon and fibula and the boundary between the dorsal and pedis of foot skin, a longitudinal and horizontal incision was made respectively. Then, the incision of the calcaneocuboid joint slightly leaned against the dorsal side. During the surgery, incision should reach the surface of bone, where the electrotome was only suggested for hemostasis. To expose the tendon of peroneus longus, the tissues from the skin to the periosteal flap were flicked over, and then 3 kirschner wires were inserted into the astragalus to fix the flaps. Thereafter, paries lateralis was open to expose the lower joint surface which was then turned over by 90°, and then the sclerites in collapse were poked to restore the Gissane angle. The middle to lower joint surface, if necessary, could be exposed by removing the fat in the tarsal canal, while since the anterior to the lower joint surface was hardly to be exposed, a kirschner wire was inserted transversely through the calcaneus tuberosity and dragged downwards to restore the Bohler angle. Thereafter, along the calcaneal axis, a kirschner wire was used to poke to restore the calcaneus height and then inserted directly into the astragalus for restoration and to widen the calcaneus by suppressing longitudinally the paries lateralis of calcaneus. Under the C-shape arm, Bohler angle was adjusted to 30° and after the joint restoration, the artificial bone or iliac bone was inserted in the space of calcaneus according to the defect of subarticular surface bone. A suitable, plastic plate was placed on the paries lateralis of calcaneus, where the screw should be inserted into the sustentaculum tali. Finally, the kirschner wires were taken out, with the thorough hemostasis and a drainage tube was inserted, followed by the suture and compressed dressing.

Length of follow-up:

All patients were followed up for 3-15 months, average follow-up 10.15 ± 2.67 months

Loss-to-follow-up:

Not reported

Böhler’s angle, mean ± SD

Preoperative

Group A: 14.19 ± 2.47

Group B: 14.08 ± 2.35

P value 0.857

3 months postoperative

Group A: 33.52 ± 4.41

Group B: 33.09 ± 4.36

P value 0.0056

Complications, n (%)

Nerve damage

Group A: 0/32 (0)

Group B: 0/31 (0)

Superficial wound infection

Group A: 1/32 (3.13)

Group B: 3/31 10.0)

Deep infection

Group A: 0/32 (0)

Group B: 1/31 (3.23)

Marginal necrosis of skin

Group A: 0/32 (0)

Group B: 3/31 (10.0)

Subtalar arthritis, n (%)

Group A: 2/32 (6.25)

Group B: 0/31 (0)

Author’s conclusion: “closed replacement and internal fixation of cannulated screw and surgical open reduction and internal fixation of irregular steel plates can both gain promising outcomes in terms of the replacement and postoperative recovery of foot function for calcaneal fracture, while the former is excellent in the mild surgical trauma and low incidence of postoperative complications.”

Limitations

Small sample size

No information about loss-to-follow-up

PICO B: STA vs ELA

Park 2021

Type of study:

RCT

Setting and country:

Single centre, South-Korea, 2013 to 2018

Funding and conflicts of interest:

None, non-commercial grant.

Inclusion criteria:

- adult patients aged > 18 years

- Sanders type 2A and 2B calcaneal fracture

- surgery by a single surgeon

- follow-up of patients > 1year

Exclusion criteria:

- open calcaneal fracture

- bilateral intra-articular calcaneal fracture

- Sanders Type 1, 2C, 3 and 4

- concomitant head or neurovascular injury

N total at baseline:

STA: 32

ELA: 32

Important prognostic factors²:

age ± SD:

STA: 50.4 ± 13.9

ELA: 48.8 ± 11.9

Sex: M/F

STA:  28/4

ELA: 29/3

Only Sanders type II included.

Groups comparable at baseline?

Probably yes

Sinus Tarsi Approach (STA)

A 4 cm incision was made from the tip of the lateral malleolus to the level of the

calcaneum joint toward the fifth metatarsal. After exposing the fracture site, the impacted posterolateral fragment was elevated

using a curette. Calcaneal alignment and height were restored by valgus and downward stress using the Steinmann pin that was inserted into the calcaneal tuberosity. Calcaneal width was restored by compressing the heel by applying force to the lateral

aspect. After reducing the posterolateral fragment, Kirschner wires were temporarily fixed to the medial fragment and definite fixation of the posterolateral fragment was performed using two 2.7 mm cortical screws. Fixation between the anterior process and posterior facet fragment was then performed using two or three 7.0 mm cannulated screws.

