N/A
N=420
Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.
Osteoarthritis · Avascular Necrosis · Rheumatoid Arthritis · Prosthesis Failure
Bottom Line
View on ClinicalTrials.gov: NCT03411044 ↗Enrolled (actual)
420
Serious AEs
9.5%
Results posted
Oct 2024
Primary outcome: Primary: Harris Hip Score — 50.0; 80.6; 94.5; 94.5 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fitmore Hip Stem (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Harris Hip Score |
50.0; 80.6; 94.5; 94.5; 94.2; 93.5 | — |
| PRIMARY Radiographic Evaluations |
2; 1 | — |
| PRIMARY Survivorship |
96.85 | — |
| SECONDARY EQ5D |
0.4; 0.8; 0.9; 0.9; 0.9; 0.9 | — |
| SECONDARY SF-12 Physical and Mental Functional Scores |
27.1; 39.1; 49.5; 50.0; 48.9; 50.3 | — |
| SECONDARY Oxford Hip Score |
19.3; 36.2; 42.8; 43.5; 43.3; 43.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03411044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.