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)
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method — 10 years
Trial sites (3)
Facility
City
Region
Status
Cliniques Universitaires St-Luc UCL
Woluwe-Saint-Lambert
Brussels Capital
Hôpital Gabriel Montpied - Service de chirurgie Orthopédique
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.
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