Frontlight ResearchEarly access
Active, not recruitingNo phase
Avenir® Cemented Hip Stem - PMCF
Key facts
- Who runs it
- Zimmer Biomet
- Where
- Belgium and France3 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 100 people enrolled
- Started
- 18 Nov 2015
- Expected to end
- Nov 2030
- Type of study
- Observational
- Record updated
- 25 November 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patient is 18 years of age minimum
- Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history
- Patient is willing and able to cooperate in the required post-operative therapy
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent
Who cannot take part
- 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
- 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., stainless steel)
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them
- For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated
- Patient is unwilling or unable to give consent, or to comply with the follow-up program
- Total or partial absence of the muscular or ligamentous apparatus
- Local bone tumors and/or cysts
- Pregnancy
- Skeletal immaturity
- Patients with plans to relocate during the study follow-up period
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
The group in the trial
- Patients who received the Avenir® Cemented Hip Stem
Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem
- Record updated
- 25 November 2025