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| Name | Class |
|---|---|
| Orthopaedic Research and Education Foundation (OREF) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | 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. |
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| Control Group | Placebo Comparator | Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks, 6 months, and 1 year postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34507367 | Background | Tarazi JM, Chen Z, Scuderi GR, Mont MA. The Epidemiology of Revision Total Knee Arthroplasty. J Knee Surg. 2021 Nov;34(13):1396-1401. doi: 10.1055/s-0041-1735282. Epub 2021 Sep 10. | |
| 29444666 | Background | Postler A, Lutzner C, Beyer F, Tille E, Lutzner J. Analysis of Total Knee Arthroplasty revision causes. BMC Musculoskelet Disord. 2018 Feb 14;19(1):55. doi: 10.1186/s12891-018-1977-y. |
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| No Knee Immobilizer | Device | Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol. |
|
| 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. | 6 weeks, 3 months, 6 months, and 1 year postoperatively |
| Stiffness - Knee Joint | Incidence of knee stiffness | 6 weeks, 3 months, 6 months, and 1 year postoperatively |
| Wound complications | Incidence of wound complications | 6 weeks, 3 months, 6 months, and 1 year postoperatively |
| Time to achieve physical therapy milestones | 6 weeks, 3 months, 6 months, and 1 year |
| Knee Society Scale Score Delta | Delta compared to preoperative value | 6 weeks, 3 months, 6 months, and 1 year |
| Functional Knee Society Scale Score Delta | Delta compared to preoperative value | 6 weeks, 3 months, 6 months, and 1 year |
| KOOS Jr. Score Delta | Delta compared to preoperative value | 6 weeks, 3 months, 6 months, and 1 year |
| PROMIS-10 Score Delta | Delta compared to preoperative value | 6 weeks, 3 months, 6 months, and 1 year |
| VAS Pain Score Delta | Delta compared to preoperative value | 6 weeks, 3 months, 6 months, and 1 year |
| Total 90 day opioid consumption | 90 days postoperatively |
| 22810157 | Background | Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y. |
| 35587284 | Background | Kaseb MH, Moharrami A, Mirghaderi SP, Fallah E, Razzaghof M, Moazen Jamshidi MM, Poopak A, Mortazavi SMJ. Effect of joint immobilization using extension splint immediately after total knee arthroplasty on post-operative knee function and pain: a randomized clinical trial. Int Orthop. 2022 Aug;46(8):1749-1759. doi: 10.1007/s00264-022-05428-8. Epub 2022 May 19. |