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临床试验/NCT05188391
NCT05188391招募中不适用

A Novel Examination Method for Deltoid Injuries: Deltoid Gap Sign

Goztepe Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Sensitivity of the Gap Sign

研究概览

简要总结

"Deltoid Gap Sign" which would be a new method of examination for deltoid ligament injuries will be investigated. It will be analyzed if it is correlated with the external rotation stress test. The study is designed as a blinded, comparative and prospective trial.

详细描述

Ankle fracture patients who applied to our clinic agreed to be included in the study and underwent surgical intervention will participate in the study. The pediatric age group will not be included in the study, since deltoid ligament tears are not common in ankle fractures in pediatric age. However, since this fracture can also be seen in pregnant women, if there is a pregnant patient who will require surgical treatment, they can be included in the study.

"Deltoid Gap Sign" which is the main subject of this study, will be performed in patients firstly at patients' ward i) without pre-operative anesthesia, secondly at operating theatre ii) under anesthesia before the operation. The examination will be carried out by two different physicians and the opinion of both physicians will be noted. Physicians will be blinded and will not know others' decisions.

External rotation stress test (ERST) in dorsiflexion, which is another examination method accepted in the literature in the evaluation of the deltoid ligament, will also be performed by two physicians and the opinions of the physicians will be noted. ERST will be analyzed under fluoroscopy control.

After the examination, open surgery will be performed around the medial malleolus. It will be noted whether the deltoid ligament was injured (ruptured/ not ruptured), which fibers of the deltoid ligament (superficial/deep/superficial + deep fibers) were ruptured.

Statistical ratios such as positive predictive value, negative predictive value, sensitivity, specificity, and likelihood ratio will be calculated based on the results obtained.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Physicians who will perform the examination will not know other physicians' decisions.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who had operated on because of ankle trauma
  • •Patients who had been performed an open surgery at the medial malleolus region
  • •Patients with Maisonneuve fractures

排除标准

  • •Medial malleolus fractures
  • •Talus fractures
  • •Patients in pediatric age

研究组 & 干预措施

Positive Group (Rupture and Gap Sign are both positive)

Other

Rupture and Gap Sign are both positive

干预措施: Deltoid Gap Sign (Diagnostic Test)

Rupture Positive Group (Rupture positive but Gap Sign is negative)

Other

Rupture positive but Gap Sign is negative

干预措施: Deltoid Gap Sign (Diagnostic Test)

Gap Sign Positive Group (No rupture exists but Gap Sign is positive)

Other

No rupture exists but Gap Sign is positive

干预措施: Deltoid Gap Sign (Diagnostic Test)

Negative Group (Rupture and Gap sign are both negative)

Other

Rupture and Gap sign are both negative

干预措施: Deltoid Gap Sign (Diagnostic Test)

结局指标

主要结局

Sensitivity of the Gap Sign

时间窗: 24 hours

Gap Sign will be recorded either positive or negative after performing Deltoid Gap Sign. During the open surgery, the rupture of the ligament will be evaluated again. Then sensitivity of Gap Sign will be calculated using Chi Square test.

次要结局

  • Specificity of the Gap Sign(24 hours)
  • Likelihood ratios of the Gap Sign(24 hours)

研究者

发起方
Goztepe Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esat UYGUR

Assoc.Prof.M.D.

Goztepe Training and Research Hospital

研究点 (1)

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