Introduction: A variety of biodegradable implants (screws, rods, plates and cages) are available which are composed of many different biodegradable polymers with varying characteristics. The present review of animal and clinical studies examines the efficacy and safety of biodegradable implants in spinal fracture intervention.
Methods: A review of the literature through March 2018 was performed using PubMed and Cochrane databases. Success rates were calculated according to sufficient tissue biocompatibility, solid clinical fusion and propensity for osseointegration.
Results: 49 articles (24 animal and 25 human studies) were included. In animal experiments, the overall success rate for spinal fusion was 60.3%, while the mean success rate regarding the cervical spine was 51.8% compared to 68.1% for the lumbar spine (p = 0.002). In studies involving control group(s): the mean bioabsorbable implant success rate for spinal fusion was 42% compared to 57% for conventional implants (p = 0.0016). In the lumbar spine pL-lactide acid (PLLA) had 75.2% success rate compared to poly (L-lactide-co-DL-lactide) (PLDLLA) at 53.4% (p = 0.003). In clinical studies, the overall mean success rate was 89%, while the mean success rate regarding the cervical spine was 92%, as compared to 83.6% for the lumbar spine (p = 0.001). In studies involving control group(s): the mean bioabsorbable implant success rate was 75% compared to a conventional implant mean success rate of 97% (p<0.0001). In the cervical spine PLLA had a 98.7% success rate compared to 90% with PLDLLA (p = 0.015). In the lumbar spine PLDLLA had 84.7% success rate compared to 63.6% for poly-glycolic acid (PGA) (p = 0.085).
Discussion: Studies combined biodegradable and conventional implants. Polymers were used in various combinations and surface modification of the implants also varied. Comparison studies were of small sample size. Animal and clinical studies diverged. The current data are not encouraging. The end-point of assessing osseointegration varies in the studies and is indeterminate. In early stages the structure comparison of osseous restoration using biodegradable implants appears inferior to utilization of conventional cages and instrumentation. There is no statistically significant evidence supporting the efficacy of biodegradable implants replacing traditional instrumentation. There is a lack of prospective clinical trials with long-term follow-up regarding utilization of biodegradable implants and the available data does not support their routine use in spinal fracture intervention.
Keywords: Bioabsorbable; Fusion; Implants; Spinal fixation; Spine.
Copyright © 2018. Published by Elsevier Ltd.