NCT03411044

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 420 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Prosthesis Failure

Interventions

Type	Name	Description
DEVICE	Fitmore Hip Stem

Timeline

• Start date: 2008-02-08
• Primary completion: 2023-06-10
• Completion: 2023-06-10
• First posted: 2018-01-25
• Last updated: 2024-11-05
• Results posted: 2024-10-17

Locations

5 sites across 4 countries: Germany, Italy, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study