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Clinical Trials in Belgium / NCT03396224
Active, not recruiting Observational

Avenir® Cemented Hip Stem - PMCF

NCT03396224 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2015-11-18
Last updated
2025-11-25

Condition(s) studied

Primary OsteoarthritisPost-Traumatic Osteoarthritis of HipFemoral Neck FracturesFemoral Head NecrosisSequelae From Previous Hip SurgeryOsteotomiesCongenital Hip Dysplasia

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Cliniques Universitaires St-Luc UCL Woluwe-Saint-Lambert Brussels Capital
Hôpital Gabriel Montpied - Service de chirurgie Orthopédique Clermont-Ferrand Auvergne-Rhône-Alpes
Hopital Lapeyronie - Service Orthopédie Montpellier Occitanie

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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 NCT03396224 on ClinicalTrials.gov ↗ ← All trials in Belgium