POINT: A trial of surgery versus splinting for the treatment of proximal phalanx shaft finger fractures in adults

Plain English summary of protocol

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

Ms Jennifer White
Public

Nottingham Clinical Trials Unit
University of Nottingham
Room A17
Building 42
University Park
Nottingham
NG7 2RD
United Kingdom

Phone	+44 0115 8231586
Email	jennifer.white@nottingham.ac.uk

Dr Alexia Karantana
Scientific

Academic Orthopaedics, Trauma and Sports Medicine, Room WC1378, C Floor, West Block, Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

ORCID ID	0000-0003-3742-5646
Phone	+44 0115 8231115
Email	alexia.karantana@nottingham.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Wales

Study participating centres

Results and Publications

Study outputs

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.