NCT Number: NCT07552415
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10021, United States
Location status: Recruiting
Alexis G Gonzalez, MS
SUB_INVESTIGATOR
Allina Nocon, PhD
CONTACT
David A Kolin, MD
SUB_INVESTIGATOR
Dr. Brian P. Chalmers MD
CONTACT
Gwo-Chin Lee, MD
SUB_INVESTIGATOR
Knee immobilization after revision total knee arthroplasty (TKA) remains unexplored in the literature despite its potential to address key challenges in the post-operative management and rehabilitation in these patients. Revision TKA is typically associated with higher rates of complications such as instability, malalignment, extensor mechanism disruption, and stiffness. Given the intricate nature of revision procedures and the increased risk of suboptimal outcomes, effective strategies for optimizing functional recovery and minimizing post-operative pain are critical. Semirigid extension bracing, a form of knee immobilization, has shown promise in primary TKA in improving pain management, promoting knee range of motion (ROM), and reducing opioid consumption. However, its role in revision TKA remains unknown. Exploring the use of knee immobilization in the revision TKA population could provide a non-pharmacological, cost-effective approach to addressing pain, minimizing complications, and improving long-term functional outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.
Time frame: 3 months postoperatively
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: 2 weeks, 6 months, and 1 year postoperatively
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: 6 weeks, 3 months, 6 months, and 1 year postoperatively
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: 6 weeks, 3 months, 6 months, and 1 year postoperatively
Incidence of knee stiffness
Time frame: 6 weeks, 3 months, 6 months, and 1 year postoperatively
Incidence of wound complications
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Delta compared to preoperative value
Time frame: 90 days postoperatively
Hospital for Special Surgery, New York
Other
Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
