NCT06002009招募中不适用
SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Assess suprascapular nerve funaction
研究概览
简要总结
The primary objective of the study is to determine in adult patients with a rotator cuff tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular nerve.
The secondary objectives are
- To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired.
- To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged.
- To determine factors that are protective against SSN injury.
- Can the patient data gathered be used to optimise operative procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age ≥18 years presenting to a UHNM shoulder clinic with a confirmed diagnosis of a rotator cuff tear (affecting one or both shoulders).
排除标准
- •Bony pathology (such as significant shoulder arthritis that would exclude isolated rotator cuff repair)
- •Grossly abnormal shoulder anatomy
- •Motor Neurone Disease
- •Cervical cord disease affecting the SSN nerve roots
- •Patients unable to undergo MRI scan
- •Previous surgery at the affected glenohumeral joint
- •Patients unable to tolerate NCS
- •Acute fracture affecting the glenohumeral joint
- •Recent glenohumeral joint dislocation (past 12 months)
- •Patients unable or unwilling to give full informed consent
- •Patients unable or unwilling to comply with the study procedures
结局指标
主要结局
Assess suprascapular nerve funaction
时间窗: 36 months
MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.
次要结局
- Nerve recovery(24 months)
- Shoulder scores(36 months)
- Nerve conduction studies(12 months)
- Machine learning(24 months)
研究者
研究点 (1)
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