N/A
N=126
A Five-Year Metal-on-Metal Retrospective Clinical Study
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01481896 ↗Enrolled (actual)
126
Serious AEs
9.2%
Results posted
Oct 2013
Primary outcome: Primary: Metal Ion Levels Per Participant — 1.4; 2.1 micrograms per liter
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Metal-on-metal primary total hip arthroplasty (DePuy ) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anderson Orthopaedic Research Institute
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metal Ion Levels Per Participant |
1.4; 2.1 | — |
| SECONDARY Cup Orientation Per Hip |
39; 19 | — |
| SECONDARY Harris Hip Score Per Hip |
95 | — |
| SECONDARY Osteolysis Per Hip |
3; 2 | — |
| SECONDARY Implant Stability Per Hip |
105; 108; 2; 0; 1; 0 | — |
| SECONDARY Component Revision Per Hip |
1; 2; 1 | — |
| SECONDARY Patient Satisfaction Per Hip |
106; 0 | — |
Summary
This retrospective study will review the Anderson Orthopaedic Institute's initial experience among a consecutive series of 126 patients who had primary total hip arthroplasty using a metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Primary total hip arthroplasty patients who had surgery between April 2001 and November 2002 who were implanted with a Pinnacle acetabular cup, an Ultamet metal-on-metal insert and a 36mm cobalt-chrome alloy femoral head
Exclusion Criteria
- Revision total hip arthroplasties
- Primary total hip arthroplasties using Ultamet liners coupled with 28-mm femoral heads
Data sourced from ClinicalTrials.gov (NCT01481896). 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.