POINT: A trial of surgery versus splinting for the treatment of proximal phalanx shaft finger fractures in adults
ISRCTN | ISRCTN88266404 |
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DOI | https://doi.org/10.1186/ISRCTN88266404 |
IRAS number | 277440 |
Secondary identifying numbers | IRAS 277440 |
- Submission date
- 17/01/2020
- Registration date
- 20/01/2020
- Last edited
- 08/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
This study investigates the treatment of a common type of bone break in the section of the finger closest to the knuckle. This injury is called a proximal phalanx shaft finger (PPS) fracture. PPS fractures result from falls, twisting forces or blows to the hand. They are treated in hospital by hand specialists which involves multiple visits to hospital and recovery takes several weeks to months, during which use of the hand is restricted. The aims of treatment are bone healing in good position, prevention of stiffness and return to full function. Although many people heal well, some fractures cause permanent pain, finger stiffness or deformity, which limit use of the hand and affect the way the finger looks. Serious problems need further treatment, including complex surgery. AIM PPS fractures can be treated with or without surgery and we don't know which is best. Current treatment is based on what each specialist believes works best and can vary. NHS hand specialists, patients with PPS fractures and researchers worked together to plan this study, so that a fair and useful comparison of treatments can be made. We will compare two treatments: surgery using metalwork (pins, screws or plates) to fix the fracture versus treatment using finger splints applied in clinic, but sometimes requiring local anaesthetic to improve the fracture position. The aim is to improve care by finding out which treatment is better for the patient; also which represents best value for money.
Patients and the public were involved in prioritizing the research question via the James Lind Alliance Priority Setting Partnership on Common Conditions of the Hand and Wrist. Patients with PPS fractures were actively involved in the study design via a national workshop with clinicians and researchers and two patient focus groups. We established a patient representative group to support our patient co-applicant, who has experienced a PPS fracture treated in the NHS. Two patient representatives will also help oversee the study.
Who can participate?
Adult patients with one or more proximal phalanx shaft finger fracture(s) suitable for surgical or non-surgical splint treatment.
What does the study involve?
Participants will be approached and recruited in secondary care fracture clinics. After giving informed consent to participate in the trial, participants will be randomly assigned to either receive surgery or non-surgical splint treatment. Any other treatment decisions (such as the type of surgery or splint, when to move the finger or take x-rays) will be made by the specialists and the patient, as is done in usual care outside the study.
Participants will be asked to complete questionnaires about how well they can use their hand and their general health (online or by post) at 6 weeks, 6 months and 12 months after joining the study. The primary outcome for the study will be a comparison of a patient completed questionnaire - Patient Evaluation Measure (PEM) at 6 months, compared to the start of the study.
Participants will also be asked to attend a trial clinic visit at 3 months where data will be collected and tests on hand function will be performed (range of motion, grip and pinch strength).
What are the possible benefits and risks of participating?
Possible benefits: You will receive the same level of care from your doctors, whether you choose to participate in the study or not. You may not benefit personally from taking part in this study, but because of the contact with the research team, you will have more regular or frequent opportunity to discuss your PPS finger fracture.
By taking part in this study you will also help to improve the treatment of future patients presenting with a PPS finger fracture. This means that people with such a fracture may in future experience a quicker or more convenient recovery, have fewer complications and better long-term use of their hand. The results of the study will also help plan effective services offered by the NHS.
Possible risks: Both treatments are a part of standard NHS care, so there is no extra risk involved in receiving them as part of the study. We do not know which of these treatments is best for patients with PPS finger fractures which is why we are doing this study. Taking part will mean spending some time to complete questionnaires and one extra visit to the hand clinic at hospital, three months after your first appointment.
Where is the study run from?
Nottingham Clinical Trials Unit, University of Nottingham (UK) and 13 Acute Care NHS Trusts (UK).
When is the study starting and how long is it expected to run for?
