Totale heupprothese (THP)

Initiatief: NOV Aantal modules: 23

Organisatie van fast-track-behandeling bij THP

Uitgangsvraag

Wanneer is er een indicatie voor fast-track-behandeling en aan welke voorwaarden moet de organisatie voldoen?

Aanbeveling

Een fast-trackprogramma heeft de voorkeur na een totale heupprothese, onder voorwaarde dat er een protocol is waarin is opgenomen:

  • goede voorlichting;
  • opioïdsparend protocol voor anesthesie en pijbestrijding;
  • maatregelen om bloedverlies te beperken (tranexaminezuur);
  • mobilisering op de dag van de operatie;
  • gestandaardiseerde ontslagcriteria (waarin opgenomen ADL);
  • en desgewenst een individueel revalidatietraject.

 

Een fast-track programma dient rekening te houden met fragiele patiënten onder het motto “first better – then faster”.

Overwegingen

Outpatient surgery

The high-volume centre RCT by Goyal, (2017) evaluated 220 patients who had total hip arthroplasty (THA) surgery between July 2014 and September 2015. Patients were randomised between outpatient surgery (discharge planned on the same day as surgery) and inpatient surgery (discharge planned after an overnight stay). Primary endpoints were postoperative pain, peri-operative complications and healthcare provider visits (re-admission A&E or physician’s office) and relative work effort for the surgeon’s office staff. There was no significant difference in pain on the day of surgery and after 4 weeks, but on the first day after surgery outpatients reported more pain than inpatients. After 4 weeks, Harris Hip Scores showed no difference between the two groups. Of the 112 patients randomised to outpatient surgery, 85 (76%) were discharged as planned. Of the remaining 27 patients, 26 were discharged after one night in the hospital and one was discharged after two nights. Of the 108 patients randomised to inpatient surgery, 81 (75%) were discharged as planned. There was no difference in the number of re-operations, hospital re-admissions without re-operation, A&E visits without hospital re-admission, or acute office visits. Goyal (2017) concludes that outpatient THA can be implemented in a defined patient population. Because 24% (27 of 112) of patients planning to have outpatient surgery could not be discharged on the same day, facilities to accommodate an overnight stay should be available Goyal, (2017).

 

The prospective two-centre cohort study of Gromov (2017) reports on the feasibility of outpatient THA (and total knee arthroplasty (TKA)) in unselected (consecutive patients referred to orthopaedic surgeons in a hospital for THP without any selection) patients. Of the 557 patients, 304 were THA and 253 were TKA. Of the 304 THA patients who were referred to the participating surgeons during the study period, 55% were potentially eligible for outpatient surgery. 34 patients were excluded for the reason of living alone. Of the remaining 133 patients, 47 (35%) were discharged on the actual day of surgery Gromov, (2017).

 

Fast track

Jørgensen (2017) describe the results of a prospective observational study in 13,775 consecutive THA (N=6553) and TKA (N=7222) patients with similar fast-track protocols and a median length of stay of 2 days. Of a total of 44 deaths (30 THA/ 14 TKA) (0.3%), 28 (20 THA/ 8 TKA) (0.2%) were found to have a certain or probable relation with surgery and were considered as surgery-related. Surgery-related deaths were more common after THA than TKA (0.3% versus 0.1% P = 0.044), occurred after median 14 days and 19 of 28 were between day 0 to 30. The most common initial organ dysfunction for surgery-related deaths was pulmonary (6/28) and gastro-intestinal (6/28), while the most commonly reported causes of death were pulmonary (9/28) and cardiac events (6/28) Jørgensen (2017).

 

Thrombo-embolic events (TEE) are serious complications after total hip (THA) and knee arthroplasty (TKA), with reported in-hospital incidences of about 0.5 to 1% for venous thrombo-embolic events (VTE) and 0.2% for myocardial infarctions (MI) and stroke with a traditional protocol Jørgensen, (2017).

 

Jørgensen (2016) describe the results of a prospective observational study in 13,775 consecutive THA/TKAs with similar fast-track protocols and a median length of stay (LOS) of two days. "Early" TEEs (within one week of surgery) consisted of 9 (0.07%) MI, 10 (0.08%) strokes, 13 (0.09%) pulmonary embolisms and 11 (0.08%) deep venous thromboses. Jørgensen conclude that the incidence of "early" TEEs after fast-track THA and TKA is low. Improving peri-operative treatment of anaemia may further reduce the number of MIs Jørgensen (2016).

