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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411044
Other study ID # 09H06
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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