Title: POINT: A multi-centre randomised trial of surgery versus non-surgical splint treatment for proximal phalanx shaft finger fractures in adults
Funder: Department of Health and Social Care

Abstract: BACKGROUND_x000D_ 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._x000D_ 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._x000D_ _x000D_ AIM_x000D_ 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._x000D_ 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._x000D_ _x000D_ DESIGN AND METHODS_x000D_ 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._x000D_ To find out how well the treatment works, we will ask participants to complete questionnaires (online or by post) about how well they can use their hand and their general health at 6 weeks, 3 months, 6 months (most important time point) and at 1 year; and record any treatments they received and any complications. We will also carry out a physical examination of the hand at 3 months during a clinic visit._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT_x000D_ Patients and the public were involved in prioritising 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._x000D_ _x000D_ DISSEMINATION_x000D_ Results will be published in medical journals, discussed at conferences and contribute to guidelines by national organisations. We will inform study participants and patients organisations of the results and study impact. With our patient members, we will develop information for patients and the public, hosted on appropriate public websites and social media.

Lay abstract: RESEARCH QUESTION: What is the clinical and cost effectiveness of surgical treatment for proximal phalanx shaft (PPS) finger fractures in adults compared to non-surgical treatment using splints?_x000D_ BACKGROUND: PPS finger fractures are common and can impair hand function. There is no evidence on whether they are best treated by surgical fixation or non-surgically using splints. Both methods are standard care in the NHS, treatment is based on what each specialist believes works best and can vary. _x000D_ PRIMARY OBJECTIVE: To compare hand function between surgical and splint treatment at 6 months post treatment._x000D_ SECONDARY OBJECTIVES: To compare hand function between surgical and splint treatment at 6 weeks, 3 and 12 months; to determine the complication rate, including need for further surgery within 12 months and to compare Health-related Quality of Life, health resource use and cost-effectiveness between surgical and splint treatment at 12 months._x000D_ DESIGN: Pragmatic multi-centre, parallel two-arm superiority randomised trial. Internal pilot phase of 10 months to review expected rate of recruitment, with a second review at 14 months to assess primary outcome follow-up._x000D_ SETTING: Acute Care NHS Trusts_x000D_ STUDY POPULATION: Included are adults with one or more proximal phalanx shaft fractures of the fingers (index, middle, ring, little), which the treating specialist believes can be treated either by surgery or non-surgical splint treatment. _x000D_ Excluded are patients with an injury 14 days or older, open fractures or who are unable to adhere to trial procedures or complete questionnaires. Patients with concomitant injuries are included; additional injuries will be recorded at baseline and the analysis adjusted as necessary._x000D_ PRIMARY OUTCOME: Hand health profile of the Patient Evaluation Measure (PEM) at 6 months post treatment._x000D_ SECONDARY OUTCOMES: Patient-reported Single Assessment Numeric Evaluation (SANE), EQ-5D-5L, PROMIS PROM Upper Limb CAT, active range of movement, grip and pinch strength, complications, resource use and return to work _x000D_ SAMPLE SIZE: 400 participants (200 per arm), recruited over 24 months from 15 sites to enable detection of a 3 point between group difference in the PEM._x000D_ URL: www.nottingham.ac.uk/nctu

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS