跳至主要内容
临床试验/NCT02075775
NCT02075775进行中(未招募)不适用

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Carolyn M Hettrich11 个研究点 分布在 1 个国家目标入组 1,733 人开始时间: 2012年8月1日最近更新:
适应症

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

发起方
Carolyn M Hettrich
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carolyn M Hettrich

Associate Professor

University of Iowa

研究点 (11)

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