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NCT05678231
Zero Degree Knee Positioner for Improved Earley Knee Extension Following Total Knee Arthroplasty
Conditions: Osteoarthritis, Knee
Sex: All
Ages: 40 Years – 80 Years
Phase: NA
Enrollment: 154
Sponsor: Prisma Health-Midlands
Location: United States
Summary
Studies have demonstrated that early rehabilitation interventions following knee arthroplasty (TKA) can shorten the time needed to regain baseline extension/full extension and gait mechanics.
As telehealth visits and home-based rehabilitation increases with advancements in technology, much of this rehabilitation is projected to be performed at home.
The purpose of this study is to prospectively evaluate early post-operative knee extension and self-reported outcomes in patients using the Zero Degree Knee positioner (ZDK) compared to subjects not using the ZDK.
Patients electing to undergo primary TKA will be recruited into the study and randomized to receive and follow the ZDK protocol post-operatively or standard of care rehabilitation instructions.
Knee extension measurements will be recorded at 2 weeks post-op and patient-reported outcome measurements will be recorded pre-operatively and at various post-op timepoints.
Eligibility Criteria
Inclusion Criteria:Men and women between the ages of 40-80 yearsCandidate for total knee arthroplastyDiagnosis of mild to advanced osteoarthritisThe ability to walk independently at baselineExclusion Criteria:History of knee replacement in operative limb (i.e.
patients undergoing revision surgery)Neuromuscular/skeletal or connective tissue conditions that can alter gait or joint mechanics (joint infection, gout, rheumatoid arthritis)Pregnant womenPrisonersNon-English speakers
Source: ClinicalTrials.gov (NCT05678231). StuddyBuddy aggregates publicly available trial information.