nstable fractures of the distal radius: a randomised prospective clinical study comparing their treatment with volar locking plate and conventional method

ottingham University Hospitals NHS Trust (UK)0 个研究点目标入组 122 人开始时间: 2009年9月8日最近更新: 2015年1月13日

试验速览

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•1. Fractures which the referring physician considers require operative intervention
•2. Configuration is such that the fracture would be amenable to stabilisation via volar locking plate (not massively comminuted)
•3. Adults (skeletally mature) with high demand requirements of their wrist in whom the radiological appearance of the bone suggests that it is robust enough to tolerate internal fixation; and in whom the fracture pattern at presentation fulfils the criteria as described below
•4. Fractures of the distal radius which are:
•4.1. Dorsally displaced extra-articular fractures (with or without an undisplaced intra-articular component) with dorsal cortical comminution as seen on the lateral radiograph
•4.2. Displaced intra-articular fractures with an articular step or gap in the radio-carpal joint surface
•5. Skeletally mature adults, minimum age 16 years and above, either sex

•1. Patients with concomitant systemic diseases (diabetes with vascular or neurological complications, advanced cardiac, pulmonary or neurological disease)
•2. Proximal metaphyseal fractures (more than one inch or 2.5 centimetres from the articular surface)
•3. Open fractures
•4. Smith's and volar Barton's configuration
•5. Previous fractures of the distal radius of the same or contra-lateral limb less than six months old
•6. Significant pre-existing radiological abnormality
•7. Multiply injured
•8. Bilateral injuries
•9. Patients who are unable to consent for themselves to treatment
•10. Patients who may have difficulties in adequate understanding of English

发起方

ottingham University Hospitals NHS Trust (UK)