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

NCT ID: NCT00710840

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-01-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Minimally Invasive Total Knee Arthroplasty [TKA Min]

Intervention Type: PROCEDURE

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 Traditional, 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.

2

Group Type: ACTIVE_COMPARATOR

Total Knee Arthroplasty (TKA) Traditional

Intervention Type: PROCEDURE

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.

Interventions

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 Traditional, 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.

Intervention Type: PROCEDURE

Total Knee Arthroplasty (TKA) Traditional

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.

Intervention Type: PROCEDURE

Other Intervention Names

TKA Min; TKA Traditional

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer E. Stevens, MPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Michael Dayton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Wendy Kohrt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

University of Colorado Health Sciences Center

Boulder, Colorado, United States

National Jewish Medical and Research Center

Denver, Colorado, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

R03AR054538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R03AR054538-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-0183

Identifier Type: -

Identifier Source: org_study_id