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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 12 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Workers compensation patients
  • Prisoners
  • Non-English speaker
  • Not mentally competent
  • Unable/unwilling to return for clinical follow-up
  • Arthroplasty patients
  • Rotator cuff tears
  • Fractures

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
MOON Shoulder Instability Patients indicated for Shoulder Instability surgery

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Cale A Jacobs, PhD
859-323-5533
cale.jacobs@uky.edu

More Details

NCT ID
NCT02075775
Status
Recruiting
Sponsor
Carolyn M Hettrich

Study Contact

Shannon F Ortiz, MPH
319-467-8316
shannon-ortiz@uiowa.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.