Physical rehabilitation versus no physical rehabilitation after total hip and knee arthroplasties: Protocol for a pragmatic, randomized, controlled, superiority trial (The DRAW1 trial)

Troels Mark-Christensen, Kristian Thorborg, Thomas Kallemose, Thomas Bandholm, Troels Mark-Christensen, Kristian Thorborg, Thomas Kallemose, Thomas Bandholm

Abstract

Background: Following total hip- and knee arthroplasty (THA and TKA), post-discharge physical rehabilitation is common practice, but varies significantly regarding content, duration, intensity and mode of delivery. Recent systematic reviews have found home-based rehabilitation to be as good as outpatient rehabilitation in terms of pain and physical function. We therefore wonder if physical rehabilitation "works" at all when compared to no physical rehabilitation after THA and TKA - "no rehabilitation" defined as no prescribed therapeutic rehabilitation exercises. The purpose of this trial is to compare the effectiveness of home-based telerehabilitation, home-based rehabilitation and no physical rehabilitation following THA and TKA. Methods: This pragmatic, randomized controlled trial will include 168 patients following discharge after THA or TKA, in Bornholm Denmark. Patients will be randomized into one of the three 6-week rehabilitation strategies: home-based telerehabilitation, home-based rehabilitation or no physical rehabilitation. The trial is designed as a superiority trial to test the hypothesis that rehabilitation (home-based telerehabilitation and home-based rehabilitation) is superior to no physical rehabilitation. The primary outcome will be the hip disability and osteoarthritis outcome score (HOOS)/ the knee injury and osteoarthritis outcome score (KOOS)-subscale: function of daily living at first follow-up (end of the 6-weeks' intervention). Additional follow-ups are scheduled at 3 and 12 months. Outcome assessors and data analysts are blinded to group allocation. Conclusions: Knowledge about the effectiveness of the three investigated rehabilitation strategies will help guide the future organization of post-discharge rehabilitation after THA and TKA. Trial registration: Clinicaltrials.gov NCT03750448 (23/11/2018).

Keywords: Rehabilitation; Telerehabilitation.; Total Hip Arthroplasty; Total Joint Replacement; Total Knee Arthroplasty.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2021 Mark-Christensen T et al.

Figures

Figure 1.. Home-based telerehabilitation using ICURA.
Figure 1.. Home-based telerehabilitation using ICURA.
Figure 2.. Home-based rehabilitation using Exorlive.
Figure 2.. Home-based rehabilitation using Exorlive.

