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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00710840
First received: June 27, 2008
Last updated: May 14, 2015
Last verified: March 2015
  Purpose
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 Intervention Phase
Osteoarthritis
Procedure: Minimally Invasive Total Knee Arthroplasty [TKA Min]
Procedure: Total Knee Arthroplasty (TKA) Traditional
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Quadriceps Muscle Force [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Knee Range of Motion [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Knee Flexion Active Range of Motion (AROM)


Secondary Outcome Measures:
  • Functional Performance: 6 Minute Walk (6MW) Distance [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Functional Performance: Stair Climb Test [ Time Frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    This outcome measures the time (seconds) it takes to climb up and back down 12 steps.


Enrollment: 44
Study Start Date: June 2008
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710840

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     History of Changes
Other Study ID Numbers: 06-0183  R03AR054538  1R03AR054538-01A2 
Study First Received: June 27, 2008
Results First Received: March 18, 2015
Last Updated: May 14, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
Knee Replacement
Knee OA
OA

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 30, 2016