Cubital Tunnel Syndrome Clinical Trial
Official title:
Randomized Controlled Trial of Supercharged End-to-Side (SETS) Anterior Interosseous Nerve Transfer for Severe Cubital Tunnel Syndrome
Verified date | January 2022 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Functional motor recovery distal to a peripheral nerve lesion is predicated upon time to reinnervation of the motor end plate and the number of regenerate axons that reach the target. Supercharged end-to-side (SETS) transfer of the anterior interosseous nerve to the motor fascicle of the ulnar nerve at the level of the distal forearm has been proposed as an adjunct procedure in severe cubital tunnel syndrome to augment motor recovery of the ulnar-innervated intrinsic muscles. Multiple Level IV Therapeutic studies and a systematic review of Level IV Therapeutic studies have reported favorable clinical and electrodiagnostic outcomes following SETS for cubital tunnel syndrome, with low rates of complications. However, in the absence of controls, it remains unclear what proportion of the observed intrinsic motor recovery is attributable to the SETS procedure. The objective of this randomized trial is to compare the results of ulnar nerve decompression with or without SETS for severe cubital tunnel syndrome.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 27, 2022 |
Est. primary completion date | January 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years of age or older - Severe cubital tunnel syndrome is defined in this study as McGowan classification stage IIB or III disease (sensory deficits, motor deficits, and the presence of intrinsic atrophy) - Indicated for surgical treatment of severe cubital tunnel syndrome at one of the two participating institutions - Preoperative nerve conduction study and electromyography documenting ulnar neuropathy at the elbow with present fibrillations and positive sharp waves in the FDI or ADM within one year of surgery Exclusion Criteria: - Ulnar nerve transections - Traumatic brachial plexus injuries - Brachial plexus neuritis (e.g. Parsonage-Turner) - Cervical radiculopathy - Primary motor neuropathy (e.g. Charcot-Marie-Tooth) - Prior cubital tunnel surgery - Oncologic etiologies of ulnar nerve compression - Patients who are not capable of decision-making or are unable to understand the study procedures - Non-English speaking patients are excluded since our secondary outcome variables may not have been translated and validated in other language(s). |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Arriyan S. Dowlatshahi, Brandon E. Earp, Carl M. Harper, Christian E. Sampson, George S. M. Dyer, Lydia A. Helliwell, Matthew J. Carty, Philip Blazar, Simon G. Talbot, Tamara D. Rozental |
United States,
Barbour J, Yee A, Kahn LC, Mackinnon SE. Supercharged end-to-side anterior interosseous to ulnar motor nerve transfer for intrinsic musculature reinnervation. J Hand Surg Am. 2012 Oct;37(10):2150-9. doi: 10.1016/j.jhsa.2012.07.022. — View Citation
Bertelli JA. Subterminal key pinch dynamometry: a new method to quantify strength deficit in ulnar nerve paralysis. J Hand Surg Eur Vol. 2020 Oct;45(8):813-817. doi: 10.1177/1753193420919283. Epub 2020 Apr 29. — View Citation
Davidge KM, Yee A, Moore AM, Mackinnon SE. The Supercharge End-to-Side Anterior Interosseous-to-Ulnar Motor Nerve Transfer for Restoring Intrinsic Function: Clinical Experience. Plast Reconstr Surg. 2015 Sep;136(3):344e-352e. doi: 10.1097/PRS.0000000000001514. — View Citation
Dengler J, Dolen U, Patterson JMM, Davidge KM, Kahn LC, Yee A, Mackinnon SE. Supercharge End-to-Side Anterior Interosseous-to-Ulnar Motor Nerve Transfer Restores Intrinsic Function in Cubital Tunnel Syndrome. Plast Reconstr Surg. 2020 Oct;146(4):808-818. doi: 10.1097/PRS.0000000000007167. — View Citation
Dunn JC, Gonzalez GA, Fernandez I, Orr JD, Polfer EM, Nesti LJ. Supercharge End-to-Side Nerve Transfer: Systematic Review. Hand (N Y). 2021 Mar;16(2):151-156. doi: 10.1177/1558944719836213. Epub 2019 Mar 29. — View Citation
Head LK, Zhang ZZ, Hicks K, Wolff G, Boyd KU. Evaluation of Intrinsic Hand Musculature Reinnervation following Supercharge End-to-Side Anterior Interosseous-to-Ulnar Motor Nerve Transfer. Plast Reconstr Surg. 2020 Jul;146(1):128-132. doi: 10.1097/PRS.0000000000006903. — View Citation
Jarvie G, Hupin-Debeurme M, Glaris Z, Daneshvar P. Supercharge End-to-Side Anterior Interosseous Nerve to Ulnar Motor Nerve Transfer for Severe Ulnar Neuropathy: Two Cases Suggesting Recovery Secondary to Nerve Transfer. J Orthop Case Rep. 2018 Sep-Oct;8(5):25-28. doi: 10.13107/jocr.2250-0685.1194. — View Citation
Koriem E, El-Mahy MM, Atiyya AN, Diab RA. Comparison Between Supercharged Ulnar Nerve Repair by Anterior Interosseous Nerve Transfer and Isolated Ulnar Nerve Repair in Proximal Ulnar Nerve Injuries. J Hand Surg Am. 2020 Feb;45(2):104-110. doi: 10.1016/j.jhsa.2019.11.005. Epub 2019 Dec 20. — View Citation
MacDermid JC, Grewal R. Development and validation of the patient-rated ulnar nerve evaluation. BMC Musculoskelet Disord. 2013 Apr 26;14:146. doi: 10.1186/1471-2474-14-146. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subterminal key pinch strength | The primary outcome variable of this study is subterminal key pinch strength assessed by dynanometer measured in kg. Subterminal key pinch strength is a direct assessment of ulnar-innervated muscle strength. | 18 months | |
Secondary | Patient-Rated Ulnar Nerve Evaluation (PRUNE) score | The PRUNE score is a validated patient-reported outcome measure of ulnar nerve function. The total PRUNE score ranges from 0 to 100, with 0 denoting no symptoms and 100 denoting the worst possible symptoms. | 18 months | |
Secondary | Disabilities of the Arm, Shoulder and Hand (DASH) score | The DASH score is a validated patient-reported outcome measure of upper extremity function. The total DASH score ranges from 0 to 100, with 0 denoting no disability and 100 denoting the most severe disability. | 18 months | |
Secondary | MRC forearm pronation strength | The MRC forearm pronation strength is a commonly used physician-rated scoring system for muscle strength on a 0 to 5 scale and will be used to assess donor deficits from an anterior interosseous nerve transfer, with 0 denoting no strength and 5 denoting full strength. | 18 months |
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