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Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty

4. november 2009 opdateret af: Massachusetts General Hospital

Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty: The Minimally Invasive Surgery Mini-Incision (MIS) TKA, Standard Para-Patellar Surgery TKA and the Unicompartmental Knee Arthroplasty

A functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. A variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. The study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

12

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

TKA subjects:

Subjects will be selected and recruited from the MGH Arthroplasty Clinic. The surgical decision for TKA approach will be made prior to recruitment for the study.

Healthy persons:

Healthy subjects will be recruited through orthopedic departmental advertisement flyers and by word of mouth.

Beskrivelse

Inclusion Criteria:

  • TKA subjects:

    1. Patients requiring primary knee arthroplasty;
    2. Knee osteoarthritis;
    3. Subject has sufficient quantity or quality of bone support;
    4. Subject has no previous or active infection in the affected joint or systemic infection;
    5. Subject judged to be available for follow-up through at least 1 year postoperative;
    6. All subjects in arthroplasty groups will be between 50-70 years of age
  • Healthy subjects:

    1. Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
    2. All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
    3. All healthy persons will be 40-70 years.

Exclusion Criteria:

  1. Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
  2. Unable to return for follow up x-rays and clinical evaluation;
  3. Unable to comprehending study protocol for any reason;
  4. Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
  5. Subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include Subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), Subjects receiving therapy to prevent homograft rejection, Subjects who have a documented history of acquired immunodeficiency syndrome (AIDS), or auto-immune diseases;
  6. Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
MIS knee arthroplasty
Persons scheduled for Minimally Invasive Surgery Mini-Incision (MIS) Total Knee Arthroplasty (TKA)
Unicompartmental knee arthroplasty
Persons scheduled for Unicompartmental knee arthroplasty
Standard knee arthroplasty
Persons scheduled for Standard Para-patellar surgery TKA
Heathly knee subjects
Persons with healthy knees

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Isokinetic and isometric quadriceps and hamstring strength
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years

Sekundære resultatmål

Resultatmål
Tidsramme
American Academy Orthopaedic Surgeons Knee Score
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
University California Los Angeles Activity Score
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Timed "Up & Go" Test
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Sit to Stand to Sit (STSTS) Test
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Stair Test
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Visual Analog Pain Scale
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Knee adductor moment during gait and chair rise
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Knee loading pattern during gait & chair rise
Tidsramme: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Henrik Malchau, PhD, MD, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2009

Primær færdiggørelse (Forventet)

1. januar 2020

Studieafslutning (Forventet)

1. januar 2020

Datoer for studieregistrering

Først indsendt

23. september 2009

Først indsendt, der opfyldte QC-kriterier

23. september 2009

Først opslået (Skøn)

24. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. november 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2009

Sidst verificeret

1. november 2009

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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