Extensile lateral approach (ELA)

A vertical limb incision was made along the lateral

edge of the Achilles tendon and a horizontal limb incision was made along the junction of plantar skin and skin of lateral aspect of the foot skin. The lateral wall was retracted inferiorly to expose the fracture site. After reducing the posterolateral fragment, fixation of the posterolateral fragment was performed using two 2.7 mm cortical screws. After restoration of the length

and height of the calcaneus, a calcaneal locking plate (DePuy Synthes, West Chester, Pennsylvania, USA) was applied to stabilize the anterior process and posterior facet fragment).

Length of follow-up:

Follow-up at 6 and 12 months

Loss-to-follow-up:

STA: n = 0

ELA: n = 0

Böhler’s angle, mean ± SD

STA: 21 ± 7.4

ELA: 21 ± 6.4

AOFAS-score, mean ± SD

12 months follow-up

STA: 90.3 ±  9.8

ELA: 87.3 ± 8.7

Complications, n (%)

Wound complications:

STA: 0/32 (0)

ELA: 4/32 (12.5)

Sural Nerve injury

STA: 1/32 (3.1)

ELA: 3/32 (9.4)

Author’s conclusion: “The extensile lateral approach showed higher frequency

of wound complications than the sinus tarsi approach for

Sanders type 2 calcaneus fractures, even though there was no statistical significance.

-- The sinus tarsi approach showed better short-term

clinical results and

shorter operation time than the extensile lateral approach.”

Wound complications included minor and major complications. Minor complications: superficial infections and superficial marginal wound necroses that could be managed without reoperation or with small procedures (minor injuries).

Major complications: deep infection and deep marginal wound necrosis involving the implants and the bones requiring reoperation.

Rastegar 2021

Type of study:

RCT

Setting and country:

Two centres in Iran, in 2019

Funding and conflicts of interest:

None

Inclusion criteria:

- patients aged 18 - 75

- intra-articular fracture of the calcaneus with a displacement (more than 2 mm)

Exclusion criteria:

- previous history of surgery, osteoarthritis, and inflammatory arthritis in the foot and ipsilateral ankle, absence of major comorbidities, smoking

- patients with fractures due to secondary causes at the operation site

N total at baseline: n = 30

STA: 15

ELA: 15

Important prognostic factors²:

age ± SD:

STA: 41.6 ± 7.5

ELA: 35.3 ± 11.7

Sex: M/F

STA:  11/4

ELA: 12/3

Groups comparable at baseline?

Probably yes

STA

Minimally invasive technique

The patient was placed in a lateral position. The tourniquet was closed above the ankle and left on for up to 2 hours. The incision was given from the site of the lat­eral malleolus to the base of the fourth meta­tarsus. With the help of this method, posterior facet and, if necessary, anterior and calcaneo­cuboid joint facets could be seen and reduced.

Extensile lateral approach (ELA)

In the second group, the patient was placed in the lateral position. The tourniquet was closed above the ankle and left on for up to 2 hours. The patient underwent surgery using a large L-shaped incision in the lateral ankle according to Benirshcke and Sangeorzan methods. All sur­geries were performed by a single orthopedic surgeon and the same surgical team.

Length of follow-up:

Follow-up at 3, 6, and 12 months

Loss-to-follow-up:

None, patients without adequate follow-up at 12 months were excluded

Böhler’s angle, mean ± SD

STA: 48.73 ± 7.9

ELA: 40.45 ± 5.59

Complications, n (%)

Soft tissue complications

STA: 3/15 (20)

ELA: 10/15 (66.7)

Author’s conclusion:

“The extensile approach

was associated with lower pain, lower Boehler angle and better quality of reduction compared to minimally invasive technique but also

higher operation duration and surgical site complication”

The incidence of soft tissue complications such as surgical site infection, surgical

wound dehiscence, bread union or delayed union, erythema or cellulitis were recorded by the orthopedic surgeon during 12 months of

follow-up.

