N/A
N=132
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair
Hip Replacement · Primary, Secondary or Post-traumatic Osteoarthrosis · Femur Head Necrosis · Congenital Dislocations
Bottom Line
View on ClinicalTrials.gov: NCT02062437 ↗Enrolled (actual)
132
Serious AEs
1.3%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants With Adverse Events — 2 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Trauma and Extremities
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2 | — |
| SECONDARY General Performance: Mobility |
0; 107; 26; 34; 30; 21 | — |
| SECONDARY General Performance: Mobility |
0; 107; 26; 34; 30; 21 | — |
Summary
The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.
Eligibility Criteria
Inclusion Criteria
- Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
- Aged of more than 18 years at the time of the surgery.
- Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period.
- Able to understand information to participate to the study.
Exclusion Criteria
- Patient having a tumoral pathology.
- Patient having expressed opposition to the study participation.
Data sourced from ClinicalTrials.gov (NCT02062437). 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.