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

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis; Prosthesis Failure; Avascular Necrosis; Rheumatoid Arthritis

Treatments: Device: Fitmore Hip Stem

Study type: Observational

Funder types: Industry

Identifiers

NCT03411044

09H06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

420 participants in 1 patient group

Subjects with a Fitmore Hip Stem

Description:

Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.

Treatment:

Device: Fitmore Hip Stem