Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Total Knee Arthroplasty (TKA) Traditional; Procedure: Minimally Invasive Total Knee Arthroplasty [TKA Min]

• Registration Number: NCT00710840
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-04
• Primary Completion: 2011-02
• Study Completion: 2012-01
• Status Verified: 2015-03
• Results First Submitted: 2015-03-18
• Results First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-05-14
• Results First Posted: 2015-05-15
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Total Knee Arthroplasty (TKA) Traditional	-
1	Minimally Invasive Total Knee Arthroplasty [TKA Min]	-

Primary Outcome Measures

Name	Time	Method
Knee Range of Motion	Measured pre-operatively; post-surgery at 4 weeks and 12 weeks	Knee Flexion Active Range of Motion (AROM)
Quadriceps Muscle Force	Measured pre-operatively; post-surgery at 4 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Functional Performance: 6 Minute Walk (6MW) Distance	Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Functional Performance: Stair Climb Test	Measured pre-operatively; post-surgery at 4 weeks and 12 weeks	This outcome measures the time (seconds) it takes to climb up and back down 12 steps.

Trial Locations

Locations (2)

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States