跳至主要内容
临床试验/CTRI/2024/05/067440
CTRI/2024/05/067440尚未招募Phase 3 4

Outcome of metatarsal fractures treated with intramedullary Kirschner wire fixation

JNMC1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月24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
30
试验地点
1
主要终点
To analyze outcome of fractures of metatarsals treated with intramedullary fixation with Kirschner wire

研究概览

简要总结

Patients coming to AVBRH department of Orthopaedics will be examined clinically and radiographic evaluationof foot Antero-posterior and oblique will be done. The patients diagnosed with having metatarsal fracture will be selected. Based on the inclusion and exclusion criteria, the selected patients for the study will be subjected to a proforma. Consents will be obtained from the selected study subjects. The consenting individuals will then be investigated based on routine investigations like CBC, KFT, LFT, RBS and PT-INR. Once the routine investivagtions are within normal range, the patients will either be managed with single or two k-wires fixation for metatarsal fracture. Closed or open reduction and K-wire fixation will be carried out in patients consenting for the study. Randomization will be utilized when sampling the patients. The patients will then be followed up at 3 days, 2 weeks, 6 weeks, 3 months and 6 months to evaluate the functional outcomes using FAAM and American orthopedic foot and ankle score and radiological outcomes.

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
15.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • Single or Multiple metatarsal fractures 2) Open or closed fractures.

排除标准

  • Pathological fractures 2)Avulsion fractures 3)Stress fractures 4)Patients having pre-existing ipsilateral ankle, foot, knee and hip conditions.

结局指标

主要结局

To analyze outcome of fractures of metatarsals treated with intramedullary fixation with Kirschner wire

时间窗: AT 3 days, | AT 2 weeks, | AT 1 ½ month, | AT 3 month, | AT 6 months

次要结局

  • The secondary outcomes of the study includes analysis of fractures of Metatarsals in terms of(1) Radiological outcome)

研究者

发起方
JNMC
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vatsal Patel

Datta Meghe Institute of higher education and research

研究点 (1)

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