A New Standardized Clinical Model for Evaluation of Nerve Guides: A Single-Blinded Randomized Controlled Prospective Study.
BACKGROUND: Autologous nerve transplantation is the accepted clinical standard for reconstruction of peripheral nerve defects. Bioengineered nerve guides as an alternative to autologous nerve transplantation have been described in previous studies and several different types are commercially available. Examination of the implementation of these devices in the clinical setting is an important step in determining their applicability in reconstructive nerve surgery.
METHODS: In a single-blinded randomized controlled prospective study, the authors examined 34 patients undergoing diagnostic nerve biopsy (2 cm). The biopsy-induced nerve gap was interposed using a segment of the lesser saphenous vein in 16 patients. Eighteen patients had no nerve reconstruction and served as a control group. A further 10 participants were included as a healthy cohort. Nerve regeneration was assessed using von Frey filaments preoperatively and 1 day and 3, 6, 9, and 12 months postoperatively.
RESULTS: Patients who received defect bridging of the sural nerve with a venous graft showed better regeneration of lateral foot sensitivity than patients without venous graft.
CONCLUSIONS: The distal sural nerve biopsy can be used as a baseline model to evaluate peripheral nerve regeneration. Newly developed nerve guides could be tested in other unpredictable and challenging clinical peripheral nerve lesions.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.