Osteoarthritis of the ShoulderUESOANCT04634773
Unravelling the Etiology of Shoulder Osteoarthritis
A study testing Low-dose CT, T1Rho MRI and Motion Analysis in people with Osteoarthritis of the Shoulder, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
Osteoarthritis (OA) is a progressive disease resulting from the degradation of synovial joint articular cartilage over time. The hallmark symptom is diffuse aching and progressive pain made worse with activity. Loss of range of motion and compromised function inevitably follow. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- Low-dose CT, T1Rho MRI and Motion Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Jun 2021to Dec 2027
- Phase
- Interventional
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults <60 years of age
- Posterior humeral head subluxation >55% (determined from imaging)
Who cannot join
- >60 years of age
- History of shoulder instability
- History of shoulder trauma including fracture
- Neurological disorders of the upper limb
- Imaging evidence of humeral head or glenoid bony deformity
- Rotator cuff pathology
- Labral pathology
- Pre-existing joint deformity (OA) cases greater than grade I (as per Samilson and Prieto)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Ottawa
Ottawa, Ontario, K1N 6N5
Carleton University
Ottawa, Ontario, K1S5B6
About this study
Osteoarthritis (OA) is a progressive disease resulting from the degradation of synovial joint articular cartilage over time.
The hallmark symptom is diffuse aching and progressive pain made worse with activity. Loss of range of motion and compromised function inevitably follow. This degenerative disease can affect the shoulder joint. When symptoms become refractory to conservative treatment such as anti-inflammatory medication, steroid injections, activity modification or physical therapy; surgery (total or reverse shoulder arthroplasty) may be considered.
Read more
Idiopathic shoulder OA is typically characterized by posterior subluxation of the humeral head upon the glenoid and posterior bone loss. An imbalance in the application of forces applied to the proximal humerus by the posterior and anterior rotator cuff muscles has been postulated to be the leading cause of idiopathic shoulder OA. However, there is only preliminary evidence to support this theory and the etiology of this pattern of deformity is unknown. The theory the posterior humeral head subluxation is a precursor to OA is only supported by very low-level evidence and no longitudinal studies have been conducted. As a result, the cause and natural history of shoulder OA remains unknown.
Research into this area is urgently needed to generate knowledge that will inform future treatments aimed at modifying and slowing the progression of shoulder OA and to reduce the need for shoulder replacement therapy.
The aim of this project is to develop an understanding of the pathophysiology of shoulder OA.
Read the detailed description
Purpose: The aim of this project is to develop an understanding of the pathophysiology of shoulder OA. This project will recruit two groups of 30 participants, (60 participants in total) and follow them over a period of 5-years.
Group 1- Participants with posterior subluxation of the humeral head and show early signs of degeneration in their shoulder 'disease group' Group 2- Participants with posterior subluxation of the humeral head and show no signs of degeneration 'control/healthy' group
Hypotheses: The investigators hypothesize that there are several factors that contribute to the development of shoulder OA. Uncovering those pathways will lead to more targeted therapy. (1) The posterior rotator cuff muscles (infraspinatus/teres minor) apply relatively greater force than the anterior (subscapularis) cuff; an imbalance in the force couple occurs and the humeral head translates posteriorly on the glenoid; progressive posterior subluxation of the humeral head occurs and degeneration of the glenoid and humeral head cartilage follow. (2) Posterior subluxation of the humeral head is associated with progressive cartilage proteoglycan loss. (3) Pre-morbid glenoid morphology including increased retroversion is associated with the development of shoulder OA.
Participant Involvement: The following will be completed with participants: T1Rho Magnetic Resonance Imaging (MRI), quantitative Computed Tomography (qCT), functional and motion analysis at baseline, year 2 and year 4 in the 'affected' shoulder in both groups 1 and 2. These tests will also be conducted on the asymptomatic, contralateral shoulder in Group 1 participants at baseline and year 4. The finite element model validation will be performed in years 2 and 3, and participant-specific finite element analysis (which has no active participant involvement) will occur in years 3 to 5. Overall study analysis will occur in year 5. This project will be done in two-parts. The first part will consist of six participants; assuming further funding is obtained, part two of the study will proceed. The second part of the project will be based on successfully obtaining funds to continue the remainder of the study recruitment (54 participants) and testing. As pilot data is urgently needed to secure granting funds to support this overall project, the investigators will commence with recruiting the first 6 participants. Once further funds are secured, the remaining portion (recruitment of 54 participants) of the project will continue.
Objectives: (1) Determine whether patients with posterior humeral head subluxation have an imbalance between the posterior and anterior rotator cuff muscles. Objective 1 will be assessed through T1Rho MRI, and functional testing/motion analysis.
(2) Determine whether patients with static posterior subluxation of the humeral head are at risk of degenerative changes (i.e. proteoglycan loss). Objective 2 will be assessed through T1Rho MRI and qCT scans.
(3) Determine which joint factors are associated with progression of OA. This will be assessed using qCT scans and finite element model analysis.
