Active — Not RecruitingNot Applicable

Avenir Complete Post-Market Clinical Follow-Up Study

United States, Denmark, Japan275 participantsStarted 2021-09-27

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, chron…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival of the study device; whether or not it is still implanted in the subject

Timeframe: 10 years

Trial details

NCT IDNCT04731077

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2035-06-01

View on ClinicalTrials.gov More Osteoarthritis, Hip trials

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.