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Distal Radius Internal Fixation Trial

Surgical interventions for treating intra and extra-articular distal radius fractures: a randomised controlled trial of internal fixation with plate & screws versus percutaneous K-wiring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07813725
Enrollment
169
Registered
2014-05-14
Start date
2010-10-01
Completion date
Unknown
Last updated
2020-03-03

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

Conditions

Topic: Musculoskeletal disorders

Interventions

K-wires, The number of K-wires used and whether they are buried or not depends on the surgeon's preference.
Volar plate, The volar approach and a fixed angled locking plate should be used for patients in the ?plate? treatment group.

Sponsors

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust(UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient is skeletally mature (at least 16 years old). 2. The patient has had a low-impact trauma resulting in an isolated distal radius fracture as confirmed by Xray. Lowimpact fractures are those sustained in a fall from no higher than a standing position and at a velocity not above that of running. 3. The fracture is no more than 2 weeks old at the time of surgery. 4. There is no definite contraindication to, or definite indication for, one particular intervention and thus the surgeon is uncertain as to whether to treat the fracture with a plate or with kwiring. 5. NonEnglish speaking patients may be entered if there is a translator present at the time of consent and they have someone to help them fill in the questionnaires

Exclusion criteria

Exclusion criteria: 1. The patient has not given informed consent. 2. The patient is a child under 16 years of age. 3. The patient is not medically fit for surgery. 4. The fracture has previously been treated. 5. There is major displacement of articular fragments or obvious ligament injury. 6. The fracture is not displaced or is minimally displaced so that conservative treatment rather than surgery is considered appropriate. 7. If the fracture is accompanied by a compound injury with a Gustillo grading of 2 or higher. 8. The patient is unlikely to or unable, due to a cognitive impairment (as defined by the medical team responsible, this includes drug/alcohol abuse), to provide consent and complete questionnaires. 9. If the patient is not able to complete a year of followup Patients not eligible for the study will receive clinical care and treatment as they would per normal clinical practice.

Design outcomes

Primary

MeasureTime frame
Disability of Arm Shoulder and Hand Questionnaire functional score at baseline, 3, 6 and 12 months

Secondary

MeasureTime frame
1. EQ5D Questionnaire at baseline, 3, 6 and 12 months 2. Patient Diary kept for three most post-surgery 3. Patient Related Wrist Evaluation Questionnaire functional score at baseline 3, 6 and 12 months 4. Resource Usage Questionnaire at baseline, 3, 6 and 12 months 5. X-ray review at 3 and 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026