Clinical Relevance: The cause is shoulder OA is unknown, and the burden and costs associated with this degenerative disease are increasing with our aging population. Research in this area is urgently needed to generate knowledge which will inform future treatments which may modify and slow the progression of shoulder OA, and to reduce the need for shoulder replacement therapy.
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- Low-dose CT, T1Rho MRI, Motion Analysis
- Keywords
- T1Rho MRI, qCT, Motion Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CTRadiation
A low-dose, or quantitative (q) CT scan will be performed on the shoulder. This CT scan will be done to assess the bony structure of the shoulder, as well as bone strength, which can influence the health of the cartilage.
Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder.
Group 2 participants will complete this scan at baseline, 2-years and 4-years.
T1Rho MRIOther
A T1Rho MRI will be performed on the shoulder. This imaging technique uses a special sequence and will be used to assess the muscles and tendons around the shoulder.
Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder.
Group 2 participants will complete this scan at baseline, 2-years and 4-years.
Motion AnalysisOther
Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising.
Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder.
Group 2 participants will complete this scan at baseline, 2-years and 4-years.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Early Degeneration ('Disease') | Experimental | Those who have posterior subluxation of the humeral head and show early signs of degeneration in their shoulder. Receives: Radiation: Low-dose CT; Other: T1Rho MRI; Other: Motion Analysis |
| Group 2: No Degeneration ('Healthy') | Active comparator | Those who have posterior subluxation of the humeral head and show no signs of degeneration. Receives: Radiation: Low-dose CT; Other: T1Rho MRI; Other: Motion Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1Rho MRI
MRI will be used to measure the muscle-fat ratio, and tendon thickness. Increased fat-infiltration, and tendon thinning indicates a worse outcome.
Measured: 5-Years Post-Allocation
qCT (Low Dose CT)
Used to measure bone loss and density. Increased bone loss, and decreased density indicate a worse outcome.
Measured: 5-Years Post-Allocation
Motion Analysis
A kinematic evaluation of the shoulder while performing functional tasks will help us determine how the rotator cuff muscle imbalance influences the shoulder joint kinematics.
Measured: 5-Years Post-Allocation
Finite Element Analysis
This will be combined with motion analysis results to gain a better understanding of the internal loading within the tissues of the joint that could explain degenerative changes observed by imaging. Increased stresses, and muscle imbalance result in a worse outcome.
Measured: 5-Years Post-Allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start23 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634773
- Sponsor's protocol ID
- 20200766-01H
- Acronym
- UESOA
- Status last verified
- Jul 2025
- First submitted
- 12 Nov 2020
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling the Etiology of Shoulder Osteoarthritis
- ClinicalTrials.gov ID
- NCT04634773
- Acronym / sponsor ID
- UESOA / 20200766-01H
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- T1Rho MRI, qCT, Motion Analysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Nov 2020 (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.
Osteoarthritis (OA) is a progressive disease resulting from the degradation of synovial joint articular cartilage over time.
The hallmark symptom is diffuse aching and progressive pain made worse with activity. Loss of range of motion and compromised function inevitably follow. This degenerative disease can affect the shoulder joint. When symptoms become refractory to conservative treatment such as anti-inflammatory medication, steroid injections, activity modification or physical therapy; surgery (total or reverse shoulder arthroplasty) may be considered.
Idiopathic shoulder OA is typically characterized by posterior subluxation of the humeral head upon the glenoid and posterior bone loss. An imbalance in the application of forces applied to the proximal humerus by the posterior and anterior rotator cuff muscles has been postulated to be the leading cause of idiopathic shoulder OA. However, there is only preliminary evidence to support this theory and the etiology of this pattern of deformity is unknown. The theory the posterior humeral head subluxation is a precursor to OA is only supported by very low-level evidence and no longitudinal studies have been conducted. As a result, the cause and natural history of shoulder OA remains unknown.
Research into this area is urgently needed to generate knowledge that will inform future treatments aimed at modifying and slowing the progression of shoulder OA and to reduce the need for shoulder replacement therapy.
The aim of this project is to develop an understanding of the pathophysiology of shoulder OA.
Detailed description
Purpose: The aim of this project is to develop an understanding of the pathophysiology of shoulder OA. This project will recruit two groups of 30 participants, (60 participants in total) and follow them over a period of 5-years.
Group 1- Participants with posterior subluxation of the humeral head and show early signs of degeneration in their shoulder 'disease group' Group 2- Participants with posterior subluxation of the humeral head and show no signs of degeneration 'control/healthy' group
Hypotheses: The investigators hypothesize that there are several factors that contribute to the development of shoulder OA. Uncovering those pathways will lead to more targeted therapy. (1) The posterior rotator cuff muscles (infraspinatus/teres minor) apply relatively greater force than the anterior (subscapularis) cuff; an imbalance in the force couple occurs and the humeral head translates posteriorly on the glenoid; progressive posterior subluxation of the humeral head occurs and degeneration of the glenoid and humeral head cartilage follow. (2) Posterior subluxation of the humeral head is associated with progressive cartilage proteoglycan loss. (3) Pre-morbid glenoid morphology including increased retroversion is associated with the development of shoulder OA.
