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| Sponsor: | Greg Olender |
|---|---|
| Collaborator: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Information provided by (Responsible Party): | Greg Olender, University of Colorado at Denver and Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00710840 |
Purpose
Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Procedure: Minimally Invasive Total Knee Arthroplasty [TKA(min)] Procedure: Total Knee Arthroplasty (TKA) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty |
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Minimally Invasive Total Knee Arthroplasty [TKA(min)]
TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
Other Name: TKA(min)
|
| Active Comparator: 2 |
Procedure: Total Knee Arthroplasty (TKA)
TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
Other Name: TKA
|
More than 400,000 TKAs are performed each year in the United States to alleviate pain and disability associated with knee OA. Although this procedure reliably reduces pain and improves function in people with knee OA, recovery of the strength of the quadriceps muscle to normal levels is rare. For years after a TKA, performance while walking or while doing a more physically demanding activity, such as stair climbing, is also significantly lower in people who have had a TKA than in healthy adults of the same age. Within the past few years, less invasive TKA surgical techniques have been developed as promising alternatives to traditional TKA. Minimally invasive TKA, or TKA(min), achieves the same surgical objectives, but possibly without doing as much damage to the quadriceps muscle as is seen with traditional TKA. No studies, however, have specifically investigated how TKA(min) might preserve quadriceps muscle function. This study will determine whether TKA(min) is better than TKA at improving quadriceps muscle force production and activation, increasing knee range of motion, and reducing post-operative pain to improve overall functional outcomes.
Participants who are scheduled to undergo knee replacement surgery will be randomly assigned to receive either traditional TKA or TKA(min). Prior to surgery, participants will attend a 30-minute orientation session and undergo certain tests to evaluate knee function. Functional testing will include timed walking, stair climbing, balance testing, and knee flexibility measurements. Other evaluations will include thigh muscle strength and activation testing, which uses brief electrical pulses to determine if the muscles are contracted as much as possible, and health status questionnaires. After the operation, participants will be instructed to use walking aids, such as a walker, crutches, or a cane, for a period of time. Participants will attend study visits for repeat testing 48 hours following surgery; at Months 1, 3, and 6; and at Years 1 and 2.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Boulder, Colorado, United States, 80304 | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80206 | |
| Principal Investigator: | Jennifer E. Stevens, MPT, PhD | University of Colorado, Denver |
| Principal Investigator: | Michael Dayton, MD | University of Colorado, Denver |
| Principal Investigator: | Wendy Kohrt, PhD | University of Colorado School of Medicine |
More Information
| Responsible Party: | Greg Olender, Jennifer Stevens-Lapsley, University of Colorado at Denver and Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00710840 History of Changes |
| Other Study ID Numbers: | R03 AR054538, R03AR054538, 1R03AR054538-01A2 |
| Study First Received: | June 27, 2008 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Federal Government |
|
Knee Replacement Knee OA OA |
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |