N/A
Completed N=213
A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
Source: ClinicalTrials.gov NCT00754520 ↗Enrolled (actual)
213
Serious AEs
34.6%
Results posted
Oct 2024
Primary outcomePrimary: Composite Clinical Success (CCS) Rate as Defined in the Protocol — 59; 63 Participants
Summary
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Clinical Success (CCS) Rate as Defined in the Protocol |
59; 63 | — |
| SECONDARY Oxford Hip Score |
22.7; 22.1; 37.3; 39.0; 45.0; 44.8 | — |
| SECONDARY Womac Score |
10.5; 11.5; 2.9; 2.4; 0.8; 0.7 | — |
| SECONDARY Metal Ion Concentrations in Blood |
-1.8; 1.9; 1.5; 17.5; 1.4; 18.8 | — |
| SECONDARY Survivorship |
99; 88 | — |
Eligibility Criteria
Inclusion Criteria
- Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
- Patients preoperative Harris Hip Score 70 points
- Previous prosthetic hip surgery
- Patients with significant co-morbidity - ASA IV - V
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Existing metal implant or fixation device
- Pregnancy
- Presence of symptomatic arthritis in other lower limb joints
Data sourced from ClinicalTrials.gov (NCT00754520). 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.