Dataset Information

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.

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 (??=?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, ACTRN12616001081404p . Registered on 11 August 2016.

SUBMITTER: Liptak MG

PROVIDER: S-EPMC6329189 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

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.

Liptak Matthew G MG Theodoulou Annika A Kaambwa Billingsley B Saunders Steve S Hinrichs Scott W SW Woodman Richard J RJ Krishnan Jeganath J

Trials 20190110 1

<h4>Background</h4>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 rehabil ...[more]

PMID: 30630494

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Project description:Background: Continuous passive motion (CPM) is frequently used during rehabilitation following total knee arthroplasty (TKA). Low-load resistance training (LLRT) using continuous active motion (CAM) devices is a promising alternative. We investigated the effectiveness of CPM compared to LLRT using the affected leg (CAMuni) and both legs (CAMbi) in the early post-operative rehabilitation.Hypotheses(I) LLRT (CAMuni and CAMbi) is superior to CPM, (II) additional training of the unaffected leg (CAMbi) is more effective than unilateral training (CAMuni). Materials and Methods: Eighty-five TKA patients were randomly assigned to three groups, respectively: (i) unilateral CPM of the operated leg; (ii) unilateral CAM of the operated leg (CAMuni); (iii) bilateral alternating CAM (CAMbi). Patients were assessed 1 day before TKA (pre-test), 1 day before discharge (post-test), and 3 months post-operatively (follow-up).Primary outcomeactive knee flexion range of motion (ROMFlex).Secondary outcomesactive knee extension ROM (ROMExt), swelling, pain, C-reactive protein, quality of life (Qol), physical activity, timed-up-and-go performance, stair-climbing performance, quadriceps muscle strength. Analyses of covariances were performed (modified intention-to-treat and per-protocol). Results: Hypothesis I: Primary outcome: CAMbi resulted in a higher ROMFlex of 9.0° (95%CI -18.03-0.04°, d = 0.76) and 6.3° (95%CI -14.31-0.99°, d = 0.61) compared to CPM at post-test and follow-up, respectively.Secondary outcomesAt post-test, C-reactive protein was lower in both CAM groups compared with CPM. Knee pain was lower in CAMuni compared to CPM. Improved ROMExt, reduced swelling, better stair-climbing and timed-up-and-go performance were observed for CAMbi compared to CPM. At follow-up, both CAM groups reported higher Qol and CAMbi showed a better timed-up-and-go performance. Hypothesis II: Primary outcome: CAMbi resulted in a higher knee ROMFlex of 6.5° (95%CI -2.16-15.21°, d = 0.56) compared to CAMuni at post-test.Secondary outcomesAt post-test, improved ROMExt, reduced swelling, and better timed-up-and-go performance were observed in CAMbi compared to CAMuni. Conclusions: Additional LLRT of the unaffected leg (CAMbi) seems to be more effective for recovery of function than training of the affected leg only (CAMuni), which may be mediated by positive transfer effects from the unaffected to the affected limb (cross education) and/or preserved neuromuscular function of the trained, unaffected leg. Trial Registration: ClinicalTrials.gov Identifier: NCT02062138.

Project description:Purpose Total knee arthroplasty (TKA) is widely recognized as an effective treatment for end-stage knee osteoarthritis (OA). Compared with conventional TKA, robotic-arm assisted TKA may improve patients’ functionality and resulting quality of life by more accurate and precise component placement. Currently, the literature on cost-effectiveness of robotic-arm assisted TKA in the US is limited. The objective of this study was to assess the cost-effectiveness of robotic-arm assisted TKA relative to TKA in the Medicare-aged population including exploring the impact of hospital volume on cost-effectiveness outcomes. Methods We developed a decision-analytic model to evaluate the costs, health outcomes, and incremental cost-effectiveness ratio (ICER) of robotic-arm assisted TKA vs TKA in Medicare population with OA. We evaluated cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY). We sourced costs from the literature including episode-of-care (EOC) costs from a Medicare study. We assessed cost-effectiveness of robotic-arm assisted TKA by hospital procedure volume and conducted deterministic (DSA) and probabilistic sensitivity analysis (PSA). Results For the average patient treated in a hospital with an annual volume of 50 procedures, robotic-arm assisted TKA resulted in a total QALY of 6.18 relative to 6.17 under conventional TKA. Total discounted costs per patient were $32,535 and $31,917 for robotic-arm assisted TKA and conventional TKA, respectively. Robotic-arm assisted TKA was cost-effective in the base case with an ICER of $41,331/QALY. In univariate DSA, cost-effectiveness outcomes were most sensitive to the annual hospital procedure volume. Robotic-arm assisted TKA was cost-effective at a WTP of $50,000/QALY only when hospital volume exceeded 49 procedures per year. In PSA, robotic-arm assisted TKA was cost-effective at a $50,000/QALY WTP threshold in 50.4% of 10,000 simulations. Conclusions Despite high robotic purchase costs, robotic-arm assisted TKA is likely to be cost-effective relative to TKA in the Medicare population with knee OA in high-volume hospitals through lowering revision rates and decreasing post-acute care costs. Higher-volume hospitals may deliver higher value in performing in robotic-arm assisted TKA.

Dataset Information

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.

Background

Methods

Discussion

Trial registration

Publications

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.

Similar Datasets

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