Randomisation to end to side anterior interosseous nerve transfer in cubital tunnel syndrome

A randomised controlled trial of end-to-side anterior interosseous nerve transfer augmentation of ulnar nerve function in moderate and severe cubital tunnel syndrome

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18379703

Enrollment

Registered

2024-05-14

Start date

2024-05-01

Completion date

Unknown

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve transfer to patients having surgery for cubital tunnel syndrome Musculoskeletal Diseases

Interventions

The primary objective of the REACTs study is to understand the willingness of participants to participate in a randomised intervention for end-to-side nerve transfer following ulnar nerve decompressio

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged ? 18 years old 2. CuTS diagnosed on clinical examination 3. Neurophysiology grade Moderate or Severe (as per the Padua classification) 4. Intrinsic muscle paralysis OR 5. Intrinsic muscle weakness/wasting 6. EMG confirmation of UN innervated intrinsic hand muscle denervation (partial/complete) 7. Willingness to be randomised 8. Able to complete the follow-up pathway

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent due to fluctuating or non-transient impairment of the mind 2. Patients in police custody 3. Known peripheral neuropathy 4. Current pregnancy 5. Patients with a history of other neuropathy which could affect the AIN function 6. Patients without a functioning Pronator Teres muscle

Design outcomes

Primary

Measure	Time frame
Functional recovery measured using the Patient-Reported Ulnar Nerve Evaluation (PRUNE) score at 12 months	—

Secondary

Measure	Time frame
The following secondary outcome measures will be assessed at baseline, 3 months and 12 months: 1. Sensory assessment measured using Semmes-Weinstein Monofilaments threshold testing 2. Motor Assessment measured using the Medical Research Council grading for motor function of target muscles, alongside: 2.1. Key Pinch testing in kilograms 2.2. Tripod Pinch testing in kilograms 2.3. Grip strength testing using the Jamar Level II 3. Patient-reported quality of life measured using: 3.1. Patient-Reported Ulnar Nerve Evaluation (PRUNE) score 3.2. Euroqol EQ5D-5L for quality of life assessment 3.3. Numerical Rating Scale (NRS) for pain 4. Complication rates measured using: 4.1. Wilson-Krout Criteria Outcome Measures 4.2. Presence of Complications At 6 months: Patient-reported outcome measures will be collected only	—

Measure

Time frame

The following secondary outcome measures will be assessed at baseline, 3 months and 12 months: 1. Sensory assessment measured using Semmes-Weinstein Monofilaments threshold testing 2. Motor Assessment measured using the Medical Research Council grading for motor function of target muscles, alongside: 2.1. Key Pinch testing in kilograms 2.2. Tripod Pinch testing in kilograms 2.3. Grip strength testing using the Jamar Level II 3. Patient-reported quality of life measured using: 3.1. Patient-Reported Ulnar Nerve Evaluation (PRUNE) score 3.2. Euroqol EQ5D-5L for quality of life assessment 3.3. Numerical Rating Scale (NRS) for pain 4. Complication rates measured using: 4.1. Wilson-Krout Criteria Outcome Measures 4.2. Presence of Complications At 6 months: Patient-reported outcome measures will be collected only

—

Countries

United Kingdom

Contacts

Public ContactChristopher McGhee

christopher.mcghee@uhb.nhs.uk+44 (0)121 371 8102

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026