Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02075775 |
Other study ID # |
201208835 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 2012 |
Est. completion date |
December 2042 |
Study information
Verified date |
November 2022 |
Source |
University of Iowa |
Contact |
Shannon F Ortiz, MPH |
Phone |
319-467-8316 |
Email |
shannon-ortiz[@]uiowa.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
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.
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.