Microsurgical nerve repair in adult patients with recent traumatic digital nerve injury
| ISRCTN | ISRCTN16211574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16211574 |
| IRAS number | 258872 |
| Secondary identifying numbers | IRAS 258872 |
- Submission date
- 26/02/2020
- Registration date
- 28/02/2020
- Last edited
- 27/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Digital nerves are small nerves that pass along the side of each finger and provide sensation to the fingertips. These nerves can be accidentally cut when handling sharp objects like a knife or broken glass. The NEON study aims to find out whether sewing the ends of the cut nerve surgically is beneficial or even needed. Thoroughly cleaning the cut wound before closing the skin is a much simpler procedure, and may be satisfactory for patients.
There is some evidence that both treatments give good results. There is also some evidence that patients may not fully recover the feeling in their injured finger, even after sewing the nerve. Research so far has been conflicting and is of varying quality. For example, some studies do not directly compare treatments, or do not ask patients about their views of recovery.
The best way to find out if stitching the cut digital nerve is appropriate is to conduct a research study. NEON will compare surgical procedures for digital nerve injury, with or without stitches (also known as sutures). 478 patients will have one of these two treatment options by random allocation.
Who can participate?
Patients aged 18 years and above with a suspected complete digital nerve laceration in any single digit, including thumb and little finger, appropriate for surgical repair.
What does the study involve?
Patient questionnaires measuring fingertip sensation and quality of life will assess the benefit of each treatment up to 12 months after the operation. It will also be important to look into whether there is a difference in cost between the two treatments.
What are the possible benefits and risks of participating?
The researchers cannot guarantee a benefit to patients who take part in this study. The results from the study are likely to benefit future patients with nerve injuries.
Both procedures are already performed routinely in the NHS and there is no expected difference in risk between them, or to treatment outside of the study. Taking part in the study will not change the standard of care patients receive. If patients are concerned about the complications associated with this injury and surgery, the researchers advise they speak to their local care team
Where is the study run from?
University of Oxford Surgical Intervention Trials Unit (SITU) (UK)
When is the study starting and how long is it expected to run for?
April 2020 to December 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
SITU-NDORMS team
situ@ndorms.ox.ac.uk
Associate Prof. Jain (scientific)
situ@ndorms.ox.ac.uk
Contact information
Public
Surgical Intervention Trials Unit (SITU)
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 737929 |
|---|---|
| situ@ndorms.ox.ac.uk |
Scientific
Surgical Intervention Trials Unit (SITU)
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0002-1799-5310 |
|---|---|
| Phone | +44 (0)1865 737929 |
| situ@ndorms.ox.ac.uk |
Study information
| Study design | Multi-centre parallel double-blinded (patient and assessor) two-arm randomized controlled trial including economic analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not yet available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial assessing if microsurgical nerve repair offers clinical benefit and cost effectiveness (in terms of patient–reported hand function, sensory recovery and adverse events) over exploration and washout without microsurgical nerve repair in adult patients with recent traumatic digital nerve injury |
| Study acronym | NEON |
| Study hypothesis | The NEON study seeks to answer whether microsurgical digital nerve repair is clinically and cost effective. |
| Ethics approval(s) | Approved 10/02/2020 South Central - Oxford B Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048046; nrescommittee.southcentral-oxfordb@nhs.net), ref: 20/SC/0018 |
| Condition | Single unilateral digital nerve injury appropriate for surgical repair |
| Intervention | Patients are randomised in theatre after consent and after confirmation of eligibility through surgical exploration. A web-based randomisation system will be used and the allocations will be computer-generated with a 1:1 ratio, minimised by site, injury location and flexor tendon injury. The patient will receive one of the following treatments in theatre: 1 - Digital nerve surgery with microsurgical sutures 2 - Digital nerve surgery with realignment of nerve ends but no microsurgical sutures Patients will be followed up for 12 months by completing questionnaires and by attending clinical assessments. Patients will be followed up for a further 12 months using medical records and routine data. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical effectiveness of microsurgical nerve repair measured by the Impact of Hand Nerve Disorders (I-HaND) Patient Reported Outcome Measure at 12 months post-randomisation |
| Secondary outcome measures | 1. Neurosensory and functional recovery measured at 3 and 12 months post-randomisation by: 1.1. Hand Health Profile of the Patient Evaluation Measure 1.2. EQ-5D-5L index and –EQ-VAS 1.3. Static two-point discrimination test (2PD) 1.4. Tactile gnosis using Shape/Texture Identification (STI) test; and Touch thresholds using Weinstein Enhanced Sensory Test (WEST) monofilaments 2. Cost-effectiveness of microsurgical nerve repair, measured by Health resource use questionnaires and EQ-5D-5L index at 3 and 12 months post randomisation 3. Complications of surgery and clinically problematic neuroma rates measured at 3 and 12 months post-randomisation by: 3.1. Patient-reported complications 3.2. Clinical assessment (including Elliot score) 3.3. Complications and further procedures in medical records 3.4. Complications and further procedures based on medical records and routine data at 24 months post randomisation |
| Overall study start date | 01/10/2019 |
| Overall study end date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 478 |
| Total final enrolment | 122 |
| Participant inclusion criteria | Patients aged 18 years and above with a suspected complete digital nerve laceration in any single digit, including thumb and little finger, appropriate for surgical repair |
| Participant exclusion criteria | 1. Bilateral injury (ie both radial and ulnar digital nerves) 2. Laceration outside the region between distal palmar crease and distal interphalangeal joint 3. Closed injury 4. Infected wounds 5. Injuries in which a significant nerve gap exists which would preclude direct tension free surgical end-end repair 6. Non-isolated or multi-level injury (ie common digital/wrist nerve injury, fracture) 7. Unable to give consent 8. Inability to comply with trial follow-up procedures 9. Date of surgery later than 10 days after injury |
| Recruitment start date | 15/09/2020 |
| Recruitment end date | 11/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
Court Road
Chelmsford
CM1 7ET
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Treliske
TR1 3HD
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Address Joint Research Office
Boundary Brook House
Churchill Drive
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 616480 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Protocol will be published before the end of the study recruitment period, other documents will be available on request. Planned publication of the study results in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. situ@ndorms.ox.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 02/07/2020 | 03/05/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
27/11/2024: Contact details updated.
05/06/2023: The participant level data sharing statement was added.
10/05/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2022 to 11/11/2022.
2. The overall end date was changed from 31/12/2023 to 01/12/2023.
3. The intention to publish date was changed from 31/12/2024 to 31/03/2024.
4. The total final enrolment was added.
03/05/2023: Protocol file uploaded.
25/04/2023: The public contact was changed.
01/07/2021: Royal Cornwall Hospital, Royal Derby Hospital, Queen Victoria Hospital, Basingstoke and North Hampshire Hospital, and John Radcliffe Hospital were added as trial participating centres.
12/02/2021: The trial website has been added.
17/09/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 06/04/2020 to 15/09/2020.
2. Frimley Health NHS Foundation Trust, Amersham Hospital, Royal Cornwall Hospital, Royal Derby Hospital, Countess of Chester Hospital NHS Foundation Trust, Walsgrave General Hospital, and Queen Victoria Hospitals NHS Foundation Trust were removed as trial participating centres.
3. Stoke Mandeville Hospital, Broomfield Hospital and University Hospital Coventry were added as trial participating centres.
26/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR) HTA
