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CoNNECT: A study of sutureless nerve repair

Conduit Nerve approximation versus Neurorraphy Evaluation of Clinical outcomes Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97234566
Enrollment
300
Registered
2019-02-04
Start date
2017-07-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Acute digital nerve transection injury in the hand Surgery Acute digital nerve transection injury in the hand

Interventions

The study will enrol participants with traumatic injuries to the digital or common digital nerves within the hand and randomisation in a 1:1:1 ratio for each nerve injury. They will be stratified acco

Sponsors

University Hospitals Birmingham NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pre-operative inclusion criteria: 1. Age between 16-75 years 2. Traumatic lesion less than 10 days old 3. Clinical suspicion of a complete traumatic nerve lesion to a sensory nerve between the distal flexor retinaculum and the midpoint of the middle phalanx 4. Ability to consent to the trial and comply with the follow up regime. Intra-operative inclusion criteria: 1. Verification of a complete traumatic lesion of a sensory nerve 2. Nerve amenable to suture directly without excessive flexion of digit (MCPJ and PIPJ positioning less than 30 degrees of flexion)

Exclusion criteria

Exclusion criteria: Pre-operative exclusion criteria: 1. Wound infection 2. Traumatic amputation 3. Previous history of injury to the nerves in the injured digit 4. Patients diagnosed with peripheral neuropathy 5. Participation in other trials Intra-operative exclusion criteria: 1. Nerve gap due to segmental loss requiring a graft or conduit 2. Double level injury to the same nerve 3. Severe contamination necessitating a further surgical procedure prior to closure

Design outcomes

Primary

MeasureTime frame
Sensory recovery using static and moving two-point discrimination (tactile gnosis) for each repaired nerve. The comparable area on the opposite hand will be tested for static and moving two-point discrimination to act as a baseline for assessment of recovery. These measurements will allow the modified Weber score to be calculated. This will be assessed at weeks 2, 6, 12, 26 and 52.

Secondary

MeasureTime frame
The following will be assessed at weeks 2, 6, 12, 26 and 52: 1. Monofilament pressure thresholds (innervation density), assessed using the WEST Monofilaments 2. Upper extremity disability and symptoms, assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) score 3. Self-rated health, assessed using the EQ-5D 4. Nerve irritation, assessed using differential Tinel's sign 5. Pain, assessed using a visual analogue scale (VAS) 6. Cold intolerance, assessed using a VAS 7. Hyperaesthesia, assessed using a VAS 8. Site of repair, measured in mm from the hyponychium of the same digit (the duration of each repair will be recorded) 9. For suture repairs, the quality of the repair will be recorded using the visual grading scale for suture-only nerve repair 10. For common digital nerve repair, the outcome for each digital nerve territory will be recorded

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026