Dataset Information

A Multicenter, Prospective, Randomized, Pilot Study of Outcomes for Digital Nerve Repair in the Hand Using Hollow Conduit Compared With Processed Allograft Nerve.

ABSTRACT: Current repair options for peripheral nerve injuries where tension-free gap closure is not possible include allograft, processed nerve allograft, and hollow tube conduit. Here we report on the outcomes from a multicenter prospective, randomized, patient- and evaluator-blinded, pilot study comparing processed nerve allograft and hollow conduit for digital nerve reconstructions in the hand.Across 4 centers, consented participants meeting inclusion criteria while not meeting exclusion criteria were randomized intraoperatively to either processed nerve allograft or hollow conduit. Standard sensory and safety assessments were conducted at baseline, 1, 3, 6, 9, and 12 months after reconstruction. The primary outcome was static 2-point discrimination (s2PD) testing. Participants and assessors were blinded to treatment. The contralateral digit served as the control.We randomized 23 participants with 31 digital nerve injuries. Sixteen participants with 20 repairs had at least 6 months of follow-up while 12-month follow-up was available for 15 repairs. There were no significant differences in participant and baseline characteristics between treatment groups. The predominant nerve injury was laceration/sharp transection. The mean ± SD length of the nerve gap prior to repair was 12 ± 4 mm (5-20 mm) for both groups. The average s2PD for processed allograft was 5 ± 1 mm (n = 6) compared with 8 ± 5 mm (n = 9) for hollow conduits. The average moving 2PD for processed allograft was 5 ± 1 mm compared with 7 ± 5 mm for hollow conduits. All injuries randomized to processed nerve allograft returned some degree of s2PD as compared with 75% of the repairs in the conduit group. Two hollow conduits and one allograft were lost due to infection during the study.In this pilot study, patients whose digital nerve reconstructions were performed with processed nerve allografts had significantly improved and more consistent functional sensory outcomes compared with hollow conduits.

SUBMITTER: Means KR

PROVIDER: S-EPMC4920529 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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A Multicenter, Prospective, Randomized, Pilot Study of Outcomes for Digital Nerve Repair in the Hand Using Hollow Conduit Compared With Processed Allograft Nerve.

Means Kenneth R KR Rinker Brian D BD Higgins James P JP Payne S Houston SH Merrell Gregory A GA Wilgis E F Shaw EF

Hand (New York, N.Y.) 20160217 2

<h4>Background</h4>Current repair options for peripheral nerve injuries where tension-free gap closure is not possible include allograft, processed nerve allograft, and hollow tube conduit. Here we report on the outcomes from a multicenter prospective, randomized, patient- and evaluator-blinded, pilot study comparing processed nerve allograft and hollow conduit for digital nerve reconstructions in the hand.<h4>Methods</h4>Across 4 centers, consented participants meeting inclusion criteria while ...[more]

PMID: 27390554

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Project description:Nerve conduits have become an established option for repair of sensory deficits of up to 2 cm. More recently, decellularized nerve allograft has also been advocated as an option for nerve repair; however, no clinical studies have examined its efficacy for the treatment of sensory nerve defects. The aim of this study was to examine our early experience with the use of decellularized nerve allograft for repair of segmental nerve defects within the hand and fingers. From July 2007 to March 2008, seven patients who had ten nerve gaps were treated surgically using decellularized nerve allograft. Eight digital and two dorsal sensory nerves were repaired. The etiologies of the nerve defects were traumatic nerve transection in eight defects and neuroma resection and reconstruction in two defects. All of the affected nerves were pure sensory fibers. Functional recovery was evaluated by blinded hand therapist using moving and static two point discrimination tests. Implantation sites were also evaluated for any signs of infection, rejection, or graft extrusion. There were five men and two women with a mean age of 44 years (range 23-65). Mean nerve graft length was 2.23 cm with a range of 0.5-3 cm. Mean follow up time was 9 months (range 5-12). Average two point discrimination was 4.4 mm moving and 5.5 mm static at last recorded follow-up. There were no wound infections observed around the graft material and sensory improvement was observed in all of the patients despite this short-term follow-up. Re-exploration of two fingers was required for flexor tendon rupture in one and flexor tendon tenolysis in the other. In both cases, the nerve allograft was visualized and appeared well incorporated in the repair site. Decellularized nerve allografts were capable of returning adequate sensation in nerve defects ranging from 0.5 to 3 cm. There were no cases of infection or rejection. Decellularized nerve allograft may provide an option for segmental nerve gaps beyond 2 cm. Randomized comparative studies will be required to determine efficacy in comparison to collagen conduits or nerve autograft.

