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Bionate Lumbar Disc Nucleus Prosthesis: Biomechanical Studies in Cadaveric Human Spines
Amparo Vanaclocha1, Vicente Vanaclocha2, Carlos M Atienza1
1Biomechanical Engineer, Biomechanics Institute of Valencia, Valencia 46022, Spain.
ACS Omega
|December 26, 2022
Summary
Spine nucleus replacement moderately increased disc mobility in cadaveric spines, with implants showing low expulsion and subsidence risks despite some operative damage. Customized implants are recommended.
Area of Science:
- Spine Biomechanics
- Orthopedic Surgery
- Biomaterials Science
Background:
- Degenerative disc disease is a common cause of low back pain.
- Nucleus replacement aims to restore spinal biomechanics and alleviate pain.
- Understanding the biomechanical performance of nucleus replacement devices is crucial.
Purpose of the Study:
- To determine the biomechanical performance of the Bionate 80A nucleus replacement device in cadaveric spines.
- To compare the biomechanics of customized versus overdimensioned implants.
- To assess the effects of nucleus replacement on spinal mobility and implant stability.
Main Methods:
- Cadaveric spines (L3-L4, L4-L5, L5-S1) underwent nucleotomy and nucleus implantation with either customized or overdimensioned Bionate 80A devices.
- Spinal motion (flexion, extension, lateral bending, torsion) was measured under increasing loads (2-8 Nm) using stereophotogrammetry.
- Expulsion tests (cyclic compression 50-550 N for 50,000 cycles) and subsidence tests (up to 6000 N compression) were performed.
Main Results:
- Nucleotomy increased disc mobility, particularly in lateral bending and torsion, with varying effects on adjacent segments.
- Nucleus implantation reduced mobility compared to nucleotomy but did not restore intact levels; overdimensioned implants showed similar or greater mobility than customized ones.
- No implant extrusion occurred up to 1068 N; anatomical structures collapsed first. No subsidence or fractures were observed up to 6812.3 N.
Conclusions:
- Nucleus implantation in nucleotomized cadaveric spines resulted in moderate mobility increases compared to intact spines, partly due to surgical damage.
- The Bionate 80A implant demonstrated low risks of expulsion and subsidence.
- Customized implants may offer better biomechanical profiles than overdimensioned ones.
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