跳至主要内容
临床试验/CTRI/2020/12/030036
CTRI/2020/12/030036尚未招募不适用

To study the effect of early versus late weight bearing after osteosynthesis of proximal tibiafractures.

Post Graduate Institute of Medical Education and Research PGIMER Chandigarh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To identify difference in gait patterns among

研究概览

简要总结

Proximal tibia fractures are one of the commonest bony injuries associated with post- traumatic osteoarthritis. Past few decades have witnessed advances in imaging modalities, surgical concepts, planning and biomechanically better implants, and so is the shift in the post-operative rehabilitation protocols, from late to early-weight bearing. While latest studies indicate no difference between the two regimens, the objectivity in the final functional outcome is still elusive.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Skeletally mature, closed, intra-articular tibia plateau fracture without distal neurovascular deficit.

排除标准

  • Intra-articular fracture not requiring osteosynthesis,
  • Intra-articular eminence fracture,
  • Open fractures,
  • Associated other lower limb fracture,
  • Foot deformities,
  • Limb length discrepancy >2cm,
  • Pathological fracture,
  • Skeletally immature patient, 9 Neurological injury,
  • Vascular injury,
  • Late presentation after >3weeks,
  • Previous surgery of the knee,
  • Previous septic episode,
  • Post-traumatic deformity,
  • Inflammatory arthritis,
  • Pre-existing degenerative Osteoarthritis,
  • Neuromuscular disorder involving either of lower limb.

结局指标

主要结局

To identify difference in gait patterns among

时间窗: Clinical and radiological assessment at 15th day, 30th day, 45th day, 60th day, 3 month and 6 month post-operatively. Gait and biomarker analysis at 6 months post-operatively.

patients with early weight bearing protocol and

时间窗: Clinical and radiological assessment at 15th day, 30th day, 45th day, 60th day, 3 month and 6 month post-operatively. Gait and biomarker analysis at 6 months post-operatively.

late weight bearing protocol by measuring lower

时间窗: Clinical and radiological assessment at 15th day, 30th day, 45th day, 60th day, 3 month and 6 month post-operatively. Gait and biomarker analysis at 6 months post-operatively.

limb symmetry indices after osteosynthesis of

时间窗: Clinical and radiological assessment at 15th day, 30th day, 45th day, 60th day, 3 month and 6 month post-operatively. Gait and biomarker analysis at 6 months post-operatively.

proximal tibia fractures.

时间窗: Clinical and radiological assessment at 15th day, 30th day, 45th day, 60th day, 3 month and 6 month post-operatively. Gait and biomarker analysis at 6 months post-operatively.

次要结局

  • To study the difference between early and late(weight bearing protocol after osteosynthesis of)

研究者

发起方
Post Graduate Institute of Medical Education and Research PGIMER Chandigarh
申办方类型
Research institution and hospital

研究点 (1)

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