Project description:Peripheral nerve regeneration requires stepwise and well-organized establishment of microenvironment. Since local delivery of VEGF-A in peripheral nerve repair is expected to promote angiogenesis in the microenvironment and Schwann cells (SCs) play critical role in nerve repair, combination of VEGF and Schwann cells may lead to efficient peripheral nerve regeneration. VEGF-A overexpressing Schwann cells were established and loaded into the inner wall of hydroxyethyl cellulose/soy protein isolate/polyaniline sponge (HSPS) conduits. When HSPS is mechanically distorted, it still has high durability of strain strength, thus, can accommodate unexpected strain of nerve tissues in motion. A 10 mm nerve defect rat model was used to test the repair performance of the HSPS-SC (VEGF) conduits, meanwhile the HSPS, HSPS-SC, HSPS-VEGF conduits and autografts were worked as controls. The immunofluorescent co-staining of GFP/VEGF-A, Ki67 and MBP showed that the VEGF-A overexpressing Schwann cells could promote the proliferation, migration and differentiation of Schwann cells as the VEGF-A was secreted from the VEGF-A overexpressing Schwann cells. The nerve repair performance of the multifunctional and flexible conduits was examined though rat behavioristics, electrophysiology, nerve innervation to gastrocnemius muscle (GM), toluidine blue (TB) staining, transmission electron microscopy (TEM) and NF200/S100 double staining in the regenerated nerve. The results displayed that the effects on the repair of peripheral nerves in HSPS-SC (VEGF) group was the best among the conduits groups and closed to autografts. HSPS-SC (VEGF) group exhibited notably increased CD31+ endothelial cells and activation of VEGFR2/ERK signaling pathway in the regenerated nerve tissues, which probably contributed to the improved nerve regeneration. Altogether, the comprehensive strategy including VEGF overexpressing Schwann cells-mediated and HSPS conduit-guided peripheral nerve repair provides a new avenue for nerve tissue engineering.

Project description:Background: Peripheral nerve injuries are common, with approximately 9,000 cases in the UK annually. Young working individuals are predominantly affected, leading to significant health and social implications. Functional recovery is often poor with impaired hand sensation, reduced motor function and pain and cold intolerance. Where a nerve gap exists, nerve grafting remains the gold-standard treatment but creates a second surgical site, sensory deficit at the donor site, possible neuroma formation and has limited availability. Current commercially available synthetic and resorbable nerve conduit alternatives are reported to be rigid and inflexible. This study will set out to examine the first-in-man use of a new nerve conduit device 'Polynerve' to repair small nerve gaps in digital sensory nerves of the hand. Polynerve is a degradable co-polymer of poly-?-caprolactone and poly-l-lactic acid, which is shaped as a cylinder that has greater tensile strength, flexibility and less acidic degradation compared with current commercially available synthetic nerve conduits. In addition, it has a novel micro-grooved internal lumen that aids Schwann cell ingress and alignment to improve nerve regeneration. Methods: In total, 17 eligible participants will be recruited to undergo repair of a transected sensory nerve of the hand using the Polynerve device. All participants that receive the nerve conduit device will be followed for a period of 12 months post-surgery. The primary endpoint is safety of the device and the secondary endpoint is degree of sensory nerve regeneration through the conduit assessed using standard sensory testing (2-PD, WEST monofilament testing and locognosia). Discussion: The 'UMANC' trial is a single-centre UK-based, prospective, unblinded, phase I clinical trial of a novel nerve conduit device. We aim to demonstrate the safety of Polynerve as a synthetic, biodegradable nerve conduit and improve the treatment options available to patients with significant nerve injuries. Registration: Clinicaltrials.gov: NCT02970864; EudraCT: 2016-001667-37.

Dataset Information

A Multicenter, Prospective, Randomized, Pilot Study of Outcomes for Digital Nerve Repair in the Hand Using Hollow Conduit Compared With Processed Allograft Nerve.

Publications

A Multicenter, Prospective, Randomized, Pilot Study of Outcomes for Digital Nerve Repair in the Hand Using Hollow Conduit Compared With Processed Allograft Nerve.

Similar Datasets

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