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Predictive Factors for Revision and Survivorship Analysis of a Prevalent 36-mm Metal-on-Metal Total Hip Replacement
Oliver Pearce1, Gulraj S Matharu2, Ben J Bolland3
1Department of Orthopaedic Surgery, Southmead Hospital, Bristol, United Kingdom.
Insights
This study found a high 10-year failure rate for the Corail-Pinnacle metal-on-metal hip system, with female gender and high-offset stems predicting revision. Manufacturing variations did not significantly increase revisions after 2007.
Area of Science:
- Orthopedic Surgery
- Biomaterials Science
- Medical Device Analysis
Background:
- The Corail-Pinnacle 36-mm metal-on-metal total hip replacement system is analyzed in the largest single-center cohort to date.
- Concerns regarding manufacturing variations in shells produced after 2006 prompted an investigation into their impact on implant wear and revision rates.
Purpose of the Study:
- To determine the 10-year survivorship of the Corail-Pinnacle 36-mm metal-on-metal total hip replacement system.
- To identify patient and implant-related predictors of revision surgery.
- To assess the influence of the year of implantation on revision risk, particularly concerning manufacturing variations.
Main Methods:
- A cohort of 1212 Corail-Pinnacle 36-mm metal-on-metal total hip replacements implanted between 2005 and 2012 was retrospectively analyzed.
- Kaplan-Meier survival analysis, Cox regression, and interrupted time series analysis were employed to evaluate revision risk.
- Patient demographics, implant characteristics (including cup diameter and stem type), and year of implantation were assessed as potential predictors of revision.
Main Results:
- The 10-year survival rate was 83.4%, with 9.8% of patients requiring revision surgery, primarily due to adverse reactions to metal debris.
- Significant predictors of revision included female gender (HR=1.608), younger age at implantation (HR=0.982), smaller cup diameter (50-54 mm, HR=1.527), and high-offset stems (HR=2.573).
- Multivariate analysis confirmed female gender and high-offset stems as significant predictors. No statistically significant increase in revisions was observed for components implanted after 2007 compared to those implanted before.
Conclusions:
- The Corail-Pinnacle 36-mm metal-on-metal total hip replacement system demonstrated a high 10-year failure rate (16.6%), largely attributed to adverse reactions to metal debris.
- Female gender and high femoral offset stems are significant predictors of all-cause revision.
- While year of implantation did not show a significant association with increased revisions from 2007 onwards, further research into manufacturing discrepancies is recommended.
Background:
To our knowledge, this is the largest single-center cohort of the 36-mm Corail-Pinnacle metal-on-metal total hip replacements system, aiming to determine 10-year survivorship and identify predictors of revision. We further assessed year of implantation given reports of manufacturing variations affecting shells made after 2006 predisposing these components to increasing wear.
Methods:
All Corail-Pinnacle 36-mm metal-on-metal hips implanted in a single center (2005-2012). The effect of patient and implant-related variables, and year of implantation on revision risk was assessed using Kaplan-Meier, Cox regression, and interrupted time series analysis.
Results:
In total, 1212 metal-on-metal total hip replacements were implanted with a 10-year survival rate of 83.4% (95% confidence interval [CI] = 81.3-85.5). Mean follow-up duration was 7.3 years with 61% of patients reaching a minimum of 7 years of follow-up. One hundred nineteen patients required revision surgery (9.8%). Univariate analysis identified female gender (hazard ratio [HR] = 1.608, CI = 1.093-2.364, P = .016), age at implantation (HR = 0.982, CI = 0.968-0.997, P = .019), smaller 50-mm to 54-mm cup diameter (HR = 1.527, CI = 1.026-2.274, P = .037), and high-offset stems (HR = 2.573, CI = 1.619-4.089, P < .001) as predictors of revision. Multivariate modeling confirmed female gender and high-offset stems as significant predictors of revision. For components implanted after 2007, the number of revisions showed no statistically significant step increase compared to pre-2007 implantation.
Conclusion:
We observed a high 10-year failure rate (16.6%) with this implant, mostly due to adverse reaction to metal debris. Female gender and high femoral offset stems were significant predictors for all-cause revision. Year of implantation was not significantly associated with an increasing number of revisions from 2007 onwards, although further studies to validate the impact of manufacturing discrepancies are recommended.
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