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NCT04731077 | RECRUITING | Osteoarthritis, Hip

Avenir Complete Post-Market Clinical Follow-Up Study
Sponsor:

Zimmer Biomet

Brief 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.

Condition or disease

Osteoarthritis, Hip

Avascular Necrosis of Hip

Avascular Necrosis of the Femoral Head

Post-traumatic; Arthrosis

Intervention/treatment

Avenir Complete Femoral Stem

Phase

NA

Detailed 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
Actual Study Start Date : 2021-09-27
Estimated Primary Completion Date : 2035-06-01
Estimated Study Completion Date : 2036-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 his instructions, able and willing to participate in the follow-up program and who gave consent 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 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 his instructions, able and willing to participate in the follow-up program and who gave consent 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 the implant 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 the implant;
  • * 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 study entails
    • * 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 unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate;
Avenir Complete Post-Market Clinical Follow-Up Study

Location Details

NCT04731077

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

United States, Mississippi

Mississippi Sports Medicine and Orthopaedic Center PLLC

Jackson, Mississippi, United States, 39202

ACTIVE NOT RECRUITING

United States, Missouri

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

Saint Joseph, Missouri, United States, 64506

ACTIVE NOT RECRUITING

United States, Oregon

Orthopedic & Fracture Clinic, PC

Portland, Oregon, United States, 97225

ACTIVE NOT RECRUITING

Denmark,

Copenhagen University Hospital, Hvidovre

Copenhagen, Denmark, DK-2650

ACTIVE NOT RECRUITING

Japan, Tokyo

Nissan Tamagawa Hospital

Setagaya Ward, Tokyo, Japan, 410-0302

ACTIVE NOT RECRUITING

Japan,

Okayama City Hospital

Okayama, Japan, 700-0962

ACTIVE NOT RECRUITING

Netherlands, South Holland

Ikazia Hospital

Rotterdam, South Holland, Netherlands, 3083 AN

RECRUITING

Norway,

Innlandet Hospital HF

Thinned, Norway, 2500

RECRUITING

Sweden,

Sahlgrenska University Hospital - Molndal

Molndal, Sweden, 43180