A comparison of surgical and non-surgical management of thumb osteoarthritis
| ISRCTN | ISRCTN76656598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76656598 |
| IRAS number | 336574 |
| Secondary identifying numbers | NIHR 154694, CPMS 64089, IRAS 336574 |
- Submission date
- 15/08/2024
- Registration date
- 29/08/2024
- Last edited
- 16/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Several different treatments are available for clinicians to use with patients who have osteoarthritis in the base of their thumb. The SCOOTT study aims to find out if there is any difference in outcome for patients with base of thumb osteoarthritis by comparing three different treatments. The first treatment is non-surgical, it involves a specialist-enhanced hand therapist-led package. The second treatment is a trapeziectomy (surgical). The third treatment is a thumb joint replacement (surgical). It is unknown which of these treatments works best in improving patients’ thumb base pain. This research study aims to find out which treatment is best.
Who can participate?
Adults with symptomatic base of the thumb osteoarthritis can take part in this study if their treating clinician thinks that any of the treatments available in this study would be suitable for them.
What does the study involve?
Taking part in the study means that the participants' treatment will be decided by a scientific process called randomisation. The process is commonly used in research to help us work out which treatment is best. Participants will receive either the ENGAGE package, a trapeziectomy or a thumb joint replacement. Participants will be asked to complete 8 questionnaires over 18 months to find out how they are doing. Some of these can be done at home, online or over the phone, and some of them will be part of a clinic appointment as they will also involve measurements such as thumb range of movement and grip strength. Participants will receive two £15 vouchers as a thank-you for completing follow-ups in the study. Participants might also be invited to interview with a researcher.
What are the possible benefits and risks of participating?
Treatment for the base of thumb osteoarthritis can only be improved with the help of patients. Taking part in this study means that you could help improve the care of future patients who need treatment for the base of thumb osteoarthritis. There is no increased risk to you by participating in the study. The NHS has treated patients with the treatments that are compared in this study. Participants will face the same surgical and anaesthetic risks (if they receive a surgical treatment) and receive the same care as patients who have any of these treatments without taking part in the study.
Where is the study run from?
York Trials Unit at the University of York (UK) manages the day-to-day running of the study
When is the study starting and how long is it expected to run for?
January 2024 to December 2027
Who is funding the study?
The National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (HTA)
Who is the main contact?
Emma Reay, emma.reay1@nhs.net
Contact information
Scientific, Principal Investigator
Trauma & Orthopaedics, The James Cook University Hospital, Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 850850 |
|---|---|
| emma.reay1@nhs.net |
Scientific, Principal Investigator
University Hospitals of Derby and Burton NHS Foundation Trust
Pulvertaft Hand Centre
Royal Derby Hospital
Kings Treatment Centre
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
| nick.johnson3@nhs.net |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Surgery versus Conservative OsteOarthritis of Thumb Trial (SCOOTT). An RCT to determine clinical and cost effectiveness of treating arthritis of the base of the thumb, with or without surgery, and to determine the clinical and cost effectiveness of trapeziectomy versus base of thumb joint replacement |
| Study acronym | SCOOTT |
| Study objectives | 1. There is no difference in the AUSCAN score at 12 months post-randomisation between adults (≥16 years old) with BTOA treated with surgery versus non-surgical management. 2. CMCJR is inferior to trapeziectomy for the treatment of BTOA in adult patients (≥16 years old) as measured by the AUSCAN score at 12 months post-randomisation. |
| Ethics approval(s) |
Approved 29/08/2024, Wales Research Ethics Committee 2 Cardiff (Health and Care Research Wales, 5 Castlebridge, Cardiff, CF11 9AB, United Kingdom; -; wales.rec2@wales.nhs.uk), ref: 24/WA/0237 |
| Health condition(s) or problem(s) studied | Base of the thumb osteoarthritis |
| Intervention | This study is a randomised controlled trial which aims to recruit 656 adults with basal thumb osteoarthritis who have been referred to secondary care. Recruitment will take place over 2 years from approximately 20 NHS trusts across the UK. Participants will be randomised to one of three treatment options: (1) Trapeziectomy surgery, (2) Thumb joint replacement surgery, or (3) ENGAGE therapy package (non-surgical). Recruitment: The research team will work closely with the clinicians and research staff at each recruiting site to optimise the screening and recruitment procedures for their local circumstances. All members of staff involved in eligibility sign-off and the informed consent process (including surgeons) will have training in Good Clinical Practice (GCP) or study-specific training. The NIHR Associate Principal Investigator (API) scheme will be utilised at participating sites to involve aspiring researchers to co-ordinate study recruitment. The APIs will be trained in study processes and will be supervised by the PI at the site. Potential participants will be provided with information about the study including a patient information sheet (PIS) at the earliest possible opportunity following presentation. Consent: Consent will be recorded via paper consent forms, which will be uploaded onto the secure web-based data collection interface ‘REDCap’ once complete, or via participant e-consent directly within the REDCap system. Informed consent will be obtained by an authorised and trained member of the trust research team or clinical staff. Baseline data collection: Once participant eligibility has been confirmed and consent has been obtained, a baseline visit will be completed to collect all baseline data. The following measures will be collected at baseline: • Demographic measures collected via patient self-report: ethnicity, education, employment status, housing/accommodation status. • Questionnaire measures: Australian/ Canadian Osteoarthritis Hand Index (AUSCAN) questionnaire, PEM Score, EuroQol 5 dimensions (5L) score (EQ-5D-5L) and Patient satisfaction • Physical measures: Total range of motion (radial and palmar abduction), Kapandji opposition score, Grip strength and Key pinch strength. • Grade/severity of OA and condition history • Date of birth Randomisation: Following the baseline assessment, randomisation will be undertaken by a member of the Trust’s research team using REDCap. The outcome of the allocation will be communicated to the participant