Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Following Surgery?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital for Special Surgery, New York

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Knee immobilizer

    Device

    Participants 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

    Device

    Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Study GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months postoperatively

Secondary outcomes

1

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.

Time frame
2 weeks, 6 weeks, and 1 year postoperatively
2

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.

Time frame
2 weeks, 6 weeks, 3 months and 1 year postoperatively
3

Stiffness - Knee Joint

Incidence of knee stiffness

Time frame
2 weeks, 6 weeks, 3 months, and 1 year postoperatively
4

Wound complications

Incidence of wound complications

Time frame
2 weeks, 6 weeks, 3 months, and 1 year postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Orthopaedic Research and Education Foundation (OREF)

Collaborator