跳至主要内容
临床试验/NCT04086368
NCT04086368招募中不适用

Derotational Femoral Osteotomy With Either Percutaneous Osteotomy and Intramedullary Nailing or Open Approach and Plating - a Randomized Controlled Trail

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
2
主要终点
Accuracy of the derotation

研究概览

简要总结

Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. There is no clear evidence in the literature supporting which surgical technique or implant that should be used. Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described and has shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.

The primary objective of this project, is to investigate if derotational osteotomy by means of percutaneous osteotomy and nailing is a safe and accurate method compared to an open approach and plating.

详细描述

Introduction:

Gait deviations in children may be caused by excessive femoral anteversion (AV). This rotational deformity is usually self-limiting but is a common cause of parental concern. Femoral anteversion is an inward twisting (rotation) of the femur. Excessive femoral anteversion causes the patients knees and feet to turn inwards and have a "pigeon-toed" appearance. The AV angle can be measured in the transverse plane by a line through the centre of the femoral head and neck and a tangential line across of the posterior femoral condyles. In the majority of cases of increased femoral AV, normalization occurs spontaneously during growth.

Persisting excessive femoral torsion after the age of 8 years may lead to tripping and anterior hip and knee pain. Recent studies have shown that increased internal rotation is a risk factor for patellofemoral instability and may result in patellofemoral contact pressure.

There are no studies supporting conservative treatment with physiotherapy or braces. Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. Several techniques have been described and there is no clear evidence in the literature supporting which surgical technique or implant that should be used (3). Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described both for rotational osteotomies and femoral fractures. With a lateral trochanteric entry point this has been shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.

Study aims:

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

Single (Outcomes Assessor)

入排标准

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

入选标准

  • Radiographic findings: Femoral AV angle ≥ 30°
  • Age 10-18 years.
  • Hip or/and knee pain
  • Less than 15 degrees external rotation of the hips

排除标准

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Previous femoral injury or illness which reduces the function of the extremity
  • Systemic or chronic injury or illness which reduces the function of the extremity
  • If the patient is not able to comply with study procedures

结局指标

主要结局

Accuracy of the derotation

时间窗: post operative (day1)

Accuracy of the derotation measured in degrees on CT comparing the intended/planned correction with the actual derotation

次要结局

  • Visual analogue scale(Baseline, daily first six week. 4 times a day.)
  • KIDSCREEN-27(Baseline, 26 week, 52 week follow-up)
  • Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child)(Baseline, 26 week and 52 week follow-up)

研究者

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

Anders Grønseth

M.D. Principal Investigator

Oslo University Hospital

研究点 (2)

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