NCT03396224

Avenir® Cemented Hip Stem - PMCF

Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2. The objectives of this study are to confirm the safety and performance of the Avenir Cemented Hip Stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively. The Avenir Cemented Hip Stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the Avenir-Mueller Stem. Safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review. Performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the Avenir® Cemented Hip stem. Implant survival will be based on removal or intended removal of the device. A total of 130 patients will be enrolled into the study at up to 4 sites.

Conditions

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

Timeline

• Start date: 2015-11-18
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2018-01-10
• Last updated: 2025-11-25

Locations

3 sites across 2 countries: Belgium, France