where possible in person but may also be communicated via telephone or email. Follow-up data collection. Follow-up data collection will involve participants completing questionnaires (which can be done remotely), but for some time points, there will be physical measurements too which will require them to attend a clinic appointment. Follow-up time points will be 6, 12* and 18 months after the date of randomisation and Day of treatment*, 6 weeks*, 3 months, and 6 months* after the date of treatment. Those marked with an asterisk will be required to attend a clinic visit. Qualitative interviews There will be a nested qualitative interview study within the trial which will look at the experience and acceptability of the interventions. Approximately 10-15 participants from each of the three treatment arms will be selected and approached for interview. In addition, interviews will be conducted with approximately 15-20 clinicians (hand surgeons/ hand therapists and occupational therapists). These will include those who were involved in the trial and also those who were outside of the trial delivery. Written or verbal consent will be taken for all interview participants prior to the start of each interview. Where verbal consent is taken, this will be recorded by the research team separately from the interview. Patient and public involvement and engagement (PPIE) The SCOOTT PPIE group have contributed to the design of the trial, the intervention components, participant-facing study documents and the ENGAGE intervention resources |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain is measured using the AUSCAN hand pain index at 12 months post-randomisation |
| Secondary outcome measures | 1. Pain is measured using the AUSCAN hand pain index and the PSEQ-2 at baseline, day of surgery/therapy, 6 weeks, 3 months and 6 months post treatment, 6 months, 12 months (PSEQ-2) and 18 months post randomisation 2. Hand function is measured using the AUSCAN hand function and stiffness index and the PEM score at baseline, day of surgery/therapy, 6 weeks, 3 months and 6 months post treatment, 6 months, 12 months and 18 months post randomisation 3. Range of motion is measured using the Kapandji score and Goniometry at baseline, 6 weeks and 6 months post treatment and12 months post randomisation. 4. Grip and Pinch strength is measured using Jamar dynamometers at baseline, 6 months post treatment and 12 months post randomisation 5. Healthcare and broader resource implications and comparative cost-effectiveness are collected from participant self-reports and hospital-completed forms at baseline, 6 weeks, 3 months and 6 months post treatment and 6 months, 12 months and 18 months post randomisation. 6. Health-related quality of life is measured by EQ-5D-5L at baseline, day of surgery/therapy, 6 weeks, 3 months and 6 months post treatment, 6 months, 12 months and 18 months post randomisation 7. Patient acceptability is measured by a global question at day of surgery/therapy, 6 weeks, 3 months and 6 months post treatment, 6 months, 12 months and 18 months post randomisation as well as with qualitative interviews during the follow up period 8. Complications are measured by reporting of complications and adverse events at 6 weeks, 3 months and 6 months post treatment, 6 months, 12 months and 18 months post randomisation |
| Overall study start date | 01/01/2024 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 656; UK Sample Size: 656 |
| Key inclusion criteria | 1. Aged 16 years old and over 2. Symptomatic basal thumb osteoarthritis 3. The treating clinician thinks the patient would benefit from surgical intervention 4. The patient is suitable for both types of surgery 5. Able to consent to a surgical procedure |
| Key exclusion criteria | 1. Inflammatory arthritis 2. Current or past infection around the base of the thumb 3. Previous surgery on the affected thumb joint 4. Any comorbidity which precludes them from undergoing surgical intervention |
| Date of first enrolment | 17/12/2024 |
| Date of final enrolment | 30/06/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Middlesbrough
TS4 3BW
United Kingdom
Derby
DE22 3NE
United Kingdom
Reading
RG1 5AN
United Kingdom
Turner Road
Colchester
CO4 5JL
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Wigan
WN1 2NN
United Kingdom
Liverpool
L7 8XP
United Kingdom
Sponsor information
Hospital/treatment centre
Research Governance Manager, STRIVE Academic Centre, The James Cook University Hospital
Middlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 (0)7788 360 287 |
|---|---|
| david.rollins@nhs.net | |
| Website | https://www.southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The protocol will be published on the NIHR HTA website and in an open-access journal. On completion of the study, publication of the main paper will be undertaken in a high-impact peer-reviewed journal with the intent to publish Dec 2028. The study team have identified three key target audiences for dissemination: Patients, the PPIE group will help generate a plain language summary and the study team will work with arthritis charities to reach BTOA sufferers with information about our findings. A dedicated trial website, which will be open to all participants and their carers, will have up-to-date information on the progress of the study and subsequently the results. Policymakers, the study will be registered and the protocol, statistical and health economics analysis plan and results, will be published in high-impact open-access journals. Publications will be targeted to inform commissioning decisions, and the study team will work with NICE, the BSSH, BAHT and healthcare commissioners to inform national guidelines. This will be in collaboration with our PPI group. Healthcare workers, our study group contains well-placed members to disseminate findings and implement change through membership of national specialist society committees – including BSSH, British Association of Hand Therapists (BAHT), British Orthopaedic Association (BOA) and RCS. The study team will disseminate results at the annual meetings of these specialist societies as well as at the general BOA Conference. Slide decks of results will be made available to all PIs to enable local and regional presentation of results at each participating site. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study (fully anonymised) will be available upon request after the publication of the study results from Prof. Catherine Hewitt (catherine.hewitt@york.ac.uk). Requests for access to data will be reviewed by the co-Chief Investigators, study Sponsor and trial team. Participants will be informed that information collected about them may be shared anonymously with other researchers and will be asked to consent to this. |
Editorial Notes
16/01/2025: The recruitment start date was changed from 31/10/2024 to 17/12/2024.
12/09/2024: The following changes were made:
1. Ethics approval date given.
2. The recruitment start date was changed from 30/09/2024 to 31/10/2024.
15/08/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