References

    1. Allen KD, Golightly YM: State of the evidence. Curr Opin Rheumatol. 2015;27(3):276–283. 10.1097/BOR.0000000000000161
    1. Shan L, Shan B, Suzuki A, et al. : Intermediate and long-term quality of life after total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Am. 2015;97(2):156–168. 10.2106/JBJS.M.00372
    1. Shan L, Shan B, Graham D, et al. : Total hip replacement: a systematic review and meta-analysis on mid-term quality of life. Osteoarthr Cartil. 2014;22(3):389–406. 10.1016/j.joca.2013.12.006
    1. da Silva RR, Santos AAM, de Sampaio Carvalho Júnior J, et al. : Quality of life after total knee arthroplasty: systematic review. Rev Bras Ortop. 2014;49(5):520–527. 10.1016/j.rboe.2014.09.007
    1. Coulter CL, Scarvell JM, Neeman TM, et al. : Physiotherapist-directed rehabilitation exercises in the outpatient or home setting improve strength, gait speed and cadence after elective total hip replacement: a systematic review. J Physiother. 2013;59(4):219–226. 10.1016/S1836-9553(13)70198-X
    1. Artz N, Dixon S, Wylde V, et al. : Physiotherapy provision following discharge after total hip and total knee replacement: a survey of current practice at high-volume NHS hospitals in England and wales. Musculoskeletal Care. 2013;11(1):31–38. 10.1002/msc.1027
    1. Artz N, Elvers KT, Lowe CM, et al. : Effectiveness of physiotherapy exercise following total knee replacement: Systematic review and meta-analysis. BMC Musculoskelet Disord. 2015;16(1):15. 10.1186/s12891-015-0469-6
    1. Westby MD, Kennedy D, Jones D, et al. : Post‐acute physiotherapy for primary total knee arthroplasty (protocol). Cochrane Database Syst Rev. 2008;2. 10.1002/14651858.CD007099
    1. Mark-Christensen T: Kommunal genoptræning efter en total knæalloplastik. Fysioterapeuten webartikel. 2017;07.
    1. Jaglal SB, MacKay C, Corrigan L: Rehabilitation for total joint replacement.Arthritis and Related Conditions in Ontario. ICES Res Atlas. 2004;133–142.
    1. Ponnusamy KE, Naseer Z, El Dafrawy MH, et al. : Post-Discharge Care Duration, Charges, and Outcomes Among Medicare Patients After Primary Total Hip and Knee Arthroplasty. J Bone Joint Surg Am. 2017;99(11): e55. 10.2106/JBJS.16.00166
    1. Artz N, Elvers KT, Lowe CM, et al. : Effectiveness of physiotherapy exercise following total knee replacement: Systematic review and meta-analysis. BMC Musculoskelet Disord. 2015;16(1):15. 10.1186/s12891-015-0469-6
    1. Li D, Yang Z, Kang P, et al. : Home-Based Compared with Hospital-Based Rehabilitation Program for Patients Undergoing Total Knee Arthroplasty for Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2017;96(6):440–447. 10.1097/PHM.0000000000000621
    1. Florez-Garcia M, Garcia-Perez F, Curbelo R, et al. : Efficacy and safety of home-based exercises versus individualized supervised outpatient physical therapy programs after total knee arthroplasty: a systematic review and meta-analysis. Knee Surgery Sport Traumatol Arthrosc. 2017;25(11):3340–3353. 10.1007/s00167-016-4231-x
    1. Lowe CJM, Davies L, Sackley CM, et al. : Effectiveness of land-based physiotherapy exercise following hospital discharge following hip arthroplasty for osteoarthritis: an updated systematic review. Physiotherapy. 2015;101(3):252–265. 10.1016/j.physio.2014.12.003
    1. Secretariat Medical Advisory: Physiotherapy rehabilitation after total knee or hip replacement: an evidence-based analysis (Structured abstract). Heal Technol Assess Database. 2005;5(4):90.
    1. Hamilton DF, Beard DJ, Barker KL, et al. : Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial. BMJ. 2020;371: m3576. 10.1136/bmj.m3576
    1. Mark-Christensen T, Juhl C, Thorborg K, et al. : Is physical rehabilitation superior to no physical rehabilitation following total knee arthroplasty? A systematic review and meta-analysis. medRxiv. 2020. 10.1101/2020.04.29.20084392
    1. Evgeniadis G, Beneka A, Malliou P, et al. : Effects of pre- or postoperative therapeutic exercise on the quality of life, before and after total knee arthroplasty for osteoarthritis. J Back Musculoskelet Rehabil. 2008;21(3):161–169. 10.3233/BMR-2008-21303
    1. Monticone M, Ferrante S, Rocca B, et al. : Home-based functional exercises aimed at managing kinesiophobia contribute to improving disability and quality of life of patients undergoing total knee arthroplasty: A randomized controlled trial. Arch Phys Med Rehabil. 2013;94(2):231–239. 10.1016/j.apmr.2012.10.003
    1. Bandholm T, Christensen R, Thorborg K, et al. : Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017;51(20):1494–1501. 10.1136/bjsports-2017-097527
    1. Chan AW, Tetzlaff JM, Altman DG, et al. : SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. 10.7326/0003-4819-158-3-201302050-00583
