Avenir Complete Post-Market Clinical Follow-Up Study

Zimmer Biomet

Status

Active, not recruiting

Conditions

Avascular Necrosis of Hip

Osteoarthritis, Hip

Post-traumatic; Arthrosis

Avascular Necrosis of the Femoral Head

Treatments

Device: Avenir Complete Femoral Stem

Study type

Interventional

Funder types

Industry

Identifiers

NCT04731077

CMG2020-20H

Details and patient eligibility

About

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.

Full 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).

Enrollment

275 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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;