跳至主要内容
临床试验/CTRI/2023/09/057253
CTRI/2023/09/057253尚未招募Phase 3 4

Randomized control trial on management of early avascular necrosis of femoral head by core decompression with bisphosphonate therapy versus core decompression

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年10月9日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
At the end of study , their might be probable improvement in Patients managed with Core decompression with bisphosphonate therapy for the treatment of early AVN of the femoral head when compared to management with core decompression only

研究概览

简要总结

Patients coming to OPD with Pain over hip joint will be subjected to history  and clinical examination . on suspicion ofAvascular Necrosis of Femoral Head(AVNFH) radiological assessment of pelvis withX-ray and MRI will be carried out. After proper staging of AVNFH , stage I andII cases will be explained the disease and nature of treatment . on written informedconsent they will be allocated to one group by simple randomization 1,3,5,7,….. to core decompression with bisphosphonate therapy and 2,4,6, …. To coredecompression alone . Patients were also grouped based on their etiologicalfactors causing AVN. Patients will then be subjected to routineblood investigations and fitness for surgery was obtained while doing coredecompression .

A). Clinical data obtained from the patient was noted in a pre-printedforms based on

following parameters like Age, Sex, risk factors, duration of the illnessand physical

assessments (Pain –VAS score, Range of Motion  and deformity) and Harris Hip score.

B). Radiological Data was obtained at the time of first presentation:

  • X-ray AP pelvis with Both hip and Lateral view of affected hip

  • MRI pelvis with both hip along with FICAT-ARLET classification

C). Laboratory Data:-Inflammatory parameters-ESR, CRP,

Coagulation Profile - APTT, PT-INR, BT, CT, CBC, Prothrombin time, platelet count

Others- LFT, KFT

Thereafter patients were posted for surgical intervention and treatmentas per protocol

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • •Skeletally mature patients
  • •Cases of Avascular Necrosis of femoral head in stage 1 and stage 2 of any etiology
  • •Cases willing to undergo surgery for inclusion in one / both hips .

排除标准

  • •Previously operated hips
  • •Cases having arthritic changes in involved hip
  • •Cases unwilling for surgery.

结局指标

主要结局

At the end of study , their might be probable improvement in Patients managed with Core decompression with bisphosphonate therapy for the treatment of early AVN of the femoral head when compared to management with core decompression only

时间窗: 3 weeks , 6 weeks , 3 months , 6 months , 9 months , 12 months

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college

研究点 (1)

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