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

Study Overview
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Brief Summary
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A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.

Detailed Description
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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. Targeted Number of Subjects: 500. Data Collection: Collection of preoperative, intra-operative and immediate post-operative data; follow-up visits at 6-12 weeks, 1, 2, 3, 5, 7 and 10 years post-operatively. Recruitment period: 24 months. Clinical Assessments: Evaluations will be made using the Harris Hip Score, the Oxford Hip Score, the SF-12 Physical and Mental Health summary measures, the EQ-5D (EuroQol) and radiographically. Safety Assessments: Safety will be assessed by appropriate recording and reporting of adverse events throughout the study. The Fitmore Hip Stem is CE marked, commercially available and has been pre-clinically tested.

Official Title
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Fitmore Hip Stem Post-Market Clinical Follow-Up (PMCF) Study

Conditions
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Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Prosthesis Failure

Intervention / Treatment
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* Device: Fitmore Hip Stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are capable of understanding the doctors 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with a Fitmore Hip Stem<br>Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem | Device: Fitmore Hip Stem<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm safety of the Fitmore stem by monitoring the frequency and incidence of adverse events |  | 10 years | 
| Confirm performance of the Fitmore stem based on the survivorship of the implant at 10 years based on number of revisions |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, Fitmore, Minimal Invasive Surgery, Short Stem