Instability, JointOREFNCT05431114
Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability
An observational study of Instability, Joint and Shoulder Dislocation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Instability, Joint, Shoulder Dislocation, Shoulder Injuries
- What is being tested?
- MRI
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of individuals ages 18 to 50 years old, who have sustained an anterior shoulder dislocation that requires surgical intervention.
Who may be able to join
- Males and females ≥ 18 years old and ≤ 50 years old
- Acute injury involving anterior (front) shoulder dislocation
- Willingness to undergo arthroscopic shoulder stabilization
- Willingness to participant in standard rehabilitation
Who cannot join
- Moderate to severe osteoarthritis prior to surgery
- Will undergo bony augmentation to glenoid or humerus in addition to shoulder stabilization
- Unable to undergo standard pre and post-injury/operative rehabilitation
- History of inflammatory arthritis
- Previous surgery of the injured shoulder
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sports Science Institute
Durham, North Carolina, 27705
About this study
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
Read the detailed description
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
This is a prospective longitudinal cohort study to investigate cartilage strain and labral injury utilizing advance MRI techniques. Patients with shoulder instability will be studied at baseline (after injury and prior to surgical treatment) with glenohumeral cartilage strain MRI protocol, pre and post exercise. Patient reported outcomes including Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Surgeon (ASES) Score, and PROMIS physical function and pain scores, will also be evaluated.
Data from this study will be compared to a previous study involving healthy controls that underwent the same exercises and imaging.
- Conditions
- Instability, Joint, Shoulder Dislocation, Shoulder Injuries, Shoulder Subluxation, Anterior Shoulder Instability, Glenoid; Dislocation
- Being tested
- MRI
- Keywords
- Instability, Shoulder, Dislocation, Glenoid, Acute, Arthroscopy
- Medical subject headings
- Joint Instability, Shoulder Dislocation, Shoulder Injuries, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Images of the injured shoulder will then be taken with magnetic resonance (MR) scanner. MRIs of each participant's shoulder will be acquired before and after completion of an exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder patients | Participants who presents with glenohumeral instability. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage Strain at baseline
Cartilage strain will be assessed using images from MRIs.
Measured: Baseline
Cartilage Strain at baseline at six months post-surgery
Cartilage strain will be assessed using images from MRIs.
Measured: 6 months post-surgery
Western Ontario Shoulder Instability Index (WOSI) at baseline
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life).
Measured: Baseline
Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life).
Measured: 6 months post-surgery
American Shoulder and Elbow Surgeon (ASES) Score at baseline
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes.
Measured: Baseline
American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes.
Measured: 6 months post-surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Measured: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Measured: 6 months post-surgery
Single Assessment Numeric Evaluation (SANE) Scores at baseline
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function.
Measured: Baseline
SANE Scores at six months post-surgery
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function.
Measured: 6 months post-surgery
Secondary outcomes (2)
Correlation of labral injury and glenohumeral cartilage strain
The relationship between labral injury and glenohumeral cartilage strain and contact areas will be assessed using images from MRIs.
Measured: Baseline & six months post-surgery
Change in cartilage strain and labrum following surgery
The relationship between labral injury and glenohumeral cartilage strain and contact areas will be assessed using images from MRIs from pre and post-surgery.
Measured: Six months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start2 Aug 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instability, JointStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Lau, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431114
- Sponsor's protocol ID
- Pro00110036
- Acronym
- OREF
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability
- ClinicalTrials.gov ID
- NCT05431114
- Acronym / sponsor ID
- OREF / Pro00110036
- Conditions
- Instability, Joint, Shoulder Dislocation, Shoulder Injuries, Shoulder Subluxation, Anterior Shoulder Instability, Glenoid; Dislocation
- Keywords
- Instability, Shoulder, Dislocation, Glenoid, Acute, Arthroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 24 Jun 2022 (actual)
- 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.
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
Detailed description
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
This is a prospective longitudinal cohort study to investigate cartilage strain and labral injury utilizing advance MRI techniques. Patients with shoulder instability will be studied at baseline (after injury and prior to surgical treatment) with glenohumeral cartilage strain MRI protocol, pre and post exercise. Patient reported outcomes including Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Surgeon (ASES) Score, and PROMIS physical function and pain scores, will also be evaluated.
Data from this study will be compared to a previous study involving healthy controls that underwent the same exercises and imaging.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder patients | – | Diagnostic Test: MRIParticipants who presents with glenohumeral instability. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of individuals ages 18 to 50 years old, who have sustained an anterior shoulder dislocation that requires surgical intervention.
Key inclusion criteria (4 listed)
- Males and females ≥ 18 years old and ≤ 50 years old
- Acute injury involving anterior (front) shoulder dislocation
- Willingness to undergo arthroscopic shoulder stabilization
- Willingness to participant in standard rehabilitation
Key exclusion criteria (5 listed)
- Moderate to severe osteoarthritis prior to surgery
- Will undergo bony augmentation to glenoid or humerus in addition to shoulder stabilization
- Unable to undergo standard pre and post-injury/operative rehabilitation
- History of inflammatory arthritis
- Previous surgery of the injured shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIImages of the injured shoulder will then be taken with magnetic resonance (MR) scanner. MRIs of each participant's shoulder will be acquired before and after completion of an exercise protocol. | Diagnostic test | Shoulder patients |
Primary outcome
Cartilage Strain at baseline
Time frame: Baseline
Cartilage strain will be assessed using images from MRIs.
Cartilage Strain at baseline at six months post-surgery
Time frame: 6 months post-surgery
Cartilage strain will be assessed using images from MRIs.
Western Ontario Shoulder Instability Index (WOSI) at baseline
Time frame: Baseline
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life).
Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery
Time frame: 6 months post-surgery
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life).
American Shoulder and Elbow Surgeon (ASES) Score at baseline
Time frame: Baseline
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes.
American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery
Time frame: 6 months post-surgery
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes.
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline
Time frame: Baseline
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery
Time frame: 6 months post-surgery
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Single Assessment Numeric Evaluation (SANE) Scores at baseline
Time frame: Baseline
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function.
SANE Scores at six months post-surgery
Time frame: 6 months post-surgery
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function.
2 secondary outcomes
Correlation of labral injury and glenohumeral cartilage strain
Time frame: Baseline & six months post-surgery
Change in cartilage strain and labrum following surgery
Time frame: Six months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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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.
Brian Lau, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Instability, Joint and Shoulder Dislocation, run by Duke University at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cartilage Strain at baseline (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.