View Clinical Trial (Medical Research Study)
Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
| City: |
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Boulder |
| State: |
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Colorado |
| Zip Code: |
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80304 |
| Conditions: |
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Osteoarthritis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael
Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10
degrees flexion contracture
- Body mass index less than 35
Exclusion Criteria:
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower
extremity that is not undergoing the TKA
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| NCT ID: |
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NCT00710840 |
| Primary Contact: |
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Principal Investigator
Jennifer E. Stevens, MPT, PhD
University of Colorado, Denver
Jackie Balter, MS
Phone: 303-724-9590
Email: Jackie.Balter@UCHSC.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boulder, Colorado 80304
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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