About this trial
The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.
Participants will be assigned to one of two groups.
One group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.
Patients undergoing revision TKA of one or both components.
Disqualifiers
Patients who are undergoing revision TKA for stiffness.
Patients with occult infection not recognized prior to revision.
Patients with hinged TKA component reconstructions.
Patients undergoing revision for liner exchange.
Trial design
Parallel
Treatments tested in this trial
Knee immobilizer
DeviceParticipants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.
No Knee Immobilizer
DeviceParticipants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.
Treatment groups
Trial outcomes
Primary outcomes
Range of motion (degrees) - knee joint; measured using digital goniometer
Active and Passive knee flexion and extension range of motion will be measured in degrees using a standardized digital goniometer at each timepoint.
Secondary outcomes
Range of motion (degrees) - knee joint; measured using a digital goniometer
Active and passive knee flexion and extension will be measured in degrees using a standardized digital goniometer. Measurements will be obtained with the patient seated for flexion and supine for extension at each timepoint.
Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape
Knee swelling will be measured as mid-patellar circumference (cm) with knee in full extension using a standardized flexible measuring tape at each postoperative timepoint.
Stiffness - Knee Joint
Incidence of knee stiffness
Wound complications
Incidence of wound complications
Sponsors and contacts
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Hospital for Special Surgery, New York
Lead sponsor
Orthopaedic Research and Education Foundation (OREF)
Collaborator