Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02075775
Study type Observational [Patient Registry]
Source University of Iowa
Contact Shannon F Ortiz, MPH
Phone 319-467-8316
Email shannon-ortiz@uiowa.edu
Status Recruiting
Phase
Start date August 2012
Completion date December 2042

See also
  Status Clinical Trial Phase
Completed NCT03506958 - Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
Completed NCT00137085 - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation N/A
Not yet recruiting NCT02828566 - Intranasal Ketamine for Procedural Sedation Phase 3
Completed NCT03875014 - Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Dual Mobility Cup
Active, not recruiting NCT02529267 - Prospective Abuse and Intimate Partner Violence Surgical Evaluation
Terminated NCT00356837 - Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department N/A
Completed NCT03573765 - Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data