Proximal phalanx shaft finger fractures Musculoskeletal Diseases Fracture of finger
Conditions
Interventions
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
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 f
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactJennifer White
Outcome results
None listed