Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Device Performance and Benefits assessed through improvements in shoulder function
研究概览
简要总结
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
详细描述
Patient-reported outcomes data have been collected among patients undergoing shoulder labrum repair with SureLock all-suture anchors from January 2014 to June 30, 2020. These patients have completed clinical and quality-of-life outcome instruments pre-operatively, and have been stored securely in the OBERD database. Pre-op scores will be compared to post-op scores and analyzed using a one-way ANOVA test with a post-hoc Scheffe procedure.
Patient identifying information will be removed and de-identified codes will be used. Any new prospective data gathered prospectively for the purposes of this study will be entered and stored securely as above.
Data collection forms will consist of the following Patient-Reported Outcome Surveys: WOSI Index, ASES Shoulder Score, and the SF-12.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 to 45 years of age
- •Surgery performed between 1/1/14-12/31/2021
- •Recurrent shoulder instability resulting from an isolated anterior and/or posterior glenoid labral tear
- •Completed pre-operative data (WOSI, ASES, SF-12)
排除标准
- •Diagnosis of concomitant SLAP tear
- •Diagnosis of concomitant full-thickness rotator cuff tear
- •Greater than 10% loss of glenoid bone
- •Greater than 25% humeral head defect
- •Prior surgical intervention for the treatment of shoulder instability (in either the affected shoulder or the contralateral shoulder)
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Device Performance and Benefits assessed through improvements in shoulder function
时间窗: Out to 1 year post-op
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the American Shoulder and Elbow Surgeon Score(ASES) outcome measure. The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
次要结局
- Device Benefits assessed through improvements of health-related quality of life.(Out to 1 year post-op)
- Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events.(Out to 1 year post-op)