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

Category Primary study
Registry of TrialsISRCTN registry
Year 2020
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). CONDITION: Proximal phalanx shaft finger fractures ; Musculoskeletal Diseases ; Fracture of finger PRIMARY OUTCOME: 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: ; 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.; 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
Epistemonikos ID: d26da7a93b919486bd0314a776b2b5571f6fa20b
First added on: Aug 24, 2024