 

Khan (2014) compared two consecutive unselected cohorts of 1,369 THA patients and 1,631 TKA patients with a traditional protocol (2004 to 2008) with 1,256 THAs and 1,744 TKAs with an enhanced recovery protocol (2008 to 2011). The median LOS in the enhanced recovery group was reduced (3 days versus 6 days; p = 0.01). Blood transfusion rate was also reduced (7.6% versus 23%; p <0.001), as was return to theatre rate (p = 0.05). Myocardial infarction at 30 days (0.4 versus 0.9%, p=0.03) and mortality at 30 days (0.2 versus 0.5%, p=0.03) was lower in the enhanced recovery group, mortality at 90 days was not significantly different (0.5 versus 0.8%, p=0.1). Other outcomes showed no significant difference. Khan (2014) conclude that the enhanced recovery programme has achieved a statistically significant reduction in LOS and in cardiac ischaemic events for patients, with a near-significant decrease in return to theatre and in mortality rates.

 

Summarizing

The narrative review by Hansen (2017) summarises literature and provides insights into fast track surgery in THA. Fast track surgery in THA resulted in a reduction in postoperative LOS, shorter convalescence and rapid functional recovery without increased morbidity and mortality. According to Hansen, fast-track THA surgery now works extremely well in the standard THA patient. However, all patients are different and fine-tuning of the multiple areas in fast-track pathways to get patients with special needs or high co-morbidity burden through a safe and effective fast-track THA pathway is important. Hansen provides an overview of possible pre-operative and peri-operative optimisations. These include patient information and teaching, an opioid-sparing pain and anaesthetic protocol and mobilisation on the day of surgery.

 

Another narrative review by Galbraith (2018) concluded that pre-operative education programmes, outpatient consultation, pre-anaesthetic assessment, pre-procedural physiotherapy, day-of-surgery admission, pre-operative medications, type of anaesthesia, blood loss reduction protocols, multimodal analgesia delivery, day-of-surgery mobilisation, thrombo-embolic prophylaxis and ongoing rehabilitation are essential in enhanced recovery. Galbraith also concluded that that the impact of individual variables requires further research.

 

Until recently, the reports of outpatient THA have been anecdotal, single surgeon or single institution based or with selected patient populations. However, two more recent papers by Goyal et al. (2017) and Gromov et al. (2017) report respectively on a multi-centre randomised trial and a multi-centre study with unselected patients (Goyal, 2017; Gromov, 2017). Both studies confirmed the feasibility of outpatient THA, although many challenges need to be overcome before it can be defined as an established treatment option and more widespread use recommended.

 

The published studies on outpatient THA from Europe have all been from institutions that have a well-established fast-track protocol. As a result of their programmes, these hospitals have seen their length of stay gradually decrease to a point where outpatient THA is feasible. For most hospitals, outpatient THA surgery should not be a goal in itself, but should rather be the result of a successful, already implemented fast-track programme based on the concept “first better – then faster.”

Onderbouwing

In the past decades, fast track programmes have successfully been introduced in orthopaedics. A combination of organisational and medical improvements in peri-operative protocols has led to an enhanced recovery of patients after total hip arthroplasty (THA), lowering morbidity and mortality.

No systematic literature review was performed for this question. The recommendations are based on an exploratory search and the expert opinion of the working group.

  1. Galbraith AS, McGloughlin E, Cashman J. Enhanced recovery protocols in total joint arthroplasty: a review of the literature and their implementation. Ir J Med Sci. 2018;187(1):97-109. doi: 10.1007/s11845-017-1641-9. Epub 2017 Jun 16.
  2. Gromov K, Kjærsgaard-Andersen P, Revald P, et al. Feasibility of outpatient total hip and knee arthroplasty in unselected patients. Acta Orthop. 2017;88(5):516-521.
  3. Goyal N, Chen AF, Padgett SE, et al. Randomized Study of Outpatient versus Inpatient Total Hip Arthroplasty. Clin Orthop Relat Res. 2017;475(2):364-372.
  4. Hansen TB. Fast track in hip arthroplasty. EFORT Open Rev. 2017;2(5):179-188.
  5. Jørgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative group. Time course and reasons for 90-day mortality in fast-track hip and knee arthroplasty. Acta Anaesthesiol Scand. 2017;61(4):436-444.
  6. Jørgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee replacement collaborative group. Early thromboembolic events =1week after fast-track total hip and knee arthroplasty. Thromb Res. 2016;138:37-42.
  7. Khan SK, Malviya A, Muller SD, et al. Reduced short-term complications and mortality following Enhanced Recovery primary hip and knee arthroplasty: results from 6,000 consecutive procedures. Acta Orthop. 2014;85(1):26-31.

