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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;

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04731077). StuddyBuddy aggregates publicly available trial information.