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临床试验/NCT03906032
NCT03906032已完成不适用

Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture

University Hospital Waterford1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Kinmeatic Gait parameters at Hip

研究概览

简要总结

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence, gait speed and increased double support time on the injured side.

The use of an IM nail device may reduce shortening and improve functional parameters in this patient cohort

详细描述

Published work in this field to date has not demonstrated an advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current literature focus on outcome questionnaires, pain scores and basic functional tests alone may not delineate all functional benefits. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem.

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence and increased double support time on the injured side.

The cost differential between a nail and a SHS is a barrier to routine use of nailing in this population unless a clear benefit is demonstrated. Fracture nonunion is uncommon in this injury however improving functional outcome and reducing morbidity and mortality in this group is important.

In this prospective randomised study, the investigators examine whether an intramedullary nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS, in terms of gait speed and other objective gait assessments, as well as other established post operative outcome measures.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Simple randomization technique using an online random number generator will be utilized. Sequential sealed envelopes with group allocation will be opened at the time of the daily trauma meeting and the appropriate plan made for the patient. Patients are randomized according to 3 mobility groups - independent, walking stick/crutch or walking frame.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • OTA Hip fracture grade A1 and A2
  • Greater than 18 years old

排除标准

  • Fracture less than 18 yrs old
  • Fracture with lateral wall trochanteric comminution
  • Poltrauma
  • Concurrent lower limb fractures
  • Immobile/wheelchair/bedbound patients
  • High energy hip fractures
  • Pathological fractures
  • Reverse oblique and sub-trochanteric femoral fractures which are considered obligate TFNA at our centre
  • Open wounds on affected limb
  • Active psoriasis or other dermatological conditions at affected area
  • Unable to gain consent from patient or patient's NOK

结局指标

主要结局

Kinmeatic Gait parameters at Hip

时间窗: 6 months

Rate of change in hip kinematic profile between baseline and subsequent time points,

次要结局

  • Length of stay(Through to study completion at one year post operatively.)
  • Change in Heamoglobin concentration post surgery(Day 2 post surgery)
  • Change in Heamatocrit concentration post surgery(Day 2 post surgery)
  • Mortality(At any time point to 1 year post op)
  • Analgesia Use(5 days)
  • Timed up and go test(6 weeks, 6 months, 1 year)
  • Harris Hip score(6 weeks, 6 months, 1 year)
  • Radiographic assessment of fracture healing(6 weeks, 6 months, 1 year)
  • Radiographic assessment of femoral neck shortening(6 months)

研究者

发起方
University Hospital Waterford
申办方类型
Other
责任方
Principal Investigator
主要研究者

May Cleary

PI

University Hospital Waterford

研究点 (1)

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