Avenir Müller Hip Stem Post Market Surveillance Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-09

Study Completion Date

2019-08-31

Brief Summary

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This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Müller Hip Stem.

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Detailed Description

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The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.

Conditions

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Osteoarthritis, Hip Rheumatoid Arthritis Fracture of Hip Dislocated Hip Osteonecrosis Post-traumatic; Arthrosis Subluxation Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients suffering from severe hip pain and disability

Patients in need of a total hip arthroplasty.

Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.

Intervention Type DEVICE

Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.

Interventions

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Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.

Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients able to participate in a follow-up program based upon physical examination and medical history.
* Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
* 18 years minimum.
* Male and female.
* Baseline data exist (pre-, peri- and immediate postoperative)