    1. Mark-Christensen T: DRAW1. Harvard Dataverse, V1. 2021. 10.7910/DVN/BUNJQV
    1. Boutron I, Altman DG, Moher D, et al. : CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40–47. 10.7326/M17-0046
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. : [Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide]. Gesundheitswesen. 2016;78(3):175–88. 10.1055/s-0041-111066
    1. Slade SC, Dionne CE, Underwood M, et al. : Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016;50(23):1428–1437. 10.1136/bjsports-2016-096651
    1. U.S. National Library of .
    1. National Videnskabsetisk Komite: Ethics Committee of the Capital Region of Denmark.
    1. Datatilsynet: Danish Data Protection Agency.
    1. Juhl CB, Roth S, Schierbeck R, et al. : Effectiveness of technology assisted exercise compared to usual care in total knee arthroplasty. Osteoarthr Cartil. 2016;24(1):S473. 10.1016/j.joca.2016.01.864
    1. Juhl CB, Roth S, Schierbeck R, et al. : Effectiveness of technology assisted exercise compared to usual care in total hip arthroplasty. Osteoarthr Cartil. 2016;24(1):S477. 10.1016/j.joca.2016.01.871
    1. Badenoch D, Heneghan C, Nunan D, et al. : Catalogue Of Bias.University of Oxford.
    1. Pedersen BK, Andersen LB: Fysisk Aktivitet - Håndbog Om Forebyggelse Og Behandling.København S;2011.
    1. Rask B: Evaluering Af Genoptræningsforløb Med ICURA Trainer Tilbudt Borgere Med Ny Hofte Eller Nyt Knæ.2015.
    1. Nilsdotter AK, Lohmander LS, Klässbo M, et al. : Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003;4:10. 10.1186/1471-2474-4-10
    1. Roos EM, Lohmander LS: The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1(64):64. 10.1186/1477-7525-1-64
    1. Fitzgerald GK, Hinman RS, Zeni J, Jr, et al. : OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis. Osteoarthr Cartil. 2015;23(5):803–814. 10.1016/j.joca.2015.03.013
    1. Dobson F, Hinman RS, Roos EM, et al. : OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthr Cartil. 2013;21(8):1042–1052. 10.1016/j.joca.2013.05.002
    1. Mahomed N, Gandhi R, Daltroy L, et al. : The Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty. Arthritis. 2011;2011:591253. 10.1155/2011/591253
    1. Roos EM, Toksvig-Larsen S: Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17. 10.1186/1477-7525-1-17
    1. Peer MA, Lane J: The Knee Injury and Osteoarthritis Outcome Score (KOOS): a review of its psychometric properties in people undergoing total knee arthroplasty. J Orthop Sports Phys Ther. 2013;43(1):20–28. 10.2519/jospt.2013.4057
    1. Thorborg K, Roos EM, Bartels EM, et al. : Validity, reliability and responsiveness of patient-reported outcome questionnaires when assessing hip and groin disability: a systematic review. Br J Sports Med. 2010;44(16):1186–1196. 10.1136/bjsm.2009.060889
    1. Unver B, Kahraman T, Kalkan S, et al. : Test-retest reliability of the 50-foot timed walk and 30-second chair stand test in patients with total hip arthroplasty. Acta Orthop Belg. 2015;81(3):435–441.
    1. Unver B, Kalkan S, Yuksel E, et al. : Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015;23(4):184–187. 10.1590/1413-78522015230401018
    1. Nilsdotter A, Bremander A: Measures of hip function and symptoms: Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), Lequesne Index of Severity for Osteoarthritis of the Hip (LISOH), and American Academy of Orthopedic Surgeons (AAOS) Hip and Knee Questionnaire. Arthritis Care Res (Hoboken). 2011;63 Suppl 11:S200–7. 10.1002/acr.20549
    1. Zelle BA, Bhandari M, Sanchez AI, et al. : Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013;27(3):177–181. 10.1097/BOT.0b013e31825cf367
    1. Dansk Hoftelloplastikregister årsrapport 2019: Danish Hip Arthroplasty Register.2019.
    1. Dansk Knæalloplastikregister årsrapport 2019: Danish Knee Arthroplasty Register.2019.
    1. Culliford D, Maskell J, Judge A, et al. : Future projections of total hip and knee arthroplasty in the UK: results from the UK Clinical Practice Research Datalink. Osteoarthr Cartil. 2015;23(4):594–600. 10.1016/j.joca.2014.12.022
    1. Kurtz S, Ong K, Lau E, et al. : Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780–785. 10.2106/JBJS.F.00222
    1. Hulley SB: Clinical Research.4th ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins;2013.
    1. Ioannidis JPA: Why Most Clinical Research Is Not Useful. PLoS Med. 2016;13(6):e1002049. 10.1371/journal.pmed.1002049
    1. : Early patient-reported outcomes versus objective function after total hip and knee arthroplasty: a prospective cohort study. Bone Joint J.2017;99-B(9) : 10.1302/0301-620X.99B9.BJJ-2016-1343.R11167-117510.1302/0301-620X.99B9.BJJ-2016-1343.R1

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