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临床试验/CTRI/2020/02/023560
CTRI/2020/02/023560尚未招募4 期

Comparison of One Point Fixation And Two Point Fixation For Treatment Of Unilateral Zygomaticomaxillary complex fracture -A Randomized Controlled Trial

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年1月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
46
试验地点
1
主要终点
Surgical outcomes (Operating time, Postoperative pain using visual analog scale (1-10) and swelling measured using measuring tape-Schultze Mosgau et al-

研究概览

简要总结

This is randomized controlled trial of unilateral zygomaticomaxillary complex fracture which compares one point fixation with two point fixation in terms of surgical and radiographic outcomes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Patients having Unilateral ZMC fracture.
  • Patient Aged more than 18 years and all genders Patients ready to give written informed consent.

排除标准

  • Patients with Severely comminuted ZMC fracture Patients having Orbital floor fracture associated with ZMC fracture Pregnant patients.

结局指标

主要结局

Surgical outcomes (Operating time, Postoperative pain using visual analog scale (1-10) and swelling measured using measuring tape-Schultze Mosgau et al-

时间窗: First postoperative day, seventh postopeartive day.

s1: from tragus of ear to corner of mouth

时间窗: First postoperative day, seventh postopeartive day.

one-point and two-point fixation of unilateral zygomaticomaxillary complex

时间窗: First postoperative day, seventh postopeartive day.

s2: from tragus of ear to soft tissue pogonion.

时间窗: First postoperative day, seventh postopeartive day.

s3: from lateral canthus of eye to angle of mandible) after

时间窗: First postoperative day, seventh postopeartive day.

fracture.

时间窗: First postoperative day, seventh postopeartive day.

次要结局

  • Radiographic changes and Post-operative sequalae (Wound dehiscence,(Infection, Plate palpability, Paresthesia, Scar) after one-point and two-point)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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