Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeon (ASES) Score at baseline
研究概览
简要总结
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
详细描述
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
This is a prospective longitudinal cohort study to investigate cartilage strain and labral injury utilizing advance MRI techniques. Patients with shoulder instability will be studied at baseline (after injury and prior to surgical treatment) with glenohumeral cartilage strain MRI protocol, pre and post exercise. Patient reported outcomes including Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Surgeon (ASES) Score, and PROMIS physical function and pain scores, will also be evaluated.
Data from this study will be compared to a previous study involving healthy controls that underwent the same exercises and imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years old and ≤ 50 years old
- •Acute injury involving anterior (front) shoulder dislocation
- •Willingness to undergo arthroscopic shoulder stabilization
- •Willingness to participant in standard rehabilitation
排除标准
- •Moderate to severe osteoarthritis prior to surgery
- •Will undergo bony augmentation to glenoid or humerus in addition to shoulder stabilization
- •Unable to undergo standard pre and post-injury/operative rehabilitation
- •History of inflammatory arthritis
- •Previous surgery of the injured shoulder
结局指标
主要结局
American Shoulder and Elbow Surgeon (ASES) Score at baseline
时间窗: Baseline
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes.
Cartilage Strain at baseline at six months post-surgery
时间窗: 6 months post-surgery
Cartilage strain will be assessed using images from MRIs.
Western Ontario Shoulder Instability Index (WOSI) at baseline
时间窗: Baseline
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life).
American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery
时间窗: 6 months post-surgery
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes.
Cartilage Strain at baseline
时间窗: Baseline
Cartilage strain will be assessed using images from MRIs.
Single Assessment Numeric Evaluation (SANE) Scores at baseline
时间窗: Baseline
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function.
Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery
时间窗: 6 months post-surgery
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life).
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery
时间窗: 6 months post-surgery
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
SANE Scores at six months post-surgery
时间窗: 6 months post-surgery
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function.
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline
时间窗: Baseline
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
次要结局
- Correlation of labral injury and glenohumeral cartilage strain(Baseline & six months post-surgery)
- Change in cartilage strain and labrum following surgery(Six months post-surgery)