Flexor injury rehabilitation splint trial
| ISRCTN | ISRCTN10236011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10236011 |
| IRAS number | 310986 |
| Secondary identifying numbers | CPMS 52908, IRAS 310986 |
- Submission date
- 13/07/2022
- Registration date
- 20/07/2022
- Last edited
- 03/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Flexor tendons attach to the muscles in our forearms and give us the ability to bend our fingers. In the UK, more than 7000 people a year cut their flexor tendons. Without surgery to repair the tendons, the fingers would never bend and our hands would become useless. Following surgery, a 'made-to-measure' splint is needed to prevent the repaired tendon from re-rupturing. However, people who have had this operation have told us that wearing a splint is awkward and often means they can not work. They also told us that sometimes they do not wear their splint at all. There are currently three splints available on the NHS: long, short and mini. We do not know which of the three splints is best. The aim of the FIRST study is to determine which splint gives people the best chance of getting back their normal hand use, what is it like to wear each splint, if people wear these as instructed, and whether one splint is better value for money.
Who can participate?
Patients aged 16 years and over who have undergone a zone I/II flexor tendon repair
What does the study involve?
Participants will be randomised into 3 groups and given either the long, short or mini splint following their surgery. They will be monitored for a year. We will ask questions about their hand and wrist use and how long they had off work. We will measure how much they can move their hand and how strong their hand is. We will also ask if they have any pain in their hand or wrist, or had any other troubles because of their injury. We will put heat sensors in each splint which will monitor how much they are wearing their splint and each patient will be surveyed to find out what aspects of wearing the splint are important to them. Alongside this, we will interview 20 patients and ask them what it was like to wear the splint, we will ask if they removed their splint and why this was. We will investigate the number of appointments people have had and if they needed any extra operations or treatments to fix their hands. All of this information will be used to understand which splint is best clinically and provides the best value for money.
What are the possible benefits and risks of participating?
The study is providing information in this area as participants will be contributing to important research that will inform treatment choices for patients in future. They will be under close follow-up contact which is normal for those taking part in a research study. All flexor tendon repair patients will have a splint to wear during rehabilitation, whether or not they participate in the study. Splints have the potential risk to be uncomfortable and can cause skin irritation and stiffness. Participants will be provided with site-specific contact details in case they experience any problems with their splint.
Where is the study run from?
University of Sheffield Clinical Trials Research Unit (United Kingdom)
When is the study starting and how long is it expected to run for?
January 2022 to May 2025
Who is funding the study?
National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) (United Kingdom)
Who is the main contact?
Hannah Berntsson (United Kingdom)
h.berntsson@sheffield.ac.uk
Contact information
Scientific
Sheffield Clinical Trials Research Unit
ScHARR The University of Sheffield
Innovation Centre
c/o Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
 ORCID ID |
0000-0002-6285-6985 |
|---|---|
| Phone | +44 (0)114 222 8278 |
| h.berntsson@sheffield.ac.uk |
Principal Investigator
University Hospitals of Derby and Burton NHS Foundation Trust
Royal Derby Hospital
Uttoxeter Rd
Derby
DE22 3NE
United Kingdom
| ORCID ID |
0000-0002-1588-5708 |
|---|---|
| Phone | +44 (0)1332 786985 |
| emma.bamford1@nhs.net |
Public
Sheffield Clinical Trials Research Unit
ScHARR The University of Sheffield
Innovation Centre
c/o Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 8278 |
|---|---|
| h.berntsson@sheffield.ac.uk |
Study information
| Study design | Parallel-group superiority analyst-blind multi-centre individual participant-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prospective randomised controlled trial comparing three splints for finger flexor tendon repairs (FIRST study). |
| Study acronym | FIRST |
| Study hypothesis | The trial hypothesis is that any one of the splints may be superior, in terms of the mean post-randomisation scores (based on data collected at 6, 12, 26, and 52 weeks) for self-reported wrist/hand pain and functioning outcomes, to any of the others. |
| Ethics approval(s) | Approved 07/06/2022, South West - Cornwall & Plymouth Research Ethics Committee (Ground Floor Temple Quay House, 2 The Square, Bristol, BS1 6PN; +44(0)207 104 8071; cornwallandplymouth.rec@hra.nhs.uk), ref: 22/SW/0074 |
| Condition | Injuries and accidents |
| Intervention | The trial will be conducted in approximately 20 hospitals. Patients listed for, or who have undergone surgical repair of zone I/II flexor tendons will be identified from hand clinics/ theatre or hand therapy services and provided with study information. Potentially eligible patients will be given information sheets by delegated site staff and invited to consent at their first clinic visit post-surgery. Recruitment posters and/or business cards directing potential participants to the study website, where the PIS will be available online, will also be available in hand clinics at participating sites. Participants will be randomised to receive either the long, short, or mini splint and will be followed up at 6, 12, 26 and 52 weeks post-randomisation. All follow-up visits will take place in the clinic, with the exception of the 52-week visit which will be done remotely. The Patient-Reported Wrist and Hand Evaluation (PRWHE) questionnaire (primary outcome) will be completed at each follow-up visit. The PRWHE is a 15-item patient-reported outcome for assessing wrist and hand pain/disability on a scale of 0 to 100. The primary outcome will be the mean post-randomisation total PRWHE score. Participants will also