ISRCTN07813725已完成未知

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 个研究点目标入组 170 人开始时间: 2014年5月14日最近更新: 2020年3月3日

试验速览

暂无简介。

•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

•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.

发起方

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