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Survivance de la prothèse totale de genou primaire Attune

2 novembre 2026 mis à jour par: DePuy International

Survie à court, moyen et long terme de la prothèse primaire de genou Attune

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).

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.

This study allowed for enrolment into the study by two methods. The first method was by enroling subjects to receive the implant under study with the expectation to follow them out to 15 years. The second method was done to offset follow-up attrition. The second method allowed additional interested sites that had previously participated in a two-year follow-up study (NCT01746524) on this implant (subjects implanted and followed for two years) to reconsent interested subjects to be further followed out to 15 years in this study. The original 29 sites enroled 1232 subjects. Adding of the interested sites from the 2-yr follow-up study (NCT01746524) increased the sites from 29 to 37 sites. As of the last study update, the current enrolment is now1538.

Type d'étude

Interventionnel

Inscription (Réel)

1542

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Heidelberg, Allemagne, 69118
        • UniversitatsKlinikum Heidelberg
    • Bavaria
      • Bad Abbach, Bavaria, Allemagne, 3077
        • Orthopädische Klinik für die Universität Regensburg
  • Australie
    • South Australia
      • Adelaide, South Australia, Australie, ACT 2600
        • Canberra Hospital-Trauma & Orthopaedic Research Unit
  • Belgique
      • Antwerp, Belgique, 2100
        • Monica Camputs O.L.V. Middelares
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University of Western Ontario-Department of Orthopaedic Surgery
  • Corée du Sud
      • Seoul, Corée du Sud, 110-714
        • Seoul National University Hospital
    • Dongjak-gu
      • Seoul, Dongjak-gu, Corée du Sud, 156-707
        • Seoul National University Boramae Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • L'Autriche
    • Lower Austria
      • Vienna, Lower Austria, L'Autriche, 1090
        • Univ.-Klinik für Orthopädie
    • Upper Austria
      • Linz, Upper Austria, L'Autriche, 4010
        • Krankenhaus der Barmherzigen
  • Malaisie
      • Kuala Lumpur, Malaisie, 59100
        • University Malaya Medical Centre
  • Nouvelle-Zélande
      • Auckland, Nouvelle-Zélande
        • Ascot Hospital
  • Royaume-Uni
      • Harlow, Royaume-Uni, CM20 1QX
        • Princess Alexandria Hospital
      • York, Royaume-Uni, YO30 5RA
        • Clifton Park NHS Treatment Centre
    • Fife
      • Dunfermline, Fife, Royaume-Uni, KY12 OSU
        • Queen Mary Hospital
    • Oswestry
      • Gobowen, Oswestry, Royaume-Uni, SY10 7AG
        • Robert Jones & Agnes Hunt Orthopaedic Hospital
    • Scotland
      • Edinburgh, Scotland, Royaume-Uni, EH16 4SA
        • New Royal Infirmary of Edinburgh
  • Singapour
      • Singapore, Singapour, 169608
        • Singapore General Hospital-Dept of Orthopaedic Surgery
  • États-Unis
    • Arizona
      • Scottsdale, Arizona, États-Unis, 85259
        • Mayo Clinic Arizona
    • California
      • Orange, California, États-Unis, 92868
        • Orthopaedic Specialty Institute
    • Florida
      • DeLand, Florida, États-Unis, 32720
        • Florida Research Associates, LLC
    • Indiana
      • Mooresville, Indiana, États-Unis, 46158
        • Center for Hip and Knee Surgery
    • Iowa
      • Iowa City, Iowa, États-Unis, 52242
        • University of Iowa Hospitals & Clinics
    • Ohio
      • Columbus, Ohio, États-Unis, 43213
        • Orthopedic One
      • New Albany, Ohio, États-Unis, 43054
        • OrthoNeuro
    • Pennsylvania
      • Hershey, Pennsylvania, États-Unis, 17033
        • Penn State Hershey Bone & Joint Institute
    • Texas
      • Austin, Texas, États-Unis, 78705
        • Texas Institute for Hip and Knee Surgery, LLC

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

22 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.
  • Subject was diagnosed with NIDJD.
  • Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
  • Subject is currently not bedridden.
  • Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
  • Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
  • The devices specified in this protocol were implanted.

Exclusion Criteria:

  • 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 (unilateral, 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 erythematosis, etc.).
  • Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
  • Subject has a medical condition with less than 5 years of life expectancy.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Attune Primary Total Knee Replacement

Subjects will receive one of the following Attune total knee implants:

Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)
Dispositif: Attune Primary Total Knee Replacement

Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Survivorship of each configuration.
Délai: Minimum 15 years (5414 - 5658 days)

Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
Minimum 15 years (5414 - 5658 days)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Survivorship
Délai: Minimum 5 years (1764 - 3588 days)

Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
Minimum 5 years (1764 - 3588 days)
Survivorship
Délai: Minimum 10 years (3589 - 5413 days)

Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
Minimum 10 years (3589 - 5413 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
Délai: Minimum 1 year (304 - 668 days)

Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Minimum 1 year (304 - 668 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
Délai: Minimum 2 years (669 - 1763 days)

Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Minimum 2 years (669 - 1763 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
Délai: Minimum 5 years (1764 - 3588 days)

Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Minimum 5 years (1764 - 3588 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
Délai: Minimum 10 years (3589 - 5413 days)

Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Minimum 10 years (3589 - 5413 days)
Implant fixation: Radiographic assessment of bone-implant interface performance
Délai: Minimum 15 years (5414 - 5658 days)

Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Minimum 15 years (5414 - 5658 days)
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Patient-reported Outcome: Oxford Knee Score
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likert-lie response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.
Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and includes the WOMAC Osteoarthritis index. 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.
Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

The Pre Surgical and/or 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 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Patient-reported Outcome: Knee Society Score
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). Likert responses are used, typically with five response options.
Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Evaluate the impact of surgeon learning curve on clinical and functional outcomes
Délai: <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

A surgeon learning curve will be investigated by comparing learning curve cases (the pooled cohort of each surgeon's first 10 study Subjects) with all investigational Subjects. All primary and secondary outcomes will be compared across the learning curve and post-learning curve Subject cohorts.
<1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Evaluate changes in femoral component and tibial component alignment
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Délai: Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

DePuy International

Les enquêteurs

  • Directeur d'études: Allyson Morris, DePuy Synthes

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2013

Achèvement primaire (Estimé)

1 février 2030

Achèvement de l'étude (Estimé)

1 février 2030

Dates d'inscription aux études

Première soumission

18 décembre 2012

Première soumission répondant aux critères de contrôle qualité

18 décembre 2012

Première publication (Estimé)

21 décembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10008

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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