Prospective, Randomized Clinical Trial Comparing a Novel Motion-Assistive Device to Standard Physical Therapy for Initial Management of Knee Range of Motion after Primary Total Knee Arthroplasty.

This prospective randomized clinical trial assessed a novel device for initial management of knee range of motion (ROM), pain, and function after total knee arthroplasty (TKA). Primary TKA patients with preoperative ROM of at least 5° to 115° were randomized to initial knee motion management: Mizzou BioJoint Flex-novel motion-assistive device with prescribed physical therapy or standard physical therapy-prescribed physical therapy. ROM, pain score, and knee injury and osteoarthritis score for joint replacement (KOOSjr) were obtained preoperatively and 2 weeks, 6 weeks, and 3 months postoperatively. Patient satisfaction for both cohorts and subjective assessments of the MBF device were assessed at 3 months. Readmissions, reoperations, and complications were assessed through 1 year. Nineteen patients were randomized to each cohort, with no significant preoperative differences in demographics, pain score, KOOSjr score, or ROM. Six SPT (31.6%) and 3 MBF (15.8%) patients failed to regain preoperative ROM (

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J.L.C., K.R., C.R.C., and T.M.G. are patent holders in the Mizzou BioJoint Flex device. This small clinical trial device feasibility study met exclusion criteria from having to be registered with ClinicalTrials.gov.