Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Minimally Invasive Total Knee Arthroplasty [TKA Min]; Total Knee Arthroplasty (TKA) Traditional
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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 intervention name(s): TKA Min; TKA Traditional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Replacement; Knee OA; OA