Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial

Authors: Matthew G. Liptak, Annika Theodoulou, Billingsley Kaambwa, Steve Saunders, Scott W. Hinrichs, Richard J. Woodman, Jeganath Krishnan

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Physical rehabilitation is required to enhance functional outcomes and overall recovery following total knee arthroplasty (TKA). However, there are no universally accepted clinical guidelines available to consistently structure rehabilitation for TKA patients. A common method is rehabilitation provided in an outpatient setting, on a one-to-one treatment basis. This method is resource-intensive and outcomes must be compared to less costly alternatives such as home-based rehabilitation. The current study will analyse a novel home-based rehabilitation program. The Maxm skate is a portable, lower-limb, postoperative, rehabilitation exercise device for individual use in a hospital or home-based setting. This study was developed to compare the safety, efficacy and cost-effectiveness of the Maxm Skate rehabilitation program to standard rehabilitative care following TKA. The primary outcome is the range of motion (ROM) achieved by patients who received the Maxm Skate program compared to standard care at three months post TKA. Secondary outcomes include patient-reported outcomes, costs and functional evaluations which will be collected at multiple time-points up to 12 months after TKA.

Methods

This is a single-blinded, randomised controlled trial (RCT) in which 116 eligible participants consented for primary TKA will be randomly allocated to receive either the Maxm Skate rehabilitation program or standard rehabilitative care. Fifty-eight participants per group will provide 90% power (α = 0.05) to detect 10° of difference in ROM between groups at three months after TKA, assuming a within-group standard deviation of 16° and allowing for 5% loss to follow-up. Participants randomised to the Maxm Skate group will use the skate device and accompanying iOS App and sensors to complete rehabilitation exercises, as outlined in the Maxm Skate Rehabilitation Guide. Outcomes will be compared to those receiving standard rehabilitative care.
A blinded physiotherapist will evaluate functional outcomes preoperatively and at 2, 4, 6, 12, 26 and 52 weeks after TKA. The functional assessment will include measures of knee ROM, pain, isometric knee strength, balance and knee/thigh circumference. Limited measures will also be assessed at day 2 postoperatively by an alternate, unblinded physiotherapist. Clinical outcome measures will be administered preoperatively and at 6, 12 and 52 weeks postoperatively. An economic evaluation will be conducted and participants will be screened for adverse event occurrences from the time of consent to 12 months postoperatively.

Discussion

This RCT will be the first to investigate the safety, efficacy and cost-effectiveness of the home-based Maxm Skate Rehabilitation program, in comparison to standard rehabilitative care following primary TKA.

