跳至主要内容
临床试验/CTRI/2025/11/097497
CTRI/2025/11/097497尚未招募1 期

Functional and radiological comparison of multilock nail and proximal humerus locking plate in proximal humerus fractures: A randomized study.

Department of Orthopaedics SRM Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年12月4日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
64
试验地点
1

研究概览

简要总结

Proximal humerus fractures are common injuries in adults and their management remains challenging due to variation in fracture patterns and bone quality. Surgical fixation is often preferred to restore shoulder function and prevent long term disability. Two commonly used fixation methods are the Multilock intramedullary nail and the Proximal Humerus Locking Plate. Previous studies have shown differing results regarding functional recovery, radiological healing, and complication rates between these two implants. The Multilock nail represents the latest generation of intramedullary devices with improved biomechanics and reduced soft tissue damage.

This prospective randomized comparative study aims to evaluate and compare the functional and radiological outcomes of Multilock nail fixation versus Proximal Humerus Locking Plate fixation in patients with proximal humerus fractures. A total of sixty four patients will be included and randomized into two groups. Functional outcome will be assessed using Visual Analog Score, ASES score, and QuickDASH score. Radiological outcomes will include time to union and changes in neck shaft angle. Complications such as infection, implant failure, malunion, and shoulder stiffness will also be recorded.

The study will help determine which surgical method provides better clinical outcomes and may guide surgeons in selecting the appropriate fixation method for proximal humerus fractures.

I

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years.
  • 65 YRS 2)NEER 2, 3, 4 part Proximal Humerus Fracture 3)Normal pre-injury shoulder function.

排除标准

  • Head split fractures, fracture dislocation 2)Neurovascular injury(Brachial plexus injury -flail arm) 3)Chronic shoulder pain or prior surgery 4)Systemic infections 5)Poorly controlled hypertension or diabetes 6)Pathological fracture.

研究者

发起方
Department of Orthopaedics SRM Medical College Hospital and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sathyanand V

SRM Medical College Hospital and Research Centre

研究点 (1)

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