Unravelling the Etiology of Shoulder Osteoarthritis

NCT04634773 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-04

No results posted yet for this 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.

Conditions

  • Osteoarthritis of the Shoulder

Interventions

RADIATION

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • University of Ottawa

    collaborator OTHER
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Peter Lapner, MD, FRCSC · The Ottawa Hospital Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634773 on ClinicalTrials.gov