Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2021-06-23
2027-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group 1: Early Degeneration ('Disease')
Those who have posterior subluxation of the humeral head and show early signs of degeneration in their shoulder.
Low-dose CT
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 MRI
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 Analysis
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.
Group 2: No Degeneration ('Healthy')
Those who have posterior subluxation of the humeral head and show no signs of degeneration.
Low-dose CT
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 MRI
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 Analysis
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.
Interventions
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Low-dose CT
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 MRI
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 Analysis
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.
Eligibility Criteria
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Inclusion Criteria
* Posterior humeral head subluxation \>55% (determined from imaging)
Exclusion Criteria
* 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)
18 Years
59 Years
ALL
No
Sponsors
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University of Ottawa
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Peter Lapner, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital Research Institute
Locations
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University of Ottawa
Ottawa, Ontario, Canada
Carleton University
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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20200766-01H
Identifier Type: -
Identifier Source: org_study_id
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