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 12-02-2019

Laatst geautoriseerd  : 12-02-2019

Geplande herbeoordeling  : 01-01-2024

Module

Party in control

Year of authorization

Next assessment of actuality

Frequency of assessment actuality

Which party/parties monitors actuality

Important factors that might lead to change in recommendations

Fast track

NOV

2018

2023

Every five years

NOV

 

Initiatief en autorisatie

Initiatief:
  • Nederlandse Orthopaedische Vereniging
Geautoriseerd door:
  • Koninklijk Nederlands Genootschap voor Fysiotherapie
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging voor Klinische Geriatrie
  • Nederlandse Vereniging voor Medische Microbiologie

Algemene gegevens

The development of this guideline was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (SKMS; Foundation for Quality Funding for Medical Specialists).

Doel en doelgroep

Aim of the guideline

The main purpose of the guideline is to provide the best possible care to patients with osteoarthritis of the hip, by informing optimal treatment decisions and reducing unwarranted variation in the delivery of care and long-term failure of the implants.

 

Envisaged users of the guideline

This guideline was developed for all Dutch healthcare providers of patients with osteoarthritis of the hip.

Samenstelling werkgroep

This guideline was developed and sponsored by the Netherlands Orthopaedic Association (NOV), using government funding from the Quality Funding for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten in the Netherlands, SKMS). Patient participation was cofinanced by the Quality Funding Patient Consumers (Stichting Kwaliteitsgelden Patiënten Consumenten, SKPC) within the program ‘Quality, insight and efficiency in medical specialist care’ (Kwaliteit, Inzicht en Doelmatigheid in de medisch specialistische Zorg, KIDZ). The early preparative phase started in October 2016. The guideline was officially authorised by the Netherlands Orthopaedic Association on February 12, 2019. Decisions were made by consensus. At the start of guideline development, all working group members completed conflict of interest forms.

 

Members of the guideline development working group

  • Dr. B.A. Swierstra, orthopaedic surgeon, Sint Maartenskliniek, Nijmegen, NOV, Chair
  • Dr. R.H.M. ten Broeke, orthopaedic surgeon, Maastricht University Medical Centre, NOV
  • Drs. P.D. Croughs, medical microbiologist, Erasmus University Medical Center, NVMM
  • Dr. R.A. Faaij, geriatrician, Diakonessen Hospital, Utrecht, NVKG
  • Dr. P.C. Jutte, orthopaedic surgeon, University Medical Center Groningen, NOV
  • D.E. Lopuhaä, policy worker patient advocacy, Dutch Arthritis Society
  • Dr. W.F.H. Peter, physiotherapist, Leiden University Medical Center, KNGF
  • Dr. B.W. Schreurs, orthopaedic surgeon, Radboud University Medical Centre, Nijmegen, NOV
  • Dr. S.B.W. Vehmeijer, orthopaedic surgeon, Reinier de Graaf Hospital, Delft, NOV
  • Dr. A.M.J.S. Vervest, orthopaedic surgeon, Tergooi Hospital, Hilversum, NOV
  • J. Vooijs†, patient with osteoarthritis, National Association ReumaZorg Nederland
  • Drs. G. Willemsen-de Mey, chairperson, National Association ReumaZorg Nederland

 

Readers:

  • S. Nijssen, medical microbiologist, VieCuri Medical Center, Venlo, NVMM
  • R.J. Rentenaar, medical microbiologist, University Medical Center, Utrecht, NVMM
  • Dr. A.T. Bernards, medical microbiologist, Leiden University Medical Center, NVMM

 

With the help of:

  • Dr. M.A. Pols, senior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • Dr. M.L. Molag, advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • A.L.J. Kortlever- van der Spek, junior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • M.E. Wessels MSc, clinical librarian, Knowledge Institute of the Dutch Association of Medical Specialists

Belangenverklaringen

At the start of the project, the members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These declarations of interest can be requested from the secretariat of the Knowledge Institute of the Dutch Association of Medical Specialists. See below for an overview.

 

Werkgroeplid

Mogelijke conflicterende belangen met betrekking tot deelname werkgroep

Toelichting

Dr. B.W. Schreurs

Presentaties voor Stryker over de Exeter totale heupprothese (educational fee naar afdeling)

Doet reviews voor DEKRA KEMA (betaald)

Voorzitter European Hip Society (onbetaald)

Voorzitter wetenschappelijke adviesraad LROI (onbetaald)

Voorzitter adviesraad botbank Sanquin (onbetaald)

Lid Commissie Orthopedisch Implantaten Classificatie NOV (onbetaald)

 

Dr. P.C. Jutte

Hoofdonderzoeker LEAK-studie (ZonMW)

Voorzitter werkgroep weke delen en bottumoren

Lid werkgroep orthopedische infecties NOV

Lid werkgroep bottumoren NOV

Lid commissie beentumoren Nederland

Lid onderwijscommissie NOV

Lid medische adviesraad patientvereniging Sarcoma NL

 

D.E. Lopuhaä

Geen belangen

 

Dr. R.H.M. ten Broeke

Voorzitter werkgroep "Heup" (Dutch Hip Society) NOV sinds 2015 (onbetaald)

Daarvoor gedurende 3 jaar reeds bestuurslid van deze werkgroep (onbetaald)

Klinisch onderzoek gefinancierd door firma Stryker (RSA en PET-CT-onderzoek bij vergelijking van 2 ongecementeerde cupdesigns) (onbetaald)

 

Dr. W.F.H. Peter

Geen belangen

 

Dr. P.D. Croughs

Geen belangen

 

Dr. S.B.W. Vehmeijer

Directeur Orthoparc (onbetaald)

Bestuurslid Dutch Hip Society (onbetaald)

National Representative European Hip Society (onbetaald)

Consulent Zimmer Biomet (betaald)

 

Dr. B.A. Swierstra

Voorzitter Stichting OrthoResearch (onbetaald)

Advisory Board Arthroplasty Watch (onbetaald)

Lid Wetenschappelijke Advies Raad Landelijke Registratie Orthopaedische Implantaten (onbetaald)

Board of Directors International Society of Orthopaedic Centers (onbetaald)

Coeditor Acta Orthopaedica (onkostenvergoeding)

 

Dr. R.A. Faaij

Geen belangen

 

Dr. A.M.J.S. Vervest

Lid-beroepsgenoot Regionaal Tuchtcollege voor de Gezondheidszorg Den Haag (betaald)

Voorzitter Centrale Opleidings Commissie Tergooi (onbetaald)

 

J. Vooijs

Geen belangen

 

Drs. G. Willemsen – de Mey

Geen belangen

 

Meelezers

Drs. S. Nijssen

ISO 15189 auditor, betaald door RvA

 

Dr. R.J. Rentenaar

Commissie bacteriologie Stichting Kwaliteitsbewaking Medische Laboratoria (SKML) (tegen onkostenvergoeding).

Verschillende producenten stellen soms kleine hoeveelheden van producten ter beschikking kosteloos of tegen gereduceerd tarief t.b.v. verificatie doeleinden

 

Dr. A.T. Bernards

Geen belangen

 

Inbreng patiëntenperspectief

Attention was paid to the patients’ perspective by participation in the working group of the Dutch Arthritis Society and National Association ReumaZorg Nederland. In addition, the Patients Federation Netherlands assessed the draft guideline during the consultation phase and made suggestions for improvement of the guideline.

Methode ontwikkeling

Evidence based

Implementatie

Recommendation

Time needed for implementation:
<1 year,

1 to 3 years or

>3 years

Expected effects on costs

Conditions for implementation

Possible barriers to implementation1

Actions for implementation2

Reponsibility for these actions3

Other remarks

All

<1 year

Reduction

Local motivation and collaboration

See conditions

 

Orthopedic surgeons and hospital management

Not applicable

Werkwijze

The guideline was developed in agreement with the criteria set by the advisory committee on guideline development of the Dutch Association of Medical Specialists (Medisch Specialistische Richtlijnen 2.0; OMS 2011), which are based on the AGREE II instrument (Brouwers (2010); www.agreetrust.org). The guideline was developed using an evidence-based approach endorsing GRADE methodology, and meeting all criteria of AGREE-II. Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a systematic approach for synthesising evidence and grading of recommendations offering transparency at each stage of the guideline development (Guyatt, 2011; Schünemann, 2013).

 

The guideline development process involves a number of phases: a preparatory phase, development phase, commentary phase, and authorisation phase. After authorisation, the guideline has to be disseminated and implemented and its uptake and use have to be evaluated. Finally, the guideline has to be kept up-to-date. Each phase involves a number of practical steps Schünemann, (2014).

 

As a first step in the early preparatory phase, a broad forum discussion was held and all relevant stakeholders were consulted to define and prioritise the key issues the recommendations should address. Subsequently, the methodologist together with the chairman of the working group created a draft list of key issues, which was extensively discussed in the working group.

 

Despite aiming for an update of the guideline from 2010, due to financial constraints not all clinical questions from the former edition could be updated, so it was decided to perform a so-called modular update. Selecting modules with a higher priority for update formed part of this discussion and selection process. This resulted in the following approach.