Trial registration

Australian New Zealand Clinical Trials Registry, ACTRN12616001081​404p. Registered on 11 August 2016.
Appendix
Available only for authorised users
Literature
1.
Oatis CA, Li W, JM DR, Hoover MJ, Johnston KK, Butz MK, et al. Variations in delivery and exercise content of physical therapy rehabilitation following total knee replacement surgery: a cross-sectional observation study. Int J Phys Med Rehabil. 2014;Suppl 5:002.PubMedPubMedCentral
2.
Pozzi F, Snyder-Mackler L, Zeni J. Physical exercise after knee arthroplasty: a systematic review of controlled trials. Eur J Phys Rehabil Med. 2013;49(6):877–92.PubMedPubMedCentral
3.
Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010;468(1):57–63.CrossRef
4.
Rutherford RW, Jennings JM, Levy DL, Parisi TJ, Martin JR, Dennis DA. Revision Total knee arthroplasty for arthrofibrosis. J Arthroplast. 2018;33(7S):S177–81.CrossRef
5.
Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, et al. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplast. 2013;28(8 Suppl):116–9.CrossRef
6.
Cheuy VA, JRH F, Paxton RJ, Bade MJ, Zeni JA, Stevens-Lapsley JE. Arthrofibrosis associated with total knee arthroplasty. J Arthroplast. 2017;32(8):2604–11.CrossRef
7.
Hefzy MS, Kelly BP, Cooke TD. Kinematics of the knee joint in deep flexion: a radiographic assessment. Med Eng Phys. 1998;20(4):302–7.CrossRef
8.
Mulholland SJ, Wyss UP. Activities of daily living in non-Western cultures: range of motion requirements for hip and knee joint implants. Int J Rehabil Res. 2001;24(3):191–8.CrossRef
9.
Rowe PJ, Myles CM, Walker C, Nutton R. Knee joint kinematics in gait and other functional activities measured using flexible electrogoniometry: how much knee motion is sufficient for normal daily life? Gait Posture. 2000;12(2):143–55.CrossRef
10.
Bellemans J, Banks S, Victor J, Vandenneucker H, Moemans A. Fluoroscopic analysis of the kinematics of deep flexion in total knee arthroplasty. Influence of posterior condylar offset. J Bone Joint Surg (Br). 2002;84(1):50–3.CrossRef
11.
Fu H, Wang J, Zhang W, Cheng T, Zhang X. No clinical benefit of high-flex total knee arthroplasty. A meta-analysis of randomized controlled trials. J Arthroplast. 2015;30(4):573–9.CrossRef
12.
Naylor J, Harmer A, Fransen M, Crosbie J, Innes L. Status of physiotherapy rehabilitation after total knee replacement in Australia. Physiother Res Int. 2006;11(1):35–47.CrossRef
13.
Mistry JB, Elmallah RD, Bhave A, Chughtai M, Cherian JJ, McGinn T, et al. Rehabilitative guidelines after total knee arthroplasty: a review. J Knee Surg. 2016;29(3):201–17.CrossRef
14.
Peter WF, Nelissen RG, Vlieland TP. Guideline recommendations for post-acute postoperative physiotherapy in total hip and knee arthroplasty: are they used in daily clinical practice? Musculoskeletal Care. 2014;12(3):125–31.CrossRef
15.
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, Knee & Shoulder Arthroplasty: 2017 Annual Report. Adelaide: AOA; 2017.
16.
Mockford BJ, Thompson NW, Humphreys P, Beverland DE. Does a standard outpatient physiotherapy regime improve the range of knee motion after primary total knee arthroplasty? J Arthroplasty. 2008;23(8):1110–4.
17.
Rajan RA, Pack Y, Jackson H, Gillies C, Asirvatham R. No need for outpatient physiotherapy following total knee arthroplasty: a randomized trial of 120 patients. Acta Orthop Scand. 2004;75(1):71–3.CrossRef
18.
Ko V, Naylor J, Harris I, Crosbie J, Yeo A, Mittal R. One-to-one therapy is not superior to group or home-based therapy after total knee arthroplasty: a randomized, superiority trial. J Bone Joint Surg Am. 2013;95(21):1942–9.CrossRef
19.
Florez-Garcia M, Garcia-Perez F, Curbelo R, Perez-Porta I, Nishishinya B, Rosario Lozano MP, 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 Surg Sports Traumatol Arthrosc. 2017;25(11):3340–53.CrossRef
20.
Kramer JF, Speechley M, Bourne R, Rorabeck C, Vaz M. Comparison of clinic- and home-based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res. 2003;410:225–34.
21.
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, Knee and Shoulder Arthroplasty. Annual Report, 2018. Adelaide: AOA; 2018.
22.
Pua YH, Seah FJ, Seet FJ, Tan JW, Liaw JS, Chong HC. Sex differences and impact of body mass index on the time course of knee range of motion, knee strength, and gait speed after total knee arthroplasty. Arthritis Care Res. 2015;67(10):1397–405.CrossRef
23.
Gustavson AM, Wolfe P, Falvey JR, Eckhoff DG, Toth MJ, Stevens-Lapsley JE. Men and women demonstrate differences in early functional recovery after total knee arthroplasty. Arch Phys Med Rehabil. 2016;97(7):1154–62.CrossRef
24.
Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998;80(1):63–9.CrossRef
25.
Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96.CrossRef
26.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43.CrossRef
27.
Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005;64(1):34–7.CrossRef
28.
Zhou Z, Yew KS, Arul E, Chin PL, Tay KJ, Lo NN, et al. Recovery in knee range of motion reaches a plateau by 12 months after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015;23(6):1729–33.CrossRef
29.
Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010;91(11):1770–6.CrossRef
30.
Lauermann SP, Lienhard K, Item-Glatthorn JF, Casartelli NC, Maffiuletti NA. Assessment of quadriceps muscle weakness in patients after total knee arthroplasty and total hip arthroplasty: methodological issues. J Electromyogr Kinesiol. 2014;24(2):285–91.CrossRef
31.
Schache MB, JA MC, Webster KE. Lower limb strength following total knee arthroplasty: a systematic review. Knee. 2014;21(1):12–20.CrossRef
32.
Harikesavan K, Chakravarty RD, Maiya AG. Influence of early mobilization program on pain, self-reported and performance based functional measures following total knee replacement. J Clin Orthop Trauma. 2018. In press.
33.
Hall M, Hinman RS, Wrigley TV, Kasza J, Lim BW, Bennell KL. Knee extensor strength gains mediate symptom improvement in knee osteoarthritis: secondary analysis of a randomised controlled trial. Osteoarthr Cartil. 2018;26(4):495–500.CrossRef
34.
Skou ST, Wise BL, Lewis CE, Felson D, Nevitt M, Segal NA, et al. Muscle strength, physical performance and physical activity as predictors of future knee replacement: a prospective cohort study. Osteoarthr Cartil. 2016;24(8):1350–6.CrossRef
35.
Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, et al. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthr Cartil. 2013;21(8):1042–52.CrossRef
36.
Devlin N, et al. Valuing Health-Related Quality of Life: An EQ-5D-5L Value Set for England. London: Office of Health Economics; 2016.
37.
Glick HA, Briggs AH, Polsky D. Quantifying stochastic uncertainty and presenting results of cost-effectiveness analyses. Expert Rev Pharmacoecon Outcomes Res. 2001;1(1):25–36.CrossRef
38.
Briggs AH, O’Brien BJ, Blackhouse G. Thinking outside the box: recent advances in the analysis and presentation of uncertainty in cost-effectiveness studies. Annu Rev Public Health. 2002;23:377–401.CrossRef
39.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.CrossRef
40.
Schiavone Panni A, Cerciello S, Vasso M, Tartarone M. Stiffness in total knee arthroplasty. J Orthop Traumatol. 2009;10(3):111–8.CrossRef
41.
Royal Australasian College of Surgeons. Rehabilitation Pathways Following Hip and Knee Arthroplasty. North Adelaide: Royal Australasian College of Surgeons; 2018.
42.
Schilling C, Keating C, Barker A, Wilson SF, Petrie D. Predictors of inpatient rehabilitation after total knee replacement: an analysis of private hospital claims data. Med J Aust. 2018;209(5):222–7.CrossRef
Metadata
Title
The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial
Authors
Matthew G. Liptak
Annika Theodoulou
Billingsley Kaambwa
Steve Saunders
Scott W. Hinrichs
Richard J. Woodman
Jeganath Krishnan
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3102-9

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial

Study protocol

The effect of manual therapy and exercise on age-related lung function: study protocol for a randomised controlled trial

Study protocol

Virtual training leads to real acute physical, cognitive, and neural benefits on healthy adults: study protocol for a randomized controlled trial

Study protocol

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial

Research

Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis

Methodology

Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial