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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