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