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

Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)

This study is testing how well the Avenir Complete hip implant works and stays safe for people who have had hip surgeries over a 10-year period.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (Industry-sponsored)
• Locations: 9 sites (Jackson, Mississippi and 8 other locations)
• Trial ID: NCT04731077 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients aged 20 and older with advanced joint wear or previous hip surgery failures.

Not a fit: Patients with acute or chronic infections, severe vascular diseases, or insufficient bone structure near the joint may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Avenir Complete hip implant, potentially improving patient outcomes in hip surgeries.

How similar studies have performed: Other studies on hip implants have shown promising results, indicating that this approach is supported by prior successful outcomes.

Eligibility criteria

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 this trial is running

Jackson, Mississippi and 8 other locations

• 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)
• Nissan Tamagawa Hospital — Setagaya-Ku, Tokyo, Japan (Active_not_recruiting)
• Okayama City Hospital — Okayama, Japan (Active_not_recruiting)
• Ikazia Ziekenhuis — Rotterdam, Zuid-Holland, Netherlands (Active_not_recruiting)
• Sykehuset Innlandet HF — Tynset, Norway (Recruiting)
• Sahlgrenska University Hospital - Molndal — Molndal, Sweden (Recruiting)

Study contacts

• Study coordinator: Lisette Smid, PhD

Conditions Osteoarthritis, Hip; Avascular Necrosis of Hip; Avascular Necrosis of the Femoral Head; Post-traumatic; Arthrosis