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Active, not recruitingNCT02075775MOONSIUpdated Apr 8, 2026

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

An observational study in Other Instability, Shoulder, Dislocations and Subluxations, sponsored by Carolyn M Hettrich. Active, not recruiting at 11 sites in United States. Open to participants aged 12 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Carolyn M Hettrich · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,733
Ages
12 Years to 99 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Other Instability, Shoulder
  • Dislocations
  • Subluxations
  • Recurrent Dislocation of Shoulder Region

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Keywords

  • instability
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In context

Joint Dislocations

98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.

This study's enrollment of 1,733 is above the median of 100 across 37 observational studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

This is the only study on the registry with Carolyn M Hettrich as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,733 participants (actual)
Target follow-up
20 Years
Patient registry
Yes

Groups and cohorts

  • MOON Shoulder Instability

    Patients indicated for Shoulder Instability surgery

06

What researchers measure

Primary outcomes

  1. Predictors of worse patient outcomes (pain and/or reduced quality of life).

    Patients will fill out PRO's after surgery

    Time frame: 2 years, 6 years, 10 years and 20 years

Secondary outcomes

  1. Predictors for recurrent instability

    Patients will be asked if they have had repeat surgery, recurrent dislocation, subluxation, as well as symptoms of instability on WOSI

    Time frame: 2 years, 6 years, 10 years and 20 years

Other outcomes

  1. Predictors of shoulder osteoarthritis

    Patients will fill out PRO's, symptomatic may return for xrays

    Time frame: 6 years, 10 years and 20 years

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Study locations

11 sites
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References and documents

Publications

  • Hettrich CM, Magnuson JA, Baumgarten KM, Brophy RH, Kattan M; MOON Shoulder Group; Bishop JY, Bollier MJ, Bravman JT, Cvetanovich GL, Dunn WR, Feeley BT, Frank RM, Kuhn JE, Lansdown DA, Benjamin Ma C, Marx RG, McCarty EC, Neviaser AS, Ortiz SF, Seidl AJ, Smith MV, Wright RW, Zhang AL, Cronin KJ, Wolf BR. Predictors of Bone Loss in Anterior Glenohumeral Instability. Am J Sports Med. 2023 Apr;51(5):1286-1294. doi: 10.1177/03635465231160286. Epub 2023 Mar 20. PubMed 36939180 ↗
  • 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. PubMed 35442106 ↗
  • 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. PubMed 34019439 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02075775
Lead sponsor
Carolyn M Hettrich
Responsible party
Carolyn M Hettrich (Associate Professor, University of Iowa) — Sponsor-investigator
First posted
Mar 3, 2014
Start date
Aug 2012
Primary completion
Dec 31, 2032 (estimated)
Completion
Dec 2042 (estimated)
Last update
Apr 8, 2026

Study contacts

Carolyn M Hettrich, MD, MPH
principal investigator · Brigham and Women's Hospital
Brian Wolf, MD, MS
principal investigator · University of Iowa

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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