Avenir Complete Post-Market Clinical Follow-Up Study

NCT ID: NCT04731077

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2036-06-01

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.

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).

Conditions

Osteoarthritis, Hip; Avascular Necrosis of Hip; Avascular Necrosis of the Femoral Head; Post-traumatic; Arthrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avenir Complete Femoral Stem

All enrolled subjects receive the study implant

Group Type: OTHER

Avenir Complete Femoral Stem

Intervention Type: DEVICE

All enrolled subjects will receive the Avenir Complete Femoral Stem

Interventions

Avenir Complete Femoral Stem

All enrolled subjects will receive the Avenir Complete Femoral Stem

Intervention Type: DEVICE

Eligibility 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;

• 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;

• 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;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mississippi Sports Medicine and Orthopaedic Center PLLC

Jackson, Mississippi, United States

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

Saint Joseph, Missouri, United States

Orthopedic & Fracture Clinic, PC

Portland, Oregon, United States

Copenhagen University Hospital, Hvidovre

Copenhagen, , Denmark

Nissan Tamagawa Hospital

Setagaya-Ku, Tokyo, Japan

Okayama City Hospital

Okayama, , Japan

Ikazia Ziekenhuis

Rotterdam, South Holland, Netherlands

Sykehuset Innlandet HF

Tynset, , Norway

Sahlgrenska University Hospital - Molndal

Mölndal, , Sweden

Countries

United States; Denmark; Japan; Netherlands; Norway; Sweden

Other Identifiers

CMG2020-20H

Identifier Type: -

Identifier Source: org_study_id