ChiCTR2000033174
尚未开始
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2020-05-23
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关节外Pilon骨折
A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures
A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures
75500
In this multicentre randomised controlled trial we aim to assess ratings of disability 6?months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation. The primary objective is: To quantify and draw inferences on observed differences in the DRI between the trial treatment groups at 6 months after injury. The secondary objectives are: To quantify and draw inferences on observed differences in early functional status at 3 months and later functional status at 12 months. To quantify and draw inferences on observed differences in the radiological outcomes: non-union, mal-alignment and shortening. To identify any differences in health-related quality of life between the trial treatment groups in the first year after injury. To determine the complication rate of intramedullary nail fixation versus locking plate fixation in the first year after injury.
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其它
The method of fixation will be allocated using a secure, centralised, web-based randomisation service. The randomisation service will be available 24 h each day to facilitate the inclusion of all eligible patients.
As the type of fixation used requires clearly visible surgical scars, the patients cannot be blind to their treatment. In addition, the treating surgeons will also not be blind to the treatment, but will take no part in the postoperative assessment of the patients. The functional outcome data will be collected and entered into the trial central database via questionnaire by a research assistant/data clerk in the trial central office. The X-rays collected will be reviewed by an independent assessor.
Nil
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242;233
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2015-10-16
2019-03-20
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Patients will be eligible for this study if: Aged 16 years or over; Patients with a fracture that involves the distal tibial metaphysisdefined as a fracture extending within 2 Müller squares of the ankle joint21are eligible if: The fracture is closed; In the opinion of the attending surgeon, the patient would benefit from internal fixation of the fracture.；
请登录查看Patients will be excluded from participation in this study if: In the opinion of the attending surgeon, there is a contraindication to intramedullary nailing; The fracture is open; There is a contra-indication to anaesthesia; There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires The fracture extends into the ankle joint (ie, intra-articular fracture). Contraindications to intramedullary nailing are: the medullary canal is too narrow OR there is a preinjury deformity of the medullary canal OR it is not possible to achieve fixation of four cortices with screws distal to the fracture. We feel that these exclusion criteria will be easily understood by the surgeons and are in keeping with the pragmatic nature of the trial. However, we will include the specific reason in the trial screening data. For those patients withdrawing from the trial after written consent has been obtained, data obtained up until the point of withdrawal will be included in the final analysis.；
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75500
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