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Active, not recruiting Not applicable

Unravelling the Etiology of Shoulder Osteoarthritis

NCT04634773 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2021-06-23
Last updated
2025-07-04

Condition(s) studied

Osteoarthritis of the Shoulder

Investigational drug(s) / intervention(s)

Low-dose CTT1Rho MRIMotion Analysis

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.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
Inclusion Criteria: * Adults \<60 years of age * Posterior humeral head subluxation \>55% (determined from imaging) Exclusion Criteria: * \>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)

Primary outcome measure(s)

  • T1Rho MRI — 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) — 5-Years Post-Allocation
    Used to measure bone loss and density. Increased bone loss, and decreased density indicate a worse outcome.
  • Motion Analysis — 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 — 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.

Trial sites (2)

FacilityCityRegionStatus
University of Ottawa Ottawa Ontario
Carleton University Ottawa Ontario

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04634773 on ClinicalTrials.gov ↗ ← All trials in Canada