Long-term follow-up of the Avenir Complete hip implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the long-term safety, performance, and clinical benefits of the Avenir Complete femoral stem used in various hip surgeries, including total, hemi, and revision arthroplasty. The primary endpoint focuses on the survival of the implant system over a 10-year period, assessed through the Kaplan Meier method. Safety will be monitored by tracking adverse events related to the implant and procedure, while secondary endpoints will include patient-reported outcomes and radiographic assessments. The study involves patients who have experienced joint deterioration or previous hip surgery failures.

Why it matters

Who can join: the full rules

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;

Where it's running

• Sykehuset Innlandet HF
  Tynset, Norway Recruiting
• Sahlgrenska University Hospital - Molndal
  Molndal, Sweden Recruiting
• Mississippi Sports Medicine and Orthopaedic Center PLLC
  Jackson, Mississippi, United States Active not recruiting
• Heartland Regional Medical Center d.b.a. Mosaic Life Care
  Saint Joseph, Missouri, United States Active not recruiting
• Orthopedic & Fracture Clinic, PC
  Portland, Oregon, United States Active not recruiting
• Copenhagen University Hospital, Hvidovre
  Copenhagen, Denmark Active not recruiting

Study contacts

• Study coordinator: Lisette Smid, PhD
• Email: lisette.smid@zimmerbiomet.com
• Phone: +31 62 395 6378

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.