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10003 PRO Current Products (10003)

19. April 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

842

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

22 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
CR FB
Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration
Gerät: 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
Gerät: 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
Gerät: 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
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluate the psychometric properties of PKIP
Zeitfenster: 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
Zeitfenster: < 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: < 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

DePuy Orthopaedics

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2011

Primärer Abschluss (Tatsächlich)

10. August 2018

Studienabschluss (Tatsächlich)

10. August 2018

Studienanmeldedaten

Zuerst eingereicht

20. Dezember 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Dezember 2011

Zuerst gepostet (Schätzen)

22. Dezember 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 10003

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