Unstable fractures of the distal radius in patients aged 65 years and older Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged =65 years 2. Dorsally angulated fractures of the distal radius 3. The treating surgeon believes the patient is suitable for surgical fixation 4. Operation date within 3 weeks of fracture 5. Closed or Gustilo-Anderson grade I injury
Exclusion criteria
Exclusion criteria: 1. Patients unable to give informed consent 2. Patients medically unfit to undergo surgery 3. Volar displaced fractures 4. Partial articular and isolated radial styloid fractures 5. Associated fractures to the upper limb and/or pre-existing pathology adversely affecting function 6. Associated ligamentous injury, dislocation or subluxation of the wrist 7. Open fractures of Gustilo-Anderson grade II or higher 8. Persisting neurovascular deficit requiring operative intervention 9. Off-ended/severely displaced fractures post attempted reduction that are deemed to require surgery by the treating surgeon 10. Non-residents who will be unable to attend for local follow-up 11. Patients unable to comply with follow-up, including English-language patient-reported outcome measures, either on the telephone or by post
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrist pain and disability assessed using the Patient-Rated Wrist Evaluation (PRWE) at 1 year (52 weeks) post-injury | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wrist pain and disability assessed using the Patient-Rated Wrist Evaluation (PRWE) at 12 and 26 weeks 2. Health-related quality of life measured using EuroQol 3 Dimensions (3L) Score (EQ-5D-3L) at 12 weeks, 26 weeks and 52 weeks 3. Physical function of the upper limb measured using the Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) score at 12 weeks, 26 weeks and 52 weeks 4. Pain assessed by VAS pain score at 2 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks 5. Healthcare resource use, and comparative cost-effectiveness at 1 year (52 weeks) using data collected from patient interviews and questionnaire responses and appropriate statistical and economic analysis methods 6. Complication rate obtained by patient questionnaire responses and reviewing patient notes at 1 year (52 weeks) 7. Grip strength assessed using a dynamometer at 12 weeks 8. Wrist range of motion assessed using a goniometer at 12 weeks 9. Radiographic parameters (including radial inclination, radial height, ulnar variance, carpal malalignment, dorsal tilt, intra-articular step and intra-articular gap) assessed using X-ray imaging at 2 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks | — |
Countries
Scotland, United Kingdom