← Back to all trials
Active Not Recruiting
NCT04731077
Avenir Complete Post-Market Clinical Follow-Up Study
Conditions: Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head, Post-traumatic; Arthrosis
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 275
Sponsor: Zimmer Biomet
Location: Mississippi Sports Medicine and Orthopaedic Center PLLC Jackson Mississippi
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.
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;
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;
Source: ClinicalTrials.gov (NCT04731077). StuddyBuddy aggregates publicly available trial information.