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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411044
• Other study ID #: 09H06
• Status: Completed
• Start date: February 8, 2008
• Est. completion date: August 10, 2023

Study information

• Verified date: August 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: August 10, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Prosthesis Failure
• Rheumatoid Arthritis

Intervention

Device:
• Fitmore Hip Stem

Locations

Country	Name	City	State
Germany	Auguste Viktoria Klinik	Bad Oeynhausen
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Italy	Clinica San Michele	Albenga
Switzerland	Kantonsspital Graubünden	Chur
United Kingdom	The Yorkshire Clinic	Bingley	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirm safety of the Fitmore stem by monitoring the frequency and incidence of adverse events		10 years
Primary	Confirm performance of the Fitmore stem based on the survivorship of the implant at 10 years based on number of revisions		10 years