Aseptic Revision Knee Arthroplasty, Stiffness Following Revision Knee Arthroplasty
Conditions
Keywords
revision arthroplasty, stiffness, knee swelling
Brief summary
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.
Detailed description
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.
Interventions
DEVICEKnee immobilizer
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.
DEVICENo Knee Immobilizer
Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.
Sponsors
Hospital for Special Surgery, New York
Orthopaedic Research and Education Foundation (OREF)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * History of VTE/PE. * Patients on pre-operative anticoagulation. * BMI ≥ 40. * Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)/day within 90 days of revision TKA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion (degrees) - knee joint; measured using digital goniometer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion (degrees) - knee joint; measured using a digital goniometer | 2 weeks, 6 weeks, 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. |
| Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape | 2 weeks, 6 weeks, 3 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. |
| Stiffness - Knee Joint | 2 weeks, 6 weeks, 3 months, and 1 year postoperatively | Incidence of knee stiffness |
| Wound complications | 2 weeks, 6 weeks, 3 months, and 1 year postoperatively | Incidence of wound complications |
| Time to achieve physical therapy milestones | 2 weeks, 6 weeks, 3 months, and 1 year | — |
| Knee Society Scale Score Delta | 2 weeks, 6 weeks, 3 months, and 1 year | Delta compared to preoperative value |
| Functional Knee Society Scale Score Delta | 2 weeks, 6 weeks, 3 months, and 1 year | Delta compared to preoperative value |
| KOOS Jr. Score Delta | 2 weeks, 6 weeks, 3 months, and 1 year | Delta compared to preoperative value |
| PROMIS-10 Score Delta | 2 weeks, 6 weeks, 3 months, and 1 year | Delta compared to preoperative value |
| VAS Pain Score Delta | 2 weeks, 6 weeks, 3 months, and 1 year | Delta compared to preoperative value |
| Total 90 day opioid consumption | 90 days postoperatively | — |
Countries
United States
Outcome results
None listed