About this trial
Last updated 2 years ago
Study ID
Pro00066610
Status
Completed
Type
Interventional
Phase
Phase 1/Phase 2
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- 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
Exclusion Criteria
- 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