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临床试验/CTRI/2025/03/082864
CTRI/2025/03/082864尚未招募3 期

Comparison of radiological and functional outcome of paediatric non traumatic femoral head osteonecrosis managed by core decompression alone versus core decompression and bone marrow concentrate aspirate- a prospective pseudo-randomized study.

Internal - Fluid Research Grant1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Paediatric Outcomes Data Collection Instrument (PODCI).

研究概览

简要总结

Femoral head osteonecrosis (FHO) is a condition where the disruption of blood supply to the femoral head leads to bone death and collapse. It can result in pain, stiffness, and disability in children and adolescents. The etiology of FHO in children is diverse and includes trauma, infection, sickle cell disease, steroid use, and idiopathic factors. The treatment of FHO in children aims to preserve the femoral head shape and function and prevent or delay the need for hip replacement. One of the common surgical treatments for FHO in children is core decompression, which involves drilling a hole into the femoral head to relieve pressure and improve blood flow. Core decompression can be combined with other techniques, such as bone grafting, bone morphogenetic protein, or bone marrow concentrate aspirate (BMCA).

Non traumatic FHO- due to various etiology including SCD, other haematological conditions and children on steroid treatment, will be included in the study, only after being diagnosed to have FHO by MRI.

The FHO in these children will be classified as per Steinberg classification which indicates severity of the disease process. Among these children only those femoral heads in the pre collapse stage (Stage I-III) will be included in the study.

 Despite the difference in etiology and the disease specific challenges, since the disease pathology (FHO) is staged as per Steinberg I-III, the baseline status of osteonecrosis as per inclusion criteria is limited to pre collapse stage of FHO.

But, in some disease conditions, children who undergo intervention in our study may still continue their medical treatment, like steroids and potentially have an effect on the conclusions in our study.

Paediatric population diagnosed to have femoral head osteonecrosis by MRI will be included in the study. They will be screened by the applying inclusion criteria and allotted by consecutive sampling into Group A and Group B, after obtaining consent. In Group A, after pre anesthetic clearance, core decompression of the femoral head will be performed, whereas in Group B, patients will undergo core decompression of the femoral head followed by application of bone marrow aspirate concentrate obtained from the ipsilateral iliac crest. Patients in both groups will have evaluation of the functional parameters, using the quality of life, clinical scoring and radiographic parameters in the pre-operative, six months, one- and two-year postoperative periods. The demographic and anthropometric parameters and complications also will be recorded.

These parameters will be compared for the Group A and Group B patients, and the result obtained will be used to infer about the safety, efficacy and advantages of the interventions.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of Nontraumatic Femoral head osteonecrosis (FHO) by history, clinical examination, and MRI Stage I to stage III osteonecrosis according to Steinberg classification Willingness to participate and provide informed consent.

排除标准

  • FHO secondary to trauma, Perthes disease, Developmental Dysplasia of Hip Previous surgery or conservative treatment for FHO Contraindications to Core Decompression (CD) or Bone Marrow Aspirate Concentrate (BMAC), such as infection, malignancy, or allergy.

结局指标

主要结局

Paediatric Outcomes Data Collection Instrument (PODCI).

时间窗: at pre-operative, postoperative six months, one year and two years.

次要结局

  • 1. To evaluate the radiographic parameters, such as femoral head sphericity, caput index, joint space width, and osteonecrosis Steinberg stage.(2. Complications, such as infection, fracture, and avascular necrosis progression.)

研究者

发起方
Internal - Fluid Research Grant
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rasim Abid Elayedatt

Christian Medical College Vellore

研究点 (1)

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