N/A
Completed N=379
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
Osteoarthritis · Post-traumatic Osteoarthritis of Hip Nos · Femur Head Necrosis · Femur Neck Fracture
Source: ClinicalTrials.gov NCT02062450 ↗
Enrolled (actual)
379
Serious AEs
2.5%
Results posted
May 2016
Primary outcomePrimary: Number of Participants With an Implant Dislocation After Surgery — 2 participants
Summary
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Implant Dislocation After Surgery |
2 | — |
| PRIMARY Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate) |
0.53 | — |
| PRIMARY Implant Survivorship |
99.5 | — |
| SECONDARY Clinical Performance - PMA Score |
10.8; 9.3; 16.4; 15.2; 6.1; 5.9 | — |
| SECONDARY Clinical Performance - HOOS Score |
91.8; 86.4; 87.5; 84.5; 84.2; 76.6 | — |
| SECONDARY Clinical Performance - HARRIS Score |
64; 40; 13; 16; 10; 19 | — |
Eligibility Criteria
Inclusion Criteria
- men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011,
- capable of attending the 2-year follow-up visit;
- capable of understanding the information about the study and agreeing to take part in it.
Exclusion Criteria
- patients with tumoral pathology.
Data sourced from ClinicalTrials.gov (NCT02062450). 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. Informational only — not medical advice.