 

Modules that were updated:

  • Indications for primary total hip arthroplasty.
  • Type of bearing (part of the module surgical techniques).
  • Diameter of the head (part of the module surgical techniques).
  • Surgical approach (part of the module surgical techniques).
  • Systemic antibiotics (part of the module perioperative care in primary total hip arthroplasty).
  • Antibiotic-impregnated bone cement (part of the module perioperative care in primary total hip arthroplasty).
  • Preoperative decolonisation (part of the module perioperative care in primary total hip arthroplasty).
  • Routine follow-up (part of the module postoperative care).

 

Modules considered still valid:

  • cemented versus uncemented hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).

 

Modules removed from the guideline:

  • Resurfacing hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
  • Minimally invasive surgery (part of the module surgical techniques in primary total hip arthroplasty).
  • Guidelines for MRSA carriers (part of the module perioperative care in primary total hip arthroplasty).

 

Modules that were replaced by a reference to related guidelines:

  • Hematogenous infection (part of the module postoperative care).
  • Prevention of thrombo-embolic complications (part of the module perioperative care in primary total hip arthroplasty).
  • Physcial therapy (part of the module perioperative care in primary total hip arthroplasty).

 

Modules not updated because guidelines are expected soon:

  • Anaesthesiological technique (part of the module perioperative care in primary total hip arthroplasty).

 

Modules that were added:

  • Patient Reported Outcome Measures.
  • Place and organisation of fasttrack.
  • Organization of care for frail elderly.

 

The selected (high priority) issues were translated into carefully formulated clinical questions, defining patient/problem, intervention, and prioritising the outcomes relevant for decision-making.

 

The literature was systematically searched using the databases MEDLINE (Ovid), Embase and the Cochrane Database of Systematic Reviews. Selection of the relevant literature was based on predefined inclusion and exclusion criteria and was carried out by a member of the working group in collaboration with the methodologist. For each of the clinical questions, the evidence was summarised by the guideline methodologist using the GRADE approach: a systematic review was performed for each of the relevant outcomes and the quality of evidence was assessed in one of four grades (high, moderate, low, very low) by analysing limitations in study design or execution (risk of bias), inconsistency of results, indirectness of evidence, imprecision, and publication bias. The evidence synthesis was complemented by a working group member considering any additional arguments relevant to the clinical question. Evidence synthesis, complementary arguments, and draft recommendations were extensively discussed in the working group and final recommendations were formulated. Final recommendations are based on the balance of desirable and undesirable outcomes, the quality of the body of evidence across all relevant outcomes, values and preferences, and (if relevant) resource use. The strength of a recommendation reflects the extent to which the guideline panel was confident that desirable effects of the intervention outweigh undesirable effects, or vice versa, across the range of patients for whom the recommendation is intended. The strength of a recommendation is determined by weighting all relevant arguments together, the weight of the body of evidence from the systematic literature analysis, as well as the weight of all complementary arguments. Guideline panels must use judgment in integrating these factors to make a strong or weak recommendation. Thus, a low quality of the body of evidence from the systematic literature analysis does not exclude a strong recommendation, and weak recommendations may follow from high quality evidence Schünemann, (2013).

 

After reaching consensus in the working group, the draft guideline was subjected to peer review by all relevant stakeholders. Amendments were made and agreed upon by the working group, and the final text was presented to the Netherlands Orthopaedic Association (NOV), the Royal Dutch Society for Physical Therapy (KNGF), the Dutch Society of Medical Microbiology (NVMM) and the Dutch Geriatrics Society (NVKG) for formal authorisation and to the National Association ReumaZorg Nederland and the Dutch Arthritis Society for approval. The final guideline was approved by the National Association ReumaZorg Nederland and the Dutch Arthritis Society, and was officially authorised by the Netherlands Orthopaedic Association, the Royal Dutch Society for Physical Therapy, the Dutch Society of Medical Microbiology and the Dutch Geriatrics Society. The guideline was published and is freely accessible in the Dutch guideline database (Richtlijnendatabase, www.richtlijnendatabase.nl). The Dutch guideline database has a modular structure, with each clinical question as a separate entry, thus allowing for modular updates.

 

References

Brouwers M, Kho ME, Browman GP, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. Dec;182:E839-842; doi: 10.1503/cmaj.090449.

Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology. 2011;64 383–394. (doi:10.1016/j.jclinepi.2010. 04.026).

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from https://www.gradepro.org/

Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123-42. doi: 10.1503/cmaj.131237. Epub 2013 Dec 16. PubMed PMID: 24344144.

OMS, Orde van Medisch Specialisten. Eindrapport Medisch Specialistische Richtlijnen 2.0. Available from: https://www.demedischspecialist.nl/onderwerp/raad-kwaliteit. 2011.

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