Last updated on September 2018

Avenir Cemented Hip Stem - PMCF

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03396224

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Recruitment Status: Open

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