Unravelling the Etiology of Shoulder Osteoarthritis

NCT04634773 | Active Not Recruiting

• 1 other identifier: 20200766-01H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis of the Shoulder

Keywords

T1Rho MRI; qCT; Motion Analysis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  5-Years Post-Allocation

Study Arms (2)

Group 1: Early Degeneration ('Disease')

EXPERIMENTAL

Those who have posterior subluxation of the humeral head and show early signs of degeneration in their shoulder.

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.

Radiation: Low-dose CT; Other: T1Rho MRI; Other: Motion Analysis

Interventions

Low-dose CT RADIATION

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.

Group 1: Early Degeneration ('Disease'); Group 2: No Degeneration ('Healthy')

T1Rho MRI OTHER

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.

Group 1: Early Degeneration ('Disease'); Group 2: No Degeneration ('Healthy')

Motion Analysis OTHER

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 1: Early Degeneration ('Disease'); Group 2: No Degeneration ('Healthy')

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults \<60 years of age
• Posterior humeral head subluxation \>55% (determined from imaging)

You may not qualify if:

• \>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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator

Study Sites (2)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Carleton University

Ottawa, Ontario, K1S5B6, Canada

Location

Study Officials

• Peter Lapner, MD, FRCSC

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: June 23, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)