MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,733
- 试验地点
- 11
- 主要终点
- Predictors of worse patient outcomes (pain and/or reduced quality of life).
研究概览
简要总结
This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy.
Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.
详细描述
The objective of this prospective multicenter cohort study of patients undergoing surgery for glenohumeral instability is to identify the outcomes, and more importantly, the previously unknown predictors of sports function, activity level, general health, recurrent instability symptoms, and surgical failures following surgery. Patient information at the time of the surgery (demographics, validated outcome measures), in addition to the physical exam findings, shoulder pathology at the time of surgery, and surgical treatment will be obtained. The validated outcome instruments are American Shoulder and Elbow Surgeons Score, Western Ontario Shoulder Instability, Kerlan Jobe Overhand Athlete Score, Shoulder Activity Score, and RAND-36. Post-operative physical exam data will be obtained at 6 months after surgery. Patient reported outcomes will be repeated at 2, 6, 10, and 20 years post-operatively. Our multivariable analysis will identify which of the many factors related to the injury, intra-operative treatment, postoperative care, physical patient characteristics, and behavioral patient characteristics contribute to recurrence and poor outcome.
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
- 12 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.
- •Inclusion criteria:
- •Anterior, posterior, and inferior instability
- •Ages 12-99
- •Open and arthroscopic repair
- •Revision of a previous shoulder instability repair
- •Latarjet/bone augmentation
排除标准
- •Workers compensation patients
- •Prisoners
- •Non-English speaker
- •Not mentally competent
- •Unable/unwilling to return for clinical follow-up
- •Arthroplasty patients
- •Rotator cuff tears
- •Fractures
研究组 & 干预措施
MOON Shoulder Instability
Patients indicated for Shoulder Instability surgery
结局指标
主要结局
Predictors of worse patient outcomes (pain and/or reduced quality of life).
时间窗: 2 years, 6 years, 10 years and 20 years
Patients will fill out PRO's after surgery
次要结局
- Predictors for recurrent instability(2 years, 6 years, 10 years and 20 years)
研究者
Carolyn M Hettrich
Associate Professor
University of Iowa
