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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