204. A clinical pilot study showing the safety and efficacy of intramuscular injection of atelocollagen for prevention of paraspinal muscle atrophy after spine surgery

Abstract

<h3>BACKGROUND CONTEXT</h3> Atelocollagen has been widely used as an intradermal filler to restore soft tissue defects. Many studies demonstrated that atelocollagen provides good therapeutic results by promoting cell proliferation and enhances the healing effect on injured muscles and connective tissues such as tendons and fasciae while causing few complications. <h3>PURPOSE</h3> This clinical study was designed to assess the safety and efficacy of intramuscular injection of atelocollagen for the prevention of paraspinal muscle atrophy after spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective observational study. <h3>PATIENT SAMPLE</h3> A total of 118 patients who underwent single- or two-level posterior lumbar interbody fusion (PILF) between December 2017 and April 2019 were retrospectively reviewed. <h3>OUTCOME MEASURES</h3> Clinical efficacy was evaluated by the improvement of back pain, elevation of a muscle enzyme, and inflammatory markers. Radiologic efficacy was evaluated with a comparison of density and cross-sectional area (CSA) of multifidus and erector spinae muscle in CT images. The safety was assessed with vital sign monitoring and a survey on all adverse events over 12 weeks. <h3>METHODS</h3> In the study group of 30 patients, 3mL of gel-type 3% atelocollagen solution was prepared and injected into the multifidus muscle during wound closure. <h3>RESULTS</h3> Significant improvement of back pain was observed in all patients after the surgery. VAS for back pain was not significantly lower in the study group postoperatively compared with the control group. The reduction of postoperative paraspinal muscle density and CSA was significantly lower in the study group. The serum level of muscle enzyme and inflammatory markers were significantly lower in the study group. No major procedure-related complications were observed during the follow-up period. <h3>CONCLUSIONS</h3> Intramuscular injection of atelocollagen is safe and feasible for the prevention of paraspinal muscle atrophy after spine surgery. This novel method seems advantageous for accelerating wound healing without causing inflammation. Randomized controlled trials with larger data samples are needed to confirm the results. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.