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

14 maj 2015 uppdaterad av: University of Colorado, Denver

Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

44

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Colorado
      • Boulder, Colorado, Förenta staterna, 80304
        • University of Colorado Health Sciences Center
      • Denver, Colorado, Förenta staterna, 80262
        • University of Colorado Health Sciences Center
      • Denver, Colorado, Förenta staterna, 80206
        • National Jewish Medical and Research Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
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.
Andra namn:
  • TKA Min
Aktiv komparator: 2
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.
Andra namn:
  • TKA Traditional

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quadriceps Muscle Force
Tidsram: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Range of Motion
Tidsram: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Flexion Active Range of Motion (AROM)
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Performance: 6 Minute Walk (6MW) Distance
Tidsram: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Functional Performance: Stair Climb Test
Tidsram: 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.
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Jennifer E. Stevens, MPT, PhD, University of Colorado, Denver
  • Huvudutredare: Michael Dayton, MD, University of Colorado, Denver
  • Huvudutredare: Wendy Kohrt, PhD, University of Colorado School of Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2008

Primärt slutförande (Faktisk)

1 februari 2011

Avslutad studie (Faktisk)

1 januari 2012

Studieregistreringsdatum

Först inskickad

27 juni 2008

Först inskickad som uppfyllde QC-kriterierna

2 juli 2008

Första postat (Uppskatta)

4 juli 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

10 juni 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 maj 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 06-0183
  • R03AR054538 (U.S.S. NIH-anslag/kontrakt)
  • 1R03AR054538-01A2 (U.S.S. NIH-anslag/kontrakt)

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Kliniska prövningar på Minimally Invasive Total Knee Arthroplasty [TKA Min]

3
Prenumerera