Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

10003 PRO Current Products (10003)

19. april 2019 oppdatert av: DePuy Orthopaedics

Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations from different manufacturers will be pooled to establish a contemporary dataset.

The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS).

Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

Studietype

Observasjonsmessig

Registrering (Faktiske)

842

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia, 2077
        • Hornsby Ku-Ring-Gai Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Wakefield Orthopedic Clinic
    • Western Australia
      • Crawley, Western Australia, Australia, 6009
        • Freemantle Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Forente stater
    • California
      • Orange, California, Forente stater, 92868
        • Orthopaedic Specialty Institute
      • San Diego, California, Forente stater, 92103
        • UCSD Medical Center
    • Colorado
      • Fort Collins, Colorado, Forente stater, 80525
        • Orthopaedic Center of the Rockies
    • Florida
      • Jacksonville, Florida, Forente stater, 32205
        • Heekin Institute for Orthopedic Research
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40215
        • The Arthroplasty Foundation
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane University Hospital and Clinic
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Hip and Knee Research of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
    • Ohio
      • Columbus, Ohio, Forente stater, 43213
        • Cardinal Orthopaedic Institute
    • Virginia
      • Alexandria, Virginia, Forente stater, 22307-9804
        • Anderson Orthopaedic Research Institute
    • Washington
      • Seattle, Washington, Forente stater, 98122-5330
        • Swedish Orthopedic Institute
  • New Zealand
      • Auckland, New Zealand
        • Ascot Hospital
  • Storbritannia
      • Harlow, Storbritannia, CM20 1QX
        • Princess Alexandra Hospital
      • Llandough, Storbritannia, CF64 2XX
        • University Hospital Llandough
      • Middlesborough, Storbritannia, TS4 3BW
        • James Cook University Hospital
      • York, Storbritannia, YO30 5RA
        • Clifton Park NHS Treatment Centre
    • Fife
      • Dunfermline, Fife, Storbritannia, KY12 OSU
        • Queen Margaret Hospital
    • Surrey
      • Guildford, Surrey, Storbritannia, GU2 7XX
        • The Royal Surrey County Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

22 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Male and female Subjects with Non-inflammatory Degenerative Joint Disease (NIDJD) who require primary TKA with one of several designated knee systems currently on the market and are aged 22 to 80 years, inclusive.

Beskrivelse

Inclusion Criteria:

  • Subject is male or female and between the ages of 22 and 80 years, inclusive.
  • Subject was diagnosed with NIDJD.
  • Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either a resurfaced or non-resurfaced patellae.
  • Subject's TKA device was one of the total knee prostheses described under Interventions.
  • Subject is currently not bedridden.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation, is willing and able to perform all study procedures and follow-up visits and has authorized the transfer of his/her information to DePuy.
  • Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  • Subject must be comfortable with speaking, reading, and understanding questions and providing responses in English.
  • The devices specified in this CIP were implanted.

Exclusion Criteria:

  • The Subject is a woman who is pregnant or lactating.
  • Contralateral knee has already been enrolled in this study.
  • Subject had a contralateral amputation.
  • Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
  • Subject is currently experiencing radicular pain from the spine.
  • Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
  • Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
  • Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
  • Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
  • Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  • Subject has a medical condition with less than 2 years of life expectancy.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
CR FB
Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration
Enhet: Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
PS FB
Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration
Enhet: Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
CR RP
Subjects receiving a Cruciate Retaining Rotating Platform implant configuration
Enhet: Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
PS RP
Subjects receiving a Posterior Stabilized Rotating Platform implant configuration
Enhet: Total Knee Replacement

Subjects will receive one of the following total knee implants:

PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score
Tidsramme: up to one year
The primary endpoint will be measuerd before surgery and out to a minimum of 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
up to one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate the psychometric properties of PKIP
Tidsramme: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
The Pre and Post-Surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate the longitudinal functional performance of primary TKA
Tidsramme: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate Incidence of Anterior Knee Pain
Tidsramme: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate incidence of asymptomatic and symptomatic crepitus
Tidsramme: Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees
Tidsramme: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

DePuy Orthopaedics

Etterforskere

  • Studieleder: Ahmad S. Ismail, MS, CCRP, DePuy Orthopaedics

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2011

Primær fullføring (Faktiske)

10. august 2018

Studiet fullført (Faktiske)

10. august 2018

Datoer for studieregistrering

Først innsendt

20. desember 2011

Først innsendt som oppfylte QC-kriteriene

21. desember 2011

Først lagt ut (Anslag)

22. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 10003

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere