Journal article
Development of a clinically relevant impingement test method for a mobile bearing lumbar total disc replacement
The spine journal, v 16(9), pp 1133-1142
Sep 2016
PMID: 27179625
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Total disc arthroplasty is an alternative therapy to spinal fusion for the treatment of neck or low back pain and is hypothesized to reduce the risk of disease progression to the adjacent spinal levels. Radiographic and retrieval analyses of various total disc replacements (TDRs) have shown evidence of impingement damage. Impingement of TDRs can occur when the device reaches the limits of its functional range of motion, causing contact between peripheral regions of the device.
Impingement can be associated with increased wear and mechanical damage; however, impingement conditions are not simulated in current standardized mechanical bench test methods. This study explored the test conditions necessary to apply clinically relevant impingement loading to a lumbar TDR in vitro.
An experimental protocol was developed and evaluated using in vivo retrievals for qualitative and quantitative validation.
Retrieval analysis was conducted on a set of 11 size 3 retrieved Charité devices using American Society for Testing and Materials F561 as a guide. The impingement range of motion was determined using a combination of modeling and experiments, and was used as an input in vitro testing. A 1-million cycle in vitro test was then conducted, and the in vitro samples were characterized using methods similar to the retreived devices.
All in vitro tested samples exhibited impingement regions and damage patterns consistent with retrieved devices. Consistent with the retrievals, the impingement damage on the rim was a combination of abrasive wear and plastic deformation. Micro computed tomography (microCT) was used to quantitatively assess rim damage due to impingement. Rim penetration was statistically lower in the retrievals when compared with both in vitro groups. Rim elongation was comparable among all groups. The simulated-facet group had statistically greater angular rim deformations than the retrieval group and the no-facet group.
Results demonstrate that clinically relevant impingement seen on mobile bearings of lumbar TDRs can be replicated on the bench.
Metrics
Details
- Title
- Development of a clinically relevant impingement test method for a mobile bearing lumbar total disc replacement
- Creators
- Ryan Siskey - Drexel UniversityJonathan Peck - United States Food and Drug AdministrationHitesh Mehta - United States Food and Drug AdministrationAllison Kosydar - Drexel UniversitySteven Kurtz - Exponent (United States)Genevieve Hill - United States Food and Drug Administration
- Publication Details
- The spine journal, v 16(9), pp 1133-1142
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- School of Biomedical Engineering, Science, and Health Systems
- Web of Science ID
- WOS:000386368700047
- Scopus ID
- 2-s2.0-84991490842
- Other Identifier
- 991019167331204721
UN Sustainable Development Goals (SDGs)
This publication has contributed to the advancement of the following goals:
InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Clinical Neurology
- Orthopedics