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临床试验/NCT05081453
NCT05081453招募中不适用

Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia

Joaquín Moya-Angeler Pérez-Mateos2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
measurement of the angle of the trochlear groove

研究概览

简要总结

Title

Early identification and treatment of developmental trochlear femoral dysplasia.

Objectives

To identify developmental trochlear femoral dysplasia (DTFD) in the newborn early after birth by ultrasound and evaluate the effect of its treatment with a modificed Pavlik harness.

Study design

Randomized triple-blind clinical trial.

Study population

Newborns with risk factors for the development of DTFD.

Treatment of subjects

Treatment using a modified Pavlik harness currently used for the treatment of developmental dysplasia of the hip (CDD) over a period of two months.

Variables analyzed

Trochlear groove angles measured by ultrasound before and after the intervention in the treatment group and control group.

Follow-up

Two weeks, eight weeks and six months.

Statistic analysis

Student's t test will be used for related samples to compare and analyze the results of each group at the beginning and after the treatment (intervention group) or follow-up (control group). Study will be triple blinded.

详细描述

Joint dysplasias consist of alterations in the normal development of a joint. In these cases, the formation of the normally congruent joint surfaces is altered, producing functional abnormalities that, depending on the degree of dysplasia, can lead to a spectrum of clinical manifestations ranging from complete dislocation, subluxations, severe instabilities, and ultimately early osteoarthritis.

The most studied joint dysplasia is developmental dysplasia of the hip (CDD) where the head of the femur and the acetabulum present different degrees of malformation, giving rise to a non-congruent joint. The clinical spectrum of manifestations of this pathology varies from a complete dislocation to milder forms of dysplasia that can manifest in childhood, youth or adulthood as early osteoarthritis, sometimes requiring multiple interventions for its treatment.

Early detection methods for CDD include: the identification of prenatal risk factors (intrauterine position, family history, first-born…), exploration through specific maneuvers, and confirmation by imaging tests such as ultrasound at birth. The early treatment of CDD consists of the application of a Pavlik harness whose purpose is to keep the newborn in a full-time position (frog position) in which the head of the femur remains completely congruent with the acetabulum, allowing the dysplasia to be reversed in early ages. Thanks to these early detection methods and its early treatment (with minimal adverse effects), many of these clinical alterations that previously went unnoticed have been prevented, and whose late treatment involves surgeries with a degree of invasiveness inversely related to the time of detection of DDC.

The knee is another joint susceptible to developing dysplasia. The most frequent dysplasia of the knee joint involves the femoropatellar joint (FP) formed by the patella and the femoral trochlea. Its normal function is vital to be able to flex and extend the leg since the patella acts as a lever arm increasing the strength of the quadriceps. Therefore, it is a joint subjected to high tensile forces.

In the normal knee in extension, the concave patella is located in the most proximal part of the femur without having any contact with the convex femoral trochlea. As the knee is bent, the patella runs into the deep femoral groove (normal groove angle 135º), which acts as containment and allows it to slide distally as the knee is bent further. It is in these knee flexion positions, more than 90º, where there exist more tensional forces between both articular surfaces.

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 (Care Provider, Investigator, Outcomes Assessor)

盲法说明

triple blind

入排标准

年龄范围
0 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy term and preterm newborns > 35 weeks
  • Breech presentation at birth.

排除标准

  • Infant cerebral palsy,
  • Developmental disorders
  • Chromosomal diseases.

研究组 & 干预措施

Control group without intervention

No Intervention

Control group without intervention. An ultrasound control is performed at 2 and 6 months

Pavlik harness treatment group

Experimental

Application of a pavlik harness for 2 months in position seeking 90º of flexion of both knees and 45º of hip flexion with some abduction. An ultrasound control is performed at 2 and 6 months

干预措施: pavlik harness (Device)

结局指标

主要结局

measurement of the angle of the trochlear groove

时间窗: 20 minutes

It is performed with ultrasound on the subject's knee. It is carried out by orienting the axis of the leg with the transverse probe. The image is focused on the ossified nucleus of the distal femur and oriented so that both non-ossified femoral condyles are visible. The measurement of the angle of the trochlear groove is taken from the nadir of the trochlea along the lines of best fit of the medial and lateral walls of the trochlea.

次要结局

  • patellar height(15 minutes)

研究者

发起方
Joaquín Moya-Angeler Pérez-Mateos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joaquín Moya-Angeler Pérez-Mateos

Principal Investigator

Hospital Universitario Virgen de la Arrixaca

研究点 (2)

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