Other Instability, ShoulderMOONSINCT02075775
MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
An observational study of Other Instability, Shoulder and Dislocations, run by Carolyn M Hettrich at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Other Instability, Shoulder, Dislocations, Subluxations
- How many people
- 1,733 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2012to Dec 2042
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability
Who may be able to join
- This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.
- Anterior, posterior, and inferior instability
- Ages 12-99
- Open and arthroscopic repair
- Revision of a previous shoulder instability repair
- Latarjet/bone augmentation
Who cannot join
- Workers compensation patients
- Prisoners
- Non-English speaker
- Not mentally competent
- Unable/unwilling to return for clinical follow-up
- Arthroplasty patients
- Rotator cuff tears
- Fractures
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109-0328
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Colorado
Boulder, Colorado, 80304
Ohio State University
Columbus, Ohio, 43221
University of Iowa
Iowa City, Iowa, 52242
University of Kentucky
Lexington, Kentucky, 40536
Vanderbilt University
Nashville, Tennessee, 37232-8774
Hospital for Special Surgery
New York, New York, 10021
UCSF Orthopedic Institute
San Francisco, California, 94158
Orthopedic Institute
Sioux Falls, South Dakota, 57105
Washington University
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Other Instability, Shoulder, Dislocations, Subluxations, Recurrent Dislocation of Shoulder Region
- Keywords
- instability
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MOON Shoulder Instability | Patients indicated for Shoulder Instability surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of worse patient outcomes (pain and/or reduced quality of life).
Patients will fill out PRO's after surgery
Measured: 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
Measured: 2 years, 6 years, 10 years and 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startAug 2012
- Primary completion31 Dec 2032 (estimated)
- Study completionDec 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Other Instability, ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,733 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Carolyn M Hettrich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of California, San Francisco, University of Kentucky, Hospital for Special Surgery, New York, University of Colorado, Denver, Ohio State University, Washington University School of Medicine, Orthopedic Institute, Sioux Falls, SD, Vanderbilt University, Brigham and Women's Hospital
- Responsible party
- Sponsor-investigator, Carolyn M Hettrich, University of Iowa
- Investigators
- Carolyn M Hettrich, MD, MPH, Principal investigator, Brigham and Women's HospitalBrian Wolf, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075775
- Sponsor's protocol ID
- 201208835
- Acronym
- MOONSI
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2014
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 36939180Brophy 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 35442106Baron 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
- ClinicalTrials.gov ID
- NCT02075775
- Acronym / sponsor ID
- MOONSI / 201208835
- Conditions
- Other Instability, Shoulder, Dislocations, Subluxations, Recurrent Dislocation of Shoulder Region
- Keywords
- instability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,733 participants (actual)
- Lead sponsor
- Carolyn M HettrichUniversity, hospital or other
- Collaborators
- University of Michigan, University of California, San Francisco, University of Kentucky, Hospital for Special Surgery, New York, University of Colorado, Denver, Ohio State University, Washington University School of Medicine, Orthopedic Institute, Sioux Falls, SD, Vanderbilt University, Brigham and Women's Hospital
- Study start
- Aug 2012 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- Dec 2042 (estimated)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOON Shoulder Instability | – | –Patients indicated for Shoulder Instability surgery |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability
Key inclusion criteria (6 listed)
- This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.
- Anterior, posterior, and inferior instability
- Ages 12-99
- Open and arthroscopic repair
- Revision of a previous shoulder instability repair
Key exclusion criteria (8 listed)
- Workers compensation patients
- Prisoners
- Non-English speaker
- Not mentally competent
- Unable/unwilling to return for clinical follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors of worse patient outcomes (pain and/or reduced quality of life).
Time frame: 2 years, 6 years, 10 years and 20 years
Patients will fill out PRO's after surgery
1 secondary outcome
Predictors for recurrent instability
Time frame: 2 years, 6 years, 10 years and 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 36939180Hettrich 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.
- Derived from this study: PubMed 35442106Brophy 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.
- Derived from this study: PubMed 34019439Baron 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn M Hettrich, MD, MPH principal investigator
Brigham and Women's Hospital
Brian Wolf, MD, MS principal investigator
University of Iowa
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Instability, Shoulder and Dislocations, run by Carolyn M Hettrich at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of worse patient outcomes (pain and/or reduced quality of life). (time frame: 2 years, 6 years, 10 years and 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.