- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00983762
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:
- Patients requiring primary knee arthroplasty;
- Knee osteoarthritis;
- Subject has sufficient quantity or quality of bone support;
- Subject has no previous or active infection in the affected joint or systemic infection;
- Subject judged to be available for follow-up through at least 1 year postoperative;
- All subjects in arthroplasty groups will be between 50-70 years of age
Healthy subjects:
- Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
- All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
- All healthy persons will be 40-70 years.
Exclusion Criteria:
- Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
- Unable to return for follow up x-rays and clinical evaluation;
- Unable to comprehending study protocol for any reason;
- Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
- 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;
- 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.
Sponsor
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
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007P001220
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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