Zhang 2020

Type of study:

RCT

Setting and country:

Single Centra, China, 2017 to 2019

Funding and conflicts of interest:

None

Inclusion criteria:

- patients with Sanders types II and III intra-articular calcaneal fracture

- closed fractures

- single foot

Exclusion criteria:

- extra-articular calcaneal fractures,

- Sanders type IV

- surgical contraindications

- foot deformities

- congenital diseases

- abnormal foot function

N total at baseline: n = 106

STA: 53

ELA: 53

Important prognostic factors²:

age ± SD

total population: 41.57 ± 2.63, 24-58 years

Sex: M/F

In total: 59/47

Sanders type II/III fractures

Total population

55 cases type II

51 cases type III

Groups comparable at baseline?

Probably yes

Tarsal sinus approach (group A, STA)

That is, an incision about 3 cm long was cut along the long axis of fibula, 1-2 cm below the ankle in order to expose the tarsal sinus, and then the fracture site was adjusted using a Steinmann pin. After that, the fracture site was fixed temporarily using 2-3 Kirschner wires. The calcaneus was repositioned by manipulation, and after the reposition standard was met, a hollow screw was inserted into the tarsal sinus for fixation.

Lateral Extended approach (group B, ELA)

That is, the standard surgical method of lateral incision was used, the skin of the foot was cut open to the heel, about 1 cm above the junction between the instep and sole, the periosteum was stripped, the frac­tured end of calcaneus was opened and reposi­tioned using a medical stripper. The articular surface was observed using X-ray. When the reposition standard was met, the fracture site was fixed with a medical screw and a medical steel plate.

Length of follow-up:

Follow-up at 6 months

Loss-to-follow-up:

None, patients without adequate follow-up at 6 months were excluded

Böhler’s angle, mean ± SD

STA: 26.8 ± 2.2

ELA: 26.3 ± 2.3

P value 0.316

AOFAS hindfoot score, mean ± SD

6 months follow-up

STA: 85.7 ± 3.9

ELA: 84.3 ± 4.6

P value 0.108

Complications, n (%)

Wound infection:

STA: 1/53 (1.9)

ELA: 4/53 (7.6)

Nerve injury

STA: 0/53 (0)

ELA: 1/53 (1.9)

Delayed union

STA: 1/53 (1.9%)

ELA: 2/53 (3.8%)

Author’s conclusion: “both surgeries via the tarsal sinus approach and the lateral extended approach have a good efficacy on intra-articular calcaneal fracture. However, compared with the lateral extended approach, the tarsal sinus approach has less intraoperative blood loss, shorter getting out-of-bed time, shorter length of stay and fewer postoperative complications.”

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Hussain 2022 PICO A

Probably yes;

Reason: it was stated that computer generated random number tables were used

No information on allocation concealment

Probably no;

Reason: no information, however due to the nature of the intervention blinding is unlikely

Probably yes

Reason: there were no patients reported to be lost to follow-up

Probably yes;

Reason: outcomes stated in the method section were reported

Probably no;

Reason: it is not clear if the intervention and control group had similar baseline characteristics as Böhlers Angle in the healthy foot was 31.01 versus 25 degrees respectively

Some concerns for the outcomes Bohlers angle

STA vs ELA

Chen 2011 (from Shi 2020 ) PICO B

No information on allocation sequence generation (but it was stated that patients were randomly assigned)

No information on allocation concealment

Probably no;

Reason: it was stated that examinations were blinded as participants were not directly involved with the care of patients in either group. Additional information on blinding  procedures was not provided

Probably yes

Reason: 12 patients were lost to follow-up, these were excluded from the analysis. Not clear from which group.

Probably yes;

Reason: outcomes stated in the method section were reported

Probably yes;

Reason: no other sources of bias could be identified

Some concerns for all outcomes

Unclear randomization and blinding procedure

Sampath Kumar 2014 (from Shi, 2020)

PICO B

Definitely yes;

Reason: randomisation by lottery method

No information

Definitely no

Reason: it was stated that blinding methods were not feasible

Probably yes

Reason: Loss to follow-up was infrequent in intervention and control group (n =1 and n = 2)

Definitely yes

Reason: outcomes stated in the method section were reported

Probably no

Reason: bilateral fractures were included. Infection occurred in three fractures from two patients

Some concerns for functional outcome

High for infection.

