Abstract
Purpose
Nucleus pulposus (NP) replacements represent a less invasive alternative for treatment of early stage degenerative disc disease (DDD). Hydrogel based NP replacements are of particular interest as they can be injected/implanted using minimally invasive surgical (MIS) techniques to re-establish mechanical integrity and as a scaffold for regeneration. A thiol-modified hyaluronan elastin-like polypeptide (TMHA/EP) hydrogel crosslinked using polyethylene diacrylate has shown promise as a potential NP replacement for DDD in vitro. This study aims to assess the mechanical properties of this hydrogel when injected into an induced early stage DDD porcine model and to determine the optimal injection method for delivery. It is hypothesized that minimally invasive injection of the TMHA/EP material can restore mechanical behaviour of spinal motion segments in early stage DDD.
Method
Intervertebral disc (IVD) degeneration was enzymatically induced in L2-L3 and L4-L5 lumbar levels in 10 Yorkshire boars using chondroitinase ABC (n=20 discs). An additional three animals served as healthy controls (n=6 discs). Following a four-week degradation period, the TMHA/EP solution (250microL in a 3:1 weight ratio) was injected into the degenerate NP of 16 discs by one of two MIS techniques: A direct 18G needle injection or a modified kyphoplasty technique (MKT) in which a balloon angiocatheter was inserted through an 11G trocar into the IVD and inflated to create a cavitary defect that was then filled with the hydrogel. Excised motion segments were tested in axial compression under a load of 400N and in axial rotation (AR), lateral bending (LB) and flexion/extension (FE) at 5Nm. Range of motion (ROM), neutral zone (NZ) length, NZ stiffness (NZStiff) and axial compressive stiffness (ACStiff) were quantified.
Results
The degenerate control motion segments were, in general, found to be significantly less stiff and more flexible than the healthy controls. In comparison to the degenerate controls, direct injection of TMHA/EP demonstrated increased ACStiff and AR NZStiff (23%, 77%; p<0.05) and the MKT yielded a significant increase in AR NZStiff (88%) with a trend towards increased FE NZStiff (253%, p=0.089). Following TMHA/EP augmentation, direct injection and MKT treated IVDs demonstrated similar stiffness to healthy intact controls (p=0.519–1.000). Both ROM and NZ length in AR significantly increased following degeneration of the IVDs as compared to healthy controls (49%, 63%) In comparison to degenerate controls, both MIS techniques showed similar significant decreases in AR ROM (32%, 33%) and AR NZ length (35%, 32%). Both injection methods worked to restore motion to levels similar to healthy controls (p=0.173–1.00). Differences were not detected between the two treatment groups for all outcome variables (p=0.115–0.916).
Conclusion
This study demonstrated the ability of the TMHA/EP composite to restore initial biomechanical function in early stage DDD independent of the MIS technique.
