Avenir Complete Post-Market Clinical Follow-Up Study

Last updated: March 8, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Musculoskeletal Diseases

Osteomyelitis

Treatment

Avenir Complete Femoral Stem

Clinical Study ID

NCT04731077
CMG2020-20H
  • Ages > 20
  • All Genders

Study Summary

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is at least 20 years old or older and skeletally mature.
  • Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
  • Failed previous hip surgery including
  • Joint reconstruction (osteotomy)
  • Arthrodesis
  • Hemi-arthroplasty or total hip replacement (THR)
  • Acute traumatic fracture of the femoral head or neck;
  • Avascular necrosis of the femoral head.
  • Patients capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program and who gaveconsent to take part in the study;

Exclusion

Exclusion Criteria:

  • Acute, chronic, local, or systemic infections;
  • Severe muscular, neural, or vascular diseases that endanger the limbs involved;
  • Lack of bony structures proximal or distal to the joint, so that good Inclusioncriteria
  • Patient is at least 20 years old or older and skeletally mature.
  • Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
  • Failed previous hip surgery including
  • Joint reconstruction (osteotomy)
  • Arthrodesis
  • Hemi-arthroplasty or total hip replacement (THR)
  • Acute traumatic fracture of the femoral head or neck;
  • Avascular necrosis of the femoral head.
  • Patients capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program and who gaveconsent to take part in the study; Exclusion criteria
  • Acute, chronic, local, or systemic infections;
  • Severe muscular, neural, or vascular diseases that endanger the limbs involved;
  • Lack of bony structures proximal or distal to the joint, so that good anchorage of theimplant is unlikely or impossible;
  • Total or partial absence of the muscular or ligamentous apparatus;
  • Any concomitant diseases that can jeopardize the functioning and the success of theimplant;
  • Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel,etc.);
  • Local bone tumors and/or cysts;
  • Pregnancy;
  • Skeletal immaturity.
  • Patients unwilling or unable to give consent, or to comply with the follow-up program;
  • Patients who have any condition that would - in the judgement of the Investigator -place him/her at undue risk or
  • interfere with the study;
  • Any vulnerable subject:
  • a prisoner
  • mentally incompetent or unable to understand what participation in the studyentails
  • a known alcohol or drug abuser
  • anticipated to be non-compliant
  • Patients with plans to relocate during the study follow-up period;
  • Individuals whose willingness to volunteer in a clinical investigation could be undulyinfluenced by the expectation, whether justified or not, of benefits associated withparticipation or of retaliatory response from senior members of a hierarchy in case ofrefusal to participate;

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Avenir Complete Femoral Stem
Phase:
Study Start date:
September 27, 2021
Estimated Completion Date:
June 01, 2036

Study Description

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty:

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

Connect with a study center

  • Copenhagen University Hospital, Hvidovre

    Copenhagen, DK-2650
    Denmark

    Site Not Available

  • Nissan Tamagawa Hospital

    Setagaya-Ku, Tokyo 410-0302
    Japan

    Site Not Available

  • Okayama City Hospital

    Okayama, 700-0962
    Japan

    Site Not Available

  • Ikazia Ziekenhuis

    Rotterdam, Zuid-Holland 3083 AN
    Netherlands

    Site Not Available

  • Sykehuset Innlandet HF

    Tynset, 2500
    Norway

    Active - Recruiting

  • Sahlgrenska University Hospital - Molndal

    Molndal, 43180
    Sweden

    Active - Recruiting

  • Mississippi Sports Medicine and Orthopaedic Center PLLC

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Heartland Regional Medical Center d.b.a. Mosaic Life Care

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Orthopedic & Fracture Clinic, PC

    Portland, Oregon 97225
    United States

    Site Not Available

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