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临床试验/NCT03172923
NCT03172923已完成不适用

Randomised Trial of Trochanteric Hip Fractures Treated With Either a Sliding Hip Screw on an Intramedullary Nail

Peterborough and Stamford Hospitals NHS Foundation Trust0 个研究点目标入组 400 人开始时间: 2010年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
主要终点
regain of mobility

研究概览

简要总结

The investigators therefore propose to undertake a further randomised controlled trial comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to see if the summation of the first trial of 600 participants comparing the sliding hip screw with the Targon PF nails, in conjunction with this study of 400 participants with the updated Targon PFT nail produces results that convincingly demonstrate that this particular design of implant is superior to the sliding hip screw. Because of the financial issues involved a cost benefit comparison for the two procedures is planned at the completion of the study.

Primary outcome measures will be regain of walking ability. Secondary outcome measures recorded with include mortality, length of surgery, operative blood loss, blood transfusion, post-operative complications, hospital stay, need for subsequent revision surgery and degree of residual pain.

详细描述

The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.

In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of MJP. Those patients that are willing to participant in one of our randomised trials are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.

The sliding hip screw used if of a standard design that has been in use at Peterborough for the last fifty years. The intramedullary nails used will be the Targon PFT nail. This nail is very similar to the Targon PF nail used in the earlier trial on this topic. Bases on the results of the previous study and the experience of other users the nail has undergone minor modifications that are primarily aimed at making the nail easier to use with improved instrumentation and also a change to design of the cross screw aimed at reducing the risk of fracture fixation complications occurring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

outcome assessor is blinded to treatment given

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted to Peterborough District Hospital with a trochanteric hip fracture that is to be treated by internal fixation.

排除标准

  • Patients who decline to participate
  • Patients without the capacity to give informed consent
  • Patients admitted when MJP is not available to supervise treatment
  • Patients with pathological fractures from Paget's disease of bone secondaries from tumour

研究组 & 干预措施

intramedullary nail

Experimental

fixation of the fracture with an intramedullary nail

干预措施: intramedullary nial (Device)

sliding hip screw

Active Comparator

fixation of fracture with a sliding hip screw

干预措施: sliding hip screw (Device)

结局指标

主要结局

regain of mobility

时间窗: one year from injury

regain of walking ability using a standardised mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg 1993;75-B:797-8.)

次要结局

  • mortality(at one year from injury)

研究者

发起方
Peterborough and Stamford Hospitals NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martyn J Parker

Consultant orthopaedic surgeon

Peterborough and Stamford Hospitals NHS Foundation Trust

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