Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.

Launched by ZIMMER BIOMET · Jan 19, 2018

Keywords

ClinConnect Summary

The objective of this post market surveillance study is to obtain outcome data on the Fitmore 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.

The Fitmore Hip Stem is a short and curved uncemented stem that allows preservation of the greater trochanter and of the gluteal muscles.

Indication/Target Population: Patients suffering from severe hip pain and disability requiring total hip arthroplasty.

Study Design: A multi-centre, non-comparative, prospective post-marketing study.
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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who are capable of understanding the doctor"s explanations, following his instructions and who are able to participate in the follow-up program.
• • Patients who have given written consent to take part in the study by signing the "Patient Consent Form".
• • 18 years minimum.
• • Male and female.
• • Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.
• Exclusion Criteria:
• • Patients who are unwilling or unable to give consent or to comply with the follow-up program.
• • Pregnancy.
• • Patients who are skeletally immature.