Rheumatoid Arthritis Clinical Trial
Official title:
Fitmore Hip Stem Post-Market Clinical Follow-Up (PMCF) Study
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 |
Verified date | August 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Germany, Italy, Switzerland, United Kingdom,
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 |
Status | Clinical Trial | Phase | |
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