Avenir® Cemented Hip Stem - PMCF

NCT03396224 | Active Not Recruiting

• 1 other identifier: CME2013-03H
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Primary Osteoarthritis; Post-Traumatic Osteoarthritis of Hip; Femoral Neck Fractures; Femoral Head Necrosis; Sequelae From Previous Hip Surgery; Osteotomies; Congenital Hip Dysplasia

Keywords

Total hip arthroplasty; Hip implant

Outcome Measures

Primary Outcomes (1)

• Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method

  10 years

Secondary Outcomes (4)

• The results of the hip surgery will be determined by the Harris Hip Score

  10 years

• The patient's quality-of-life will be determined by the EQ-5D score

  10 years

• Abnormalities determined on X-rays in the bone region surrounding the implant will be reported

  10 years

• Number of patient with adverse events related to the implant will be reported

  10 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who: * are in need of a primary total hip arthroplasty * receive the Avenir® Cemented Hip Stem and compatible femoral head and acetabular cup * meet all the inclusion criteria and none of the exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• Patient is unwilling or unable to give consent, or to comply with the follow-up program.
• 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., stainless steel).
• Local bone tumors and/or cysts.
• Pregnancy
• Skeletal immaturity
• 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.
• Patients with plans to relocate during the study follow-up period.
• For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Cliniques Universitaires St-Luc UCL

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Hôpital Gabriel Montpied - Service de chirurgie Orthopédique

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003, France

Location

Hopital Lapeyronie - Service Orthopédie

Montpellier, Occitanie, 34295, France

Location

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 10, 2018
• Study Start: November 18, 2015
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

BE (1); FR (2)