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

摘要

BackgroundPhysical 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.