September 2019 to February 2024
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Jennifer White, point@nottingham.ac.uk
Contact information
Public
Nottingham Clinical Trials Unit
University of Nottingham
Room A17
Building 42
University Park
Nottingham
NG7 2RD
United Kingdom
Phone | +44 0115 8231586 |
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jennifer.white@nottingham.ac.uk |
Scientific
Academic Orthopaedics, Trauma and Sports Medicine, Room WC1378, C Floor, West Block, Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
0000-0003-3742-5646 | |
Phone | +44 0115 8231115 |
alexia.karantana@nottingham.ac.uk |
Study information
Study design | Pragmatic, multi-center, parallel, two-arm, superiority randomized trial |
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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 contact details to request a participant information sheet |
Scientific title | Surgery versus non-surgical splint treatment for proximal phalanx shaft fractures |
Study acronym | POINT |
Study hypothesis | To determine the clinical and cost-effectiveness of surgery compared to non-surgical splint treatment for Proximal Phalanx Shaft (PPS) finger fractures in adults |
Ethics approval(s) | Approved 11/03/2020, North of Scotland Research Ethics Service (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224558458; gram.nosres@nhs.scot), ref: 20/NS/0030 |
Condition | Proximal phalanx shaft finger fractures |
Intervention | Patients with a PPS fracture coming to hospital will be invited to take part in the study. Patients will then be treated in one of two groups: treatment with surgery OR non-surgical treatment using a finger splint. Each participant will have an equal chance of being in either group; neither the participant nor the specialist will be able to choose, this will be decided randomly by a computer. Any other treatment decisions (such as the type of surgery or splint, when to move the finger or take x-rays) will be made by the specialists and the patient, as is done in usual care outside the study. Participants will be asked to complete online or postal questionnaires at the start of the study, and at 6 weeks, 6 months and 12 months after joining the study. Participants will also be asked to attend a trial clinic visit at 3 months where data will be collected and tests on hand function will be performed (range of motion, grip and pinch strength). |
Intervention type | Mixed |
Primary outcome measure | Participant-reported assessment of hand function measured using the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 6 months post-randomization |
Secondary outcome measures | 1. Participant reported assessment of hand function and appearance, using the Hand Health Profile of the PEM questionnaire at 6 weeks, 3 months, and 12 months. 2. Participant-reported assessment of location-specific health (the hand) using the Single Assessment Numeric Evaluation (SANE) tool at 6 weeks, 3 months, 6 months and 12 months. 3. Participant-reported quality of life assessment, using the EQ-5D-5L questionnaire, at 6 weeks, 3 months, 6 months and 12 months. 4. Participant-reported assessment of upper extremity function, using the Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive test, at 6 weeks, 3 months, 6 months and 12 months. 5. Participant-rated appearance of the hand as per item 10 of the Hand Health Profile of the PEM. 6. Investigator assessed active range of motion of affected digit(s), using a finger goniometer at 3 months. 7. Investigator assessed palmar grip and pinch strength of the affected hand, using a hydraulic dynamometer and pinch meter at 3 months. 8. Resource use and costs, assessed by a health economic analysis of health & social services costs (primary analysis) and effects on families and society (secondary analysis). 9. Participant and investigator reported complications, including need for further surgery, recorded in the Case Report Form and participant questionnaire responses. |
Overall study start date | 01/09/2019 |
Overall study end date | 29/02/2024 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 16 Years |
Sex | Both |
Target number of participants | 400 |
Total final enrolment | 113 |
Participant inclusion criteria | Current participant inclusion criteria as of 12/04/2022: 1. ≥1 Proximal Phalanx shaft finger fracture of any configuration 2. Aged ≥16 years 3. The fracture could be treated via either surgery or non-surgical splint treatment 4. Willing and able to give fully informed consent Previous participant inclusion criteria: 1. Patients with one or more proximal phalanx shaft finger fracture(s) 2. Age ≥16 years 3. Fracture(s) suitable for either surgery or non-surgical splint treatment as assessed by the investigator 4. Willing and able to give fully informed consent |
Participant exclusion criteria | Current participant exclusion criteria as of 12/04/2022: 1. Injury >14 days old at the anticipated time of treatment 2. Pure Basal metaphyseal fracture 3. Pure Phalangeal neck fracture 4. Open fracture 5. Fracture pattern extending into the joint surface 6. Would not be able to adhere to trial procedures or complete the study questionnaires Previous participant exclusion criteria: 1. Fracture(s) occurring ≥14 days before the anticipated time of treatment 2. Open fracture(s) 3. Basal metaphyseal fracture(s) 4. Phalangeal neck fracture(s) 5. Fracture patterns that extend into the joint surface 6. Inability to adhere to trial procedures or complete the study questionnaires |
Recruitment start date | 01/04/2020 |
Recruitment end date | 31/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Room A17
Building 42
University Park
Nottingham
NG7 2RD
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Rotherham
S60 2UD
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Bath
BA1 3NG
United Kingdom
Harton Lane
South Shields
NE34 0PL
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Whielden Street
Amersham
HP7 0JD
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Sponsor information
University/education
Research and Innovation
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
England
United Kingdom
Phone | 01158467906 |
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sponsor@nottingham.ac.uk | |
Website | https://www.nottingham.ac.uk/fabs/research-innovation/home.aspx |
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 | 31/08/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Research findings will be disseminated via a HTA monograph in the NIHR Journals library, scientific papers, conference presentations, and communicated to groups involved in guideline development and commissioning decisions. Trial publications and conference presentations will be submitted to the NIHR HTA for approval prior to submission to the event organisers or the editors. All publications will acknowledge the support of the HTA in funding this trial. All participants will receive a copy of the trial results (unless they have stated they do not wish to receive this). Neutral or negative results will not constitute a reasonable justification to delay publication. |
IPD sharing plan | The datasets analysed during the current study will be available upon request from the NCTU (ctu@nottingham.ac.uk), a minimum of 6 months after publication of the main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the CI and sponsor, and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be pseudoanonymised which may impact on the reproducibility of published analyses. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/08/2023: The intention to publish date has been changed from 01/12/2024 to 31/08/2024.
07/08/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2024 to 31/01/2023.
2. The overall study end date has been changed from 01/11/2025 to 29/02/2024 and the plain English summary updated accordingly.
3. The final enrolment number has been added.
13/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2022 to 31/05/2024.
2. The overall trial end date was changed from 01/08/2023 to 01/11/2025.
12/04/2022: The following changes have been made:
1. The ethics approval has been added.
2. The participant inclusion criteria have been updated.
3. The participant exclusion criteria have been updated.
4. The individual participant data (IPD) sharing statement has been added.
05/04/2022: The recruitment end date was changed from 01/03/2022 to 01/09/2022.
17/01/2020: Trial’s existence confirmed by the National Institute for Health Research.