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The Performance of MAGEC X Spine Rods: A Comparative Retrieval Study
Martina Tognini1, Harry Hothi1, Sean Bergiers1
1The Royal National Orthopaedic Hospital and Institute of Orthopaedics and Musculoskeletal Science, University College London, Stanmore, UK.
Global Spine Journal
|April 21, 2022
Summary
The MAGEC X magnetically controlled growing rod (MCGR) showed performance comparable to the earlier MAGEC 1.3. While end-cap loosening occurred in MAGEC X, it did not significantly impact the internal mechanism or overall function.
Area of Science:
- Spinal Surgery
- Biomedical Engineering
- Implant Retrieval Analysis
Background:
- The MAGEC X magnetically controlled growing rod (MCGR) was recalled due to end-cap separation risks.
- Supply of MAGEC rods is currently suspended in the UK and EU, necessitating performance evaluation.
Purpose of the Study:
- To compare the retrieval performance of MAGEC X MCGRs against the earlier MAGEC 1.3 design.
- To assess the impact of the end-cap component issue on device functionality.
Main Methods:
- A multicentre comparative analysis of fifteen explanted MAGEC X and fifteen MAGEC 1.3 rods.
- Evaluations included visual inspection, radiography, force testing, and end-cap torque analysis.
- Statistical comparison using Mann-Whitney U tests.
Main Results:
- MAGEC 1.3 achieved significantly higher in vivo rod distraction.
- No significant differences were found in external damage, maximum force, or force test distraction.
- MAGEC X showed mildly higher elongation of stroke and one instance of end-cap loosening without major internal consequences.
Conclusions:
- MAGEC X demonstrates comparable retrieval performance to MAGEC 1.3.
- Observed end-cap loosening in MAGEC X did not lead to significant functional impairment.
- Further monitoring of the MAGEC X end-cap is warranted.