Lu 2015 (from Shi, 2020)

PICO B

No information on allocation sequence generation (but it was stated that patients were randomly divided into two groups)

No information on allocation concealment

Probably no;

Reason: No information, however due the nature of the intervention it is likely that there was no blinding

No information on loss to follow-up

Probably yes;

Reason: outcomes stated in the method section were reported

Probably yes;

Reason: no other sources of bias could be identified

High for all outcomes

Problems with blinding, unclear randomization, unclear loss to follow-up

Giray Batıbay 2020

PICO B

Definitely yes

Reason: A variable block schedule was created on a computer system for randomization

Definitely yes

Reason: The list containing the resulting treatment groups was stored in sealed non-transparent envelopes.

Probably no

Reason: No information, however, due to the nature of the intervention, it is likely that there was no blinding

Definitely yes

Reason: Patients without adequate follow-up were excluded from the study population

Definitely yes

Reason: Outcomes stated in the method section were reported

Definitely yes

Reason: no other sources of bias could be identified

Some concerns for AOFAS (patient-reported outcome)

Low for Böhler’s angle and complications (both hard outcomes)

Problems with blinding

Li 2020

PICO B

Definitely yes

Reason: a random number table was used

No information

Probably yes

Reason: outcomes were assessed by an orthopedic surgeon who was blind to the patient grouping. No information about blinding of patients.

Probably yes

Reason: in total, 12 patients were lost to follow-up and were excluded from the analysis, but not clear from which group. It is likely that 4 patients in group A were excluded and 8 patients in group B (or vice versa), given that 71 patients were enrolled in the study.

Definitely yes

Reason: Outcomes stated in the method section were reported

Definitely yes

Reason: no other sources of bias could be identified

Low for Böhler’s angle and complications

Vora 2022

PICO B

No information

No information

Probably yes

Reason: it was stated that the study was double blind, but given the nature of the intervention, this is questionable.

No information

Definitely yes

Reason: Outcomes stated in the method section were reported

Probably no

Reason: “… double-blind study”, so researcher and patients are blinded, but how is this possible?

High for all outcomes

Outcomes AOFAS hindfoot score, Böhler’s angle, complications

Reason: no information about allocation sequence generation, allocation concealment, loss-to-follow-up

Zhai 2021

PICO B

No information, but it was stated that patients were randomized

No information

No information

No information

Definitely yes

Reason: Outcomes stated in the method section were reported

Definitely yes

Reason: no other sources of bias could be identified

High for all outcomes

Reason: no information about crucial elements to judge RoB (randomization method, allocation concealment, blinding, loss-to-follow-up)

STA vs ELA

Park 2021,

PICO B

No information on allocation sequence generation (but it was stated that patients were randomly assigned)

No information on allocation concealment

Probably no;

Reason: No information, however due the nature of the intervention it is likely that there was no blinding

Probably yes;

Reason: it was stated that no patients were lost to follow-up

Probably yes;

Reason: outcomes stated in the method section were reported

Probably yes;

Reason: no other sources of bias could be identified

Some concerns for all outcomes

Unclear randomization and blinding procedure

Rastegar 2021

PICO B

Definitely yes;

Reason: allocation sequence was generation with random allocation software

No information

Probably no;

Reason: No information, however due the nature of the intervention it is likely that there was no blinding

Probably yes;

Reason: patients without adequate follow-up were excluded from the study population

Definitely no;

Reason: in the method section it is stated that AOFAS and VAS were reported as an outcome, but these were not reported in the result section

Probably yes;

Reason: no other sources of bias could be identified

High for all outcomes

No blinding and selective outcome reporting.

Zhang 2020

PICO B

No information on allocation sequence generation (but it was stated that patients were randomly assigned)

No information on allocation concealment

Probably no;

Reason: No information, however due the nature of the intervention it is likely that there was no blinding

Probably yes;

Reason: patients without adequate follow-up were excluded from the study population

Probably yes;

Reason: outcomes stated in the method section were reported

Probably yes;

Reason: no other sources of bias could be identified

Some concerns outcomes

Unclear randomization and blinding procedure