Avenir Complete Post-Market Clinical Follow-Up Study
Running, not enrolling · Not applicable
Conditions studied: Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head, Post-traumatic; Arthrosis
In brief
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.
Key facts
- Study ID
- NCT04731077
- Run by
- Zimmer Biomet
- People needed
- 275
- Starts
- 2021-09-27
- Expected to finish
- 2036-06-01
- Last updated by the study team
- 2025-06-18
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- 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
Full record on ClinicalTrials.gov
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