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临床试验/CTRI/2025/03/082048
CTRI/2025/03/082048尚未招募4 期

J-Nailing vs Plate Osteosynthesis for proximal Humerus fractures in the elderly - An interventional study

SRM Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Constant Murley Score:

研究概览

简要总结

This prospective randomized controlled trial will be conducted at the Department of Orthopaedics, SRMCH&RC. The study will include patients over the age of 60 years with closed unstable proximal humeral fractures, classified as 2-Part, 3-Part, or 4-Part according to Neer’s Classification. Patients are excluded if they present with neurovascular deficits or if they have fractures with additional complicating factors. A total of 60 patients will be included in the study, with 30 patients randomly assigned to Group A (J nailing) and 30 patients to Group B (PHILOS plating). Demographic data, including age, gender and comorbidities will be collected, and both groups will be monitored for functional outcomes using the Constant-Murley Score at baseline and at 24 months post-surgery as the primary Outcome. Secondary outcomes include VAS score, radiological assessment like time to union and complications. Other parameters, such as duration of surgery and intraoperative blood loss, will also be recorded. The Chi-square test, Z-test, and p-values will be used for statistical analysis.

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
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Elderly aged above 60 years, Closed unstable proximal humerus fractures (2 part, 3 part, 4 part according to Neers classification), Presenting within 4 weeks of injury No neurovascular deficit.

排除标准

  • Compound fractures, Pathological fractures, Patients with fracture dislocation, Polytrauma patients, Patients with previous history of shoulder fracture and shoulder surgery.

结局指标

主要结局

Constant Murley Score:

时间窗: 1 month, 6 months, 1 year

Pain score, shoulder function - movements : Abduction, Flexion, external rotation and internal rotation, activities of daily loving affected and strength

时间窗: 1 month, 6 months, 1 year

次要结局

  • VAS score system for pain(Radiological assessment for healing, callus formation and union time)

研究者

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

Dr Abraham Aleyas

SRM Institute of Science and Technology

研究点 (1)

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