Participant Involvement: The following will be completed with participants: T1Rho Magnetic Resonance Imaging (MRI), quantitative Computed Tomography (qCT), functional and motion analysis at baseline, year 2 and year 4 in the 'affected' shoulder in both groups 1 and 2. These tests will also be conducted on the asymptomatic, contralateral shoulder in Group 1 participants at baseline and year 4. The finite element model validation will be performed in years 2 and 3, and participant-specific finite element analysis (which has no active participant involvement) will occur in years 3 to 5. Overall study analysis will occur in year 5. This project will be done in two-parts. The first part will consist of six participants; assuming further funding is obtained, part two of the study will proceed. The second part of the project will be based on successfully obtaining funds to continue the remainder of the study recruitment (54 participants) and testing. As pilot data is urgently needed to secure granting funds to support this overall project, the investigators will commence with recruiting the first 6 participants. Once further funds are secured, the remaining portion (recruitment of 54 participants) of the project will continue.
Objectives: (1) Determine whether patients with posterior humeral head subluxation have an imbalance between the posterior and anterior rotator cuff muscles. Objective 1 will be assessed through T1Rho MRI, and functional testing/motion analysis.
(2) Determine whether patients with static posterior subluxation of the humeral head are at risk of degenerative changes (i.e. proteoglycan loss). Objective 2 will be assessed through T1Rho MRI and qCT scans.
(3) Determine which joint factors are associated with progression of OA. This will be assessed using qCT scans and finite element model analysis.
Clinical Relevance: The cause is shoulder OA is unknown, and the burden and costs associated with this degenerative disease are increasing with our aging population. Research in this area is urgently needed to generate knowledge which will inform future treatments which may modify and slow the progression of shoulder OA, and to reduce the need for shoulder replacement therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Early Degeneration ('Disease') | Experimental | Radiation: Low-dose CT, Other: T1Rho MRI, Other: Motion AnalysisThose who have posterior subluxation of the humeral head and show early signs of degeneration in their shoulder. |
| Group 2: No Degeneration ('Healthy') | Active comparator | Radiation: Low-dose CT, Other: T1Rho MRI, Other: Motion AnalysisThose who have posterior subluxation of the humeral head and show no signs of degeneration. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults <60 years of age
- Posterior humeral head subluxation >55% (determined from imaging)
Key exclusion criteria (8 listed)
- >60 years of age
- History of shoulder instability
- History of shoulder trauma including fracture
- Neurological disorders of the upper limb
- Imaging evidence of humeral head or glenoid bony deformity
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 |
|---|---|---|
| Low-dose CTA low-dose, or quantitative (q) CT scan will be performed on the shoulder. This CT scan will be done to assess the bony structure of the shoulder, as well as bone strength, which can influence the health of the cartilage. Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder. Group 2 participants will complete this scan at baseline, 2-years and 4-years. | Radiation | Group 1: Early Degeneration ('Disease'), Group 2: No Degeneration ('Healthy') |
| T1Rho MRIA T1Rho MRI will be performed on the shoulder. This imaging technique uses a special sequence and will be used to assess the muscles and tendons around the shoulder. Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder. Group 2 participants will complete this scan at baseline, 2-years and 4-years. | Other | Group 1: Early Degeneration ('Disease'), Group 2: No Degeneration ('Healthy') |
| Motion AnalysisMotion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising. Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder. Group 2 participants will complete this scan at baseline, 2-years and 4-years. | Other | Group 1: Early Degeneration ('Disease'), Group 2: No Degeneration ('Healthy') |
Primary outcome
T1Rho MRI
Time frame: 5-Years Post-Allocation
MRI will be used to measure the muscle-fat ratio, and tendon thickness. Increased fat-infiltration, and tendon thinning indicates a worse outcome.
qCT (Low Dose CT)
Time frame: 5-Years Post-Allocation
Used to measure bone loss and density. Increased bone loss, and decreased density indicate a worse outcome.
Motion Analysis
Time frame: 5-Years Post-Allocation
A kinematic evaluation of the shoulder while performing functional tasks will help us determine how the rotator cuff muscle imbalance influences the shoulder joint kinematics.
Finite Element Analysis
Time frame: 5-Years Post-Allocation
This will be combined with motion analysis results to gain a better understanding of the internal loading within the tissues of the joint that could explain degenerative changes observed by imaging. Increased stresses, and muscle imbalance result in a worse outcome.
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 4 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of the Shoulder
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
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.
Peter Lapner, MD, FRCSC principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose CT, T1Rho MRI and Motion Analysis in people with Osteoarthritis of the Shoulder, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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 2 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
T1Rho MRI (time frame: 5-Years Post-Allocation). The study lists 4 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 4 Jul 2025.