DYNACORD™ Suture: A Summary of the in vivo Preclinical Evidence

David Spenciner, Mackenzie Mallard, Dennis Connelly, Vivian Liang

Keywords: DYNACORD™ Suture, laxity, in vivo, suture, rotator cuff

Introduction

Successful repair of soft tissue using sutures is critically dependent on reliable re-approximation of the soft tissue throughout the healing period. Potential reasons for clinical failure include excess laxity, suture cheesewire through tissue, and ischemia from overly tight repairs. DYNACORD™ Suture is a high-strength suture containing an outer braided sheath of UHMWPE surrounding an inner braided polyester sheath and a medical-grade silicone/sodium chloride-filled central core. It was designed to react and adjust to the stress of the local environment while maintaining an appropriate level of tension across the repair. The goal of this study was to review the existing in vivo data to determine if in these models, DYNACORD™ Suture addresses reasons for clinical failures.

Methods

Multiple GLP preclinical studies have been performed to assess the safety and efficacy of DYNACORD™ Suture in animal models. More specifically, an ovine shoulder model evaluated infraspinatus tendon gap closure, debris generation, and healing for both DYNACORD™ Suture and a competitive high-strength suture. A similar study of the ovine shoulder investigated the biological aspects of tendon healing for DYNACORD™ Suture and a competitive high-strength suture. Finally, a porcine knee model was used to investigate if suture debris could cause inflammation of the joint or migrate into the draining lymphatic system.

Results

Most importantly, the safety and efficacy of DYNACORD™ Suture was established for these animal models. Neither high-strength suture showed evidence of tissue necrosis, systematic toxicity, or suture degradation at 6 weeks post-repair in the ovine model [1]. Moreover, the remaining gap for the cut tendon was 50%-52% as much with DYNACORD™ Suture compared with the competitive suture [1]. Furthermore, no statistically significant differences in repair construct strength were found between the two sutures. Histological assessment of necrosis, cheesewiring, and regeneration showed less tissue damage from repairs with DYNACORD™ Suture [2]. Importantly, no debris from DYNACORD™ Suture was found to inflame the joint tissues or migrate to the lymphatic system [3].

Conclusion

The safety and efficacy of DYNACORD™ Suture have been demonstrated for these animal models. In these in vivo models, DYNACORD™ Suture exhibited an improved ability to maintain soft tissue approximation and decreased tissue necrosis and cheesewiring.

References

1. Favorito, P. J., Spenciner, D. B., Muench, T. R., Bartrom, J., & Ryu, R. K. (2019). Safety evaluation of A laxity-minimizing suture at 5 days and 6 weeks after repair of a Sheep INFRASPINATUS TENDON. Journal of Shoulder and Elbow Surgery, 28(1), 164-169. doi:10.1016/j.jse.2018.05.043

2. Darwiche, S. (2020). Evaluating the efficacy of DYNACORD™ suture – Histological evaluation of treated tendons.

3. Barber, F. A., Spenciner, D. B., Zani, B. G., & Melidone, R. (2019). Suture-based debris behavior in the draining lymph nodes of a porcine knee: A study of silicone, polyethylene and carbon. Arthroscopy, Sports Medicine, and Rehabilitation, 1(2). doi:10.1016/j.asmr.2019.09.006

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