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Completed

NCT Number: NCT00710840

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Health Sciences Center, Boulder, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally Invasive Total Knee Arthroplasty [TKA Min]

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.

Other names: TKA Min

Total Knee Arthroplasty (TKA) Traditional

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.

Other names: TKA Traditional

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jul 4, 2008
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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