Clinical trial NCT00710840: Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Official title: Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Knee Replacement
Knee OA
OA
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-07-04
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 criteria: 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 ≤ 40 kg/m2

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

Primary outcomes:
measure: Quadriceps Muscle Force
timeFrame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
measure: Knee Range of Motion
timeFrame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Secondary outcomes:
measure: Functional Performance: 6 Minute Walk (6MW) Distance
timeFrame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
measure: Functional Performance: Stair Climb Test
timeFrame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer E. Stevens, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Michael Dayton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado School of Medicine
name: Wendy Kohrt, PhD
role: PRINCIPAL_INVESTIGATOR
References: