Frontlight ResearchEarly access
Active, not recruitingNo phase
Avenir Complete Post-Market Clinical Follow-Up Study
Key facts
- Who runs it
- Zimmer Biomet
- Where
- Jackson, Portland, and Saint Joseph, United StatesSee the 3 sitesAlso in 5 other countries, 6 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 275 people enrolled
- Started
- 27 Sept 2021
- Expected to end
- 1 Jun 2036
- Type of study
- Interventional
- Treatments tested
- Avenir Complete Femoral Stem
- Record updated
- 13 October 2026
Who can take part
- Age
- 20 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- Failed previous hip surgery including; Joint reconstruction (osteotomy); Arthrodesis; Hemi-arthroplasty or total hip replacement (THR)
- Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible
- Any concomitant diseases that can jeopardize the functioning and the success of the implant
- 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
- Acute, chronic, local, or systemic infections
- Severe muscular, neural, or vascular diseases that endanger the limbs involved
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases
- Acute, chronic, local, or systemic infections
- Severe muscular, neural, or vascular diseases that endanger the limbs involved
- Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.)
- Patients who have any condition that would - in the judgement of the Investigator - place him/her at undue risk or
- Patient is at least 20 years old or older and skeletally mature
- Lack of bony structures proximal or distal to the joint, so that good Inclusion criteria
- 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
- Total or partial absence of the muscular or ligamentous apparatus
- Local bone tumors and/or cysts
- Pregnancy
- Skeletal immaturity
- Patients unwilling or unable to give consent, or to comply with the follow-up program
- interfere with the study
- 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 in United States
Also in 5 other countries, 6 sites
- Mississippi Sports Medicine and Orthopaedic Center PLLCJackson, United States
- Orthopedic & Fracture Clinic, PCPortland, United States
- Heartland Regional Medical Center d.b.a. Mosaic Life CareSaint Joseph, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Avenir Complete Femoral StemOther group
All enrolled subjects receive the study implant
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
- Record updated
- 13 October 2026