Status:
ACTIVE_NOT_RECRUITING
Avenir® Cemented Hip Stem - PMCF
Lead Sponsor:
Zimmer Biomet
Conditions:
Primary Osteoarthritis
Post-Traumatic Osteoarthritis of Hip
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
Detailed Description
This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2. Th...
Eligibility Criteria
Inclusion
- Patient is 18 years of age minimum.
- Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
- Patient is willing and able to cooperate in the required post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Exclusion
- Patient is unwilling or unable to give consent, or to comply with the follow-up program.
- 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., stainless steel).
- Local bone tumors and/or cysts.
- Pregnancy
- Skeletal immaturity
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them.
- Patients with plans to relocate during the study follow-up period.
- For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.
Key Trial Info
Start Date :
November 18 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03396224
Start Date
November 18 2015
End Date
November 1 2030
Last Update
November 25 2025
Active Locations (3)
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1
Cliniques Universitaires St-Luc UCL
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
2
Hôpital Gabriel Montpied - Service de chirurgie Orthopédique
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63003
3
Hopital Lapeyronie - Service Orthopédie
Montpellier, Occitanie, France, 34295