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临床试验/NCT05242302
NCT05242302已完成1 期

Efficacy of End-to-Side Nerve Transfer for Patients With Severe Cubital Tunnel Syndrome

University of Alberta2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
65
试验地点
2
主要终点
Motor nerve conduction study

研究概览

简要总结

Ulnar nerve compressive injury due to cubital tunnel syndrome is very common. Because of the long distance to the target muscles in the hand, functional outcome in severe cases even with decompression surgery is often poor. Therefore, alternative treatment options are much needed. Recently, anterior interosseous nerve reverse end to side (RETS) transfer to the ulnar nerve above the wrist has gained popularity. However, whether a substantial portion of motor axons in the donor nerve are indeed capable of breaching the connective tissues in the ulnar nerve to reach the target muscles in the hand remains untested. To answer this crucial question, in this study the investigators plan to recruit 60 cubital tunnel syndrome patients with marked motor axonal loss who will undergo the RETS procedure. Motor unit number estimation will be done on the ulnar and anterior interosseous nerves at baseline and repeated at 3 and 6 months post operatively. Hand motor function and disability scores will also be tested at the same time points. Given the importance of this critical question and the potential utilities of distal nerve transfers, this should be a worthwhile effort.

详细描述

Introduction Peripheral nerve trauma especially through compressive injury is very common. Of these, ulnar neuropathy at the elbow is the second most prevalent. In severe cases, functional outcomes even with surgery are often poor. Principle reasons being that the ulnar nerve innervates a large number of intrinsic hand muscles. At an average of 350 mm from the site of injury to the target muscles, the distance is very long, Although peripheral nerve fibres have the ability to regenerate, it is very slow at only 1 mm/day. That would translate to a year for the regenerating fibres to reach the hand. With the favorable condition in the distal stump and target muscles to regrowth rapidly declining over time, few axons will successfully reach target. Therefore, alternative methods of surgical treatments are being sought to circumvent this major hurdle.

Rationale and purpose One potentially promising alternative is through distal nerve transfer by using a terminal branch of the anterior interosseous nerve (AIN) to the pronator quadratus muscle and coapt it to the ulnar nerve close to the wrist. That would greatly shorten the distance to target by 200 mm or more. By approximating the end of the AIN donor stump to the side of the ulnar nerve through an eipneurial window (termed reverse end to side or RETS) transfer, it allows preservation of the integrity of the ulnar nerve fibres thus providing a conduit for the regenerating native axons to reach the hand. While this concept is theoretically appealing and has gained increasing popularity in clinical practice, a crucial question of central importance remains answered: Can the AIN donor axons indeed breach the ulnar nerve trunk and reinnervate the hand muscles? Aside from testing the central premise of RETS, it would be important to know the exact magnitude of reinnervation that can be achieved from the donor nerve through this procedure.

With the above rationale in mind, the objective of this proposal is to test the hypothesis that reinnervation of ulnar intrinsic hand muscles by the AIN can be achieved through the RETS procedure. This will be done through quantifying the amount of innervation by the AIN donor nerve to the ulnar intrinsic hand muscles using motor unit number estimation, a non-invasive electrophysiological technique. The investigators will also evaluate whether there is an associated improvement in hand function following the procedure.

Experimental protocol Subjects For this study, the investigators aim to recruit a prospective series of 60 patients with severe cubital tunnel syndrome causing marked motor axonal loss.

Primary outcome measures Motor unit number estimations of native axons in the ulnar nerve innervation the intrinsic hand muscles compared to those from the AIN.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age > 18)
  • Symptoms and signs indicative of cubital tunnel syndrome
  • Markedly depleted motor unit number estimate in the ulnar intrinsic hand muscles > 2 SD below the mean

排除标准

  • Other co-existing neurological or musculoskeletal conditions affecting hand function
  • Cognitive impairments rendering patient unable to follow instructions to perform functional tasks
  • Unwilling to consent to the study

结局指标

主要结局

Motor nerve conduction study

时间窗: patients will be followed for 6 months after surgery

Amplitudes of the maximum compound muscle action potentials evoked by median nerve stimulation

次要结局

  • Key pinch strength(patients will be followed for 6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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