ISRCTN07813725
Completed
未知
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
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust(UK)0 sites170 target enrollmentMay 14, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust(UK)
- Enrollment
- 170
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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