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

• ClinicalTrials.gov Identifier: NCT00710840
• Recruitment Status: Completed
• First Posted: July 4, 2008
• Results First Posted: May 15, 2015
• Last Update Posted: June 10, 2015
• Sponsor: University of Colorado, Denver
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Procedure: Minimally Invasive Total Knee Arthroplasty [TKA Min]; Procedure: Total Knee Arthroplasty (TKA) Traditional	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
• Study Start Date: June 2008
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
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 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.; Other Name: TKA Min
Active Comparator: 2	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.; Other Name: TKA Traditional

Outcome Measures

Primary Outcome Measures :

1. Quadriceps Muscle Force [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ]
2. Knee Range of Motion [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ]
   Knee Flexion Active Range of Motion (AROM)

Secondary Outcome Measures :

1. Functional Performance: 6 Minute Walk (6MW) Distance [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ]
2. Functional Performance: Stair Climb Test [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado Health Sciences Center

Boulder, Colorado, United States, 80304

National Jewish Medical and Research Center

Denver, Colorado, United States, 80206

University of Colorado Health Sciences Center

Denver, Colorado, United States, 80262

Sponsors and Collaborators

University of Colorado, Denver

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

Investigators

• 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: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00710840
• Other Study ID Numbers: 06-0183; R03AR054538 ( U.S. NIH Grant/Contract ); 1R03AR054538-01A2 ( U.S. NIH Grant/Contract )
• First Posted: July 4, 2008
• Results First Posted: May 15, 2015
• Last Update Posted: June 10, 2015
• Last Verified: March 2015

Keywords provided by University of Colorado, Denver:

Knee Replacement; Knee OA; OA

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases