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Scaphoid Waist Internal Fixation for Fractures Trial: A trial evaluating cast versus surgical fixation for fractures of the scaphoid waist in adults

A multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of cast treatment versus surgical fixation for fractures of the scaphoid waist in adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67901257
Enrollment
438
Registered
2013-02-13
Start date
2013-04-01
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal trauma of the hand and wrist Musculoskeletal Diseases

Interventions

Participants will be randomised to one of two basic treatment interventions: 1. Surgery using a headless screw 2. Plaster cast immobilisation

Sponsors

University Hospitals of Leicester NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults (male and female), aged 16 years old or above 2. Presenting to the trauma centre within 2 weeks of their injury 3. Radiologically confirmed bicortical fracture of the scaphoid waist

Exclusion criteria

Exclusion criteria: 1. Fractures greater than 2mm displaced 2. Fractures in the proximal pole of the scaphoid (proximal 20%) 3. Trans-scaphoid perilunate dislocation 4. Multiple injuries in the same limb 5. Previous injury or disease in the same wrist 6. Patients with cognitive impairment 7. Patients not resident in the trauma centre catchment area 8. Any other reason to exclude the patient (please give reasons)

Design outcomes

Primary

MeasureTime frame
The Patient Rated Wrist Evaluation (PRWE) (15 item condition-specific questionnaire providing a total score based on the patient's subjective assessment of wrist pain and disability in activities of daily living), assessed at 52 weeks

Secondary

MeasureTime frame
1. The PRWE at 6, 12 and 26 weeks and at 5 years 2. The 12-item short form health survey (SF-12) and Euroqol (EQ-5D) for general health status data (at 6, 12, 26, 52 weeks and 5 years) 3. Bone union, determined by CT scan and radiographs at 52 weeks and 5 years 4. Range of wrist movement (measured using goniometer at 6, 12, 52 weeks and 5 years). 5. Grip strength (measured using a calibrated Jamar dynamometer at 6, 12, 52 weeks and 5 years) 6. Complications, including surgical complications (e.g. wound infection) at 6, 12, 52 weeks 7. Early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism. 8. Subsequent referral for operation or substantive treatment. Duration of follow-up: 5 years 9. Data for economic evaluation: NHS and societal costs

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 13, 2026