背景:目前无法无张力间隙闭合的周围神经损伤的修复选择包括同种异体移植,经处理的同种异体神经移植,和中空管导管。在这里,我们报告了多中心前瞻性的结果,随机化,患者-和评估者-致盲,比较处理后的同种异体神经移植和空心导管在手中的数字神经重建的初步研究。
方法:在4个中心,同意符合纳入标准但不符合排除标准的参与者在术中被随机分配至经过处理的同种异体神经移植物或中空导管.在基线时进行标准感官和安全性评估,重建后1、3、6、9和12个月。主要结果是静态2点辨别(s2PD)测试。参与者和评估者对治疗视而不见。对侧手指作为对照。
结果:我们随机分配了23名31指状神经损伤的参与者。16名进行20次维修的参与者进行了至少6个月的随访,而15次维修可进行12个月的随访。治疗组之间的参与者和基线特征没有显着差异。主要的神经损伤是裂伤/尖锐横切。两组修复前神经间隙的平均±SD长度为12±4mm(5-20mm)。经处理的同种异体移植物的平均s2PD为5±1mm(n=6),而中空导管的s2PD为8±5mm(n=9)。经处理的同种异体移植物的平均移动2PD为5±1mm,而中空导管为7±5mm。与导管组修复的75%相比,随机分配到处理过的同种异体神经移植物的所有损伤均恢复了一定程度的s2PD。在研究期间由于感染而丢失了两个中空导管和一个同种异体移植物。
结论:在这项初步研究中,与空心导管相比,采用经处理的同种异体神经移植物进行指神经重建的患者的功能感觉结果显著改善,且更加一致.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.