be asked to complete questionnaires about their hand and wrist function, general health, quality of life and work productivity and activity. Participants will be asked about any adverse events at each follow-up visit. Range of movement and grip strength will be assessed by site staff blinded to treatment allocation, range of movement at baseline, 6, 12 and 26 weeks and grip strength at 12 and 26 weeks. The project also includes a process evaluation sub-study, which will explore how patient preferences for splint attributes and patient-reported acceptability of splints influence splint adherence. This aspect will involve a survey on participant preferences (stated preferences) at baseline, and on 'revealed' preferences and acceptability of splints at 6 weeks. To understand determinants of nonadherence to the different splints and their associated harm-benefit profiles, 20 partially-nested semi-structured interviews will be conducted, sampling based on splint type and known influential factors such as employment type and dependence on vehicle use. Interviews will be audio-recorded, transcribed and analysed using qualitative techniques. Temperature sensors will be inserted into splints to measure adherence to splint prescription. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Mean post-randomisation total score measured using the Patient Reported Wrist and Hand Evaluation (PRWHE) questionnaire at 6, 12, 26 and 52 weeks post-randomisation |
| Secondary outcome measures | 1. Patient-reported outcomes: 1.1. Level of care received, function, pain and wellbeing measured using the Patient Evaluation Measure (PEM) at baseline, 6, 12, 26 and 52 weeks 1.2. Work productivity and activity impairment (WPAI) score measured at baseline, 6, 12, 26 and 52 weeks 1.3. Quality of life measured using the EuroQoL EQ-5D-5L questionnaire at baseline, 6, 12, 26 and 52 weeks 1.4. Details of any litigation/compensation for injury measured using a study-specific, single-item patient-reported questionnaire at 52 weeks 1.5. Change in general health measured using the global rating of change questionnaire at 6, 12, 26 and 52 weeks 1.6. Preferences for splint attributes (stated and revealed) and splint acceptability measured using study-specific surveys at baseline and 6 weeks 2. Clinical outcomes: 2.1. Range of movement measured using a goniometer and calculated as a Strickland score at baseline, 6, 12 and 26 weeks 2.2. Grip Strength measured using the GripAble tool at 12 and 26 weeks 2.3. Adherence to the splinting protocol measured using a temperature sensor inserted into the participants' splint at baseline and removed at splint removal, at 6 weeks 2.4. Complications and adverse events measured via case report forms completed by site staff throughout participant follow-up |
| Overall study start date | 01/01/2022 |
| Overall study end date | 22/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 429; UK Sample Size: 429 |
| Total final enrolment | 430 |
| Participant inclusion criteria | 1. Aged 16 years old and over 2. Primary repair of zone I/II finger flexor tendon 3. Surgical repairs according to BSSH guidelines |
| Participant exclusion criteria | 1. Patients with associated fractures requiring fixation or additional splintage 2. Tendon lacerations involving 3 or more fingers 3. Revascularization surgery and/or digital nerve reconstructions requiring a nerve graft 4. Presented for treatment more than 3 weeks following the original injury 5. Patients unable to consent or comply with the rehabilitation regime, for example, due to cognitive, psychological or physical disabilities 6. Co-enrolment in another hand trial |
| Recruitment start date | 22/08/2022 |
| Recruitment end date | 22/03/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Truro
TR1 3LJ
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Derby
DE22 3NE
United Kingdom
Seaway Parade Industrial Estate
Baglan
Port Talbot
SA12 7BR
United Kingdom
London
SW10 9NH
United Kingdom
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
Hamilton
ML3 0TA
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Northampton
NN1 5BD
United Kingdom
Amersham
HP7 0JD
United Kingdom
Bath
BA1 3NG
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Hull
HU3 2JZ
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Coventry
CV2 2DX
United Kingdom
East Grinstead
RH19 3DZ
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Cambridge
CB2 0AU
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
| Phone | +44 (0)1332 724639 |
|---|---|
| Uhdb.sponsor@nhs.net | |
| Website | https://www.uhdb.nhs.uk/ |
"ROR" |
https://ror.org/04w8sxm43 |
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 | 30/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. Conference presentation 3. Publication on website 4. Submission to regulatory authorities |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 2.2 | 29/06/2023 | 03/11/2023 | No | No |
| Protocol article | 16/03/2024 | 18/03/2024 | Yes | No |
Additional files
Editorial Notes
03/05/2024: The following changes were made:
1. Total final enrolment was added.
2. The recruitment end date was changed from 31/05/2024 to 22/03/2024.
3. The overall study end date was changed from 31/05/2025 to 22/03/2025.
18/03/2024: Publication reference added.
04/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2024 to 31/05/2024.
2. The overall study end date was changed from 31/01/2025 to 31/05/2025.
14/11/2023: The participant-level data sharing statement was added.
03/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2023 to 31/01/2024.
2. The overall end date was changed from 30/11/2024 to 31/01/2025.
3. The study participating centres Northern Care Alliance NHS Foundation Trust, Cardiff and Vale, Royal Devon and Exeter Hospital, Rotherham NHS Foundation Trust, Salford Royal, and Northern General Hospital were removed and Barts Health NHS Trust, North Bristol NHS Trust, Cambridge University Hospitals NHS Foundation Trust, University Hospitals of Leicester NHS Trust, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Salisbury NHS Foundation Trust were added.
4. The study website was added.
5. Uploaded protocol (not peer-reviewed) as an additional file.
12/09/2022: The recruitment start date has been changed from 01/09/2022 to 22/08/2022.
21/07/2022: Internal review.
13/07/2022: Trial's existence confirmed by NIHR.
