Clinical trial NCT02075775: MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Official title: MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Other Instability, Shoulder
Dislocations
Subluxations
Recurrent Dislocation of Shoulder Region
Keywords: instability
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of California, San Francisco
name: University of Kentucky
name: Hospital for Special Surgery, New York
name: University of Colorado, Denver
name: Ohio State University
name: Washington University School of Medicine
name: Orthopedic Institute, Sioux Falls, SD
name: Vanderbilt University
name: Brigham and Women's Hospital
First posted: 2014-03-03
Enrollment: 2500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictors of worse patient outcomes (pain and/or reduced quality of life).
timeFrame: 2 years, 6 years, 10 years and 20 years
Secondary outcomes:
measure: Predictors for recurrent instability
timeFrame: 2 years, 6 years, 10 years and 20 years
Other outcomes:
measure: Predictors of shoulder osteoarthritis
timeFrame: 6 years, 10 years and 20 years
Locations:
city: San Francisco
country: United States
facility: UCSF Orthopedic Institute
state: California
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Sioux Falls
country: United States
facility: Orthopedic Institute
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Brigham and Women's Hospital
name: Carolyn M Hettrich, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Brian Wolf, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brophy RH, Dunn WR; MOON Shoulder Group; Baumgarten KM, Bishop JY, Bollier MJ, Bravman JT, Feeley BT, Grant JA, Jones GL, Kuhn JE, Benjamin Ma C, Marx RG, McCarty EC, Ortiz SF, Smith MV, Wolf BR, Wright RW, Zhang AL, Hettrich CM. Factors Associated With Shoulder Activity Level at Time of Surgery and at 2-Year Follow-up in Patients Undergoing Shoulder Stabilization Surgery. Am J Sports Med. 2022 May;50(6):1503-1511. doi: 10.1177/03635465221085978. Epub 2022 Apr 20.
citation: Baron JE, Duchman KR, Hettrich CM, Glass NA, Ortiz SF; MOON Shoulder Group; Baumgarten KM, Bishop JY, Bollier MJ, Bravman JT, Brophy RH, Carpenter JE, Cox CL, Feeley BT, Frank RM, Grant JA, Jones GL, Kuhn JE, Lansdown DA, Benjamin Ma C, Marx RG, McCarty EC, Miller BS, Neviaser AS, Seidl AJ, Smith MV, Wright RW, Zhang AL, Wolf BR. Beach Chair Versus Lateral Decubitus Position: Differences in Suture Anchor Position and Number During Arthroscopic Anterior Shoulder Stabilization. Am J Sports Med. 2021 Jul;49(8):2020-2026. doi: 10.1177/03635465211013709. Epub 2021 May 21.