Abstract

Lumbar disc herniation is one of the most common degenerative spinal conditions resulting in lower back pain and sciatica. Surgical treatment options include microdiscectomy, lumbar fusion, total disc replacement, and other minimally invasive approaches. At present, microdiscectomy procedures are the most used technique; however, the annulus fibrosus is left with a defect that without treatment may contribute to high reherniation rates and changes in the biomechanics of the lumbar spine. This paper aims to review current commercially available products that mechanically close the annulus including the AnchorKnot® suture-passing device and the Barricaid® annular closure device. Previous studies and reviews have focused mainly on a biomimetic biomaterials approach and have described some mechanical and biological requirements for an active annular repair/regeneration strategy but are still far away from clinical implementation. Therefore, in this paper we aim to create a design specification for a mechanical annular closure strategy by identifying the most important mechanical and biological design parameters, including consideration of material selection, preclinical testing requirements, and requirements for clinical implementation.

Highlights

  • Degenerative changes in the intervertebral discs (IVDs) can cause a loss of hydration in the nucleus pulposus reducing IVD height. This leads to a greater load transfer to the surrounding annulus fibrosus (AF) creating microstructural damage in the fibers that with time can develop into bigger tears [7,8]

  • If any annular healing occurs after discectomy, it is believed to happen thatslowly patients with large annular defects (≥6 mm) after lumbar discectomy have higher risk and results in biomechanically inferior tissue with reduced capacity for symptom recurrence to those with small annular to accommodate tensile and forcesreoperation

  • If any annular healing occurs after discectomy, it is believed to tissue engineering is investigating biomimetic approaches to replicate the lamellar structure slowly and results in biomechanically inferior tissue with reduced capacity to and induce regeneration [28]; the avascular nature of this region and the low accommodate tensile forces [19]

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Summary

Background

Low back pain is among the leading causes of disability in the world [1]. Injury or degeneration of intervertebral discs (IVDs) in the spine can be a cause of this disability. The IVD consists of a central nucleus pulposus, an irregular meshwork of collagen II fibrils with an osmotic swelling pressure created by large amounts of proteoglycan aggrecan aggregated along chains of hyaluronan This is surrounded by the annulus fibrosis, collagen I fibers oriented in oblique angles in a heterogeneous structure in distinct lamellae, with the collagen fibers laid up in alternating oblique angles in each consecutive lamella to form an angle-ply architecture [2,3,4,5,6]. Degenerative changes in the intervertebral discs (IVDs) can cause a loss of hydration in the nucleus pulposus reducing IVD height. This leads to a greater load transfer to the surrounding annulus fibrosus (AF) creating microstructural damage in the fibers that with time can develop into bigger tears [7,8].

Intervertebraldisc disc structure
Inclose and Xclose Systems
Design Requirements for an Annular Closure Device
Aims and Scope
Mechanical Requirements
Biological Requirements
Material Requirements
Preclinical Testing
Sterilization
Delivery and Attachment
Postoperative Imaging
Same Level Symptomatic Reherniation
Pain Score Improvement
Current Testing Standards
Test Methods For Spinal
Findings
Conclusions and Recommendations
Full Text
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