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Clinical Trials in the USA / NCT04731077
Active, not recruiting Not applicable

Avenir Complete Post-Market Clinical Follow-Up Study

NCT04731077 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2021-09-27
Last updated
2025-06-18

Condition(s) studied

Osteoarthritis, HipAvascular Necrosis of HipAvascular Necrosis of the Femoral HeadPost-traumatic; Arthrosis

Investigational drug(s) / intervention(s)

Avenir Complete Femoral Stem

Avenir Complete Femoral Stem: All enrolled subjects will receive the Avenir Complete Femoral Stem

Study 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

Sex
ALL
Min age
20 Years
Max age
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Mississippi Sports Medicine and Orthopaedic Center PLLC Jackson Mississippi
Heartland Regional Medical Center d.b.a. Mosaic Life Care Saint Joseph Missouri
Orthopedic & Fracture Clinic, PC Portland Oregon
Copenhagen University Hospital, Hvidovre Copenhagen Denmark
Nissan Tamagawa Hospital Setagaya-Ku Tokyo
Okayama City Hospital Okayama Japan
Ikazia Ziekenhuis Rotterdam South Holland
Sykehuset Innlandet HF Tynset Norway
Sahlgrenska University Hospital - Molndal Mölndal Sweden

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04731077 on ClinicalTrials.gov ↗ ← All trials in the USA