RecruitingNot Applicable

Glenohumeral Joint Contract Patterns in Osteoarthritic Glenoids

Belgium156 participantsStarted 2021-11-03

Plain-language summary

Shoulder osteoarthritis (OA) is a frequent problem in our aging population and is believed to occur in up to 20% of the population. Different types of glenoid morphology are associated with shoulder OA, depending on the amount and localization of the glenoid erosion as well as the amount and direction of Humeral Head Migration. Total shoulder arthroplasty (TSA) has been shown to relieve the pain and improve joint function of patients with OA. However, several complications such as component loosening and polyethylene damage has been reported and it has been revealed that 7.3% of glenoids may show signs of asymptomatic radiographic loosening annually after primary anatomic TSA. The mechanism of such fixation failure is still unclear. The main goal of this study is evaluating in-vivo glenohumeral contact patterns in patients with osteoarthritic glenoids before and after TSA, to unravel the high rate of glenoid component loosening.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: OA patients group * Patients with glenohumeral osteoarthritis planned for anatomic shoulder arthroplasty in the University Hospitals Leuven, Belgium * Complete patient informed consent * Pain free at the time of EOS imaging Healthy control group * Healthy adult volunteers with no history of shoulder pain or trauma * Confirmation of the physician, that subject's clinical evaluation and CT scan did not show any abnormalities * Complete informed consent Revised TSA group * Patients with glenohumeral osteoarthritis who received an anatomic shoulder arthroplasty at the University Hospitals Leuven within the past 30 years, and who have been revised for loosening of the glenoid component. * At least 1 postoperative CT scan available Exclusion Criteria: Only patients with a functional TSA will be included, so patients with postoperative stiffness, pain, instability or pseudoparalysis will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compere In-vivo glenohumeral joint contact patterns in patients using EOS stereo radiographic imaging

Timeframe: 2 years

Compere in-vivo glenohumeral joint contact patterns in healthy subjects using EOS stereo radiographic imaging

Timeframe: 2 years

Pre-operative factor: Humeral Head Migration

Timeframe: 2 years

Pre-operative factor: Inclination and rotator cuff muscle's quality

Timeframe: 2 years

Pre-operative factor: Degree of glenoid version

Timeframe: 2 years

Intra-operative factors: Degree of glenoid orientation correction

Timeframe: 2 years

Intra-operative factors: Joint-line medialization

Timeframe: 2 years

Trial details

NCT IDNCT06154694

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2050-07-01

Contact for this trial

Filip Verhaegen

+32 16 33 88 27 filip.verhaegen@uzleuven.be

View on ClinicalTrials.gov More Osteoarthritis of Shoulder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Compere In-vivo glenohumeral joint contact patterns in patients using EOS stereo radiographic imaging

Timeframe: 2 years

Compere in-vivo glenohumeral joint contact patterns in healthy subjects using EOS stereo radiographic imaging

Timeframe: 2 years

Pre-operative factor: Humeral Head Migration

Timeframe: 2 years

Pre-operative factor: Inclination and rotator cuff muscle's quality

Timeframe: 2 years

Pre-operative factor: Degree of glenoid version

Timeframe: 2 years

Intra-operative factors: Degree of glenoid orientation correction

Timeframe: 2 years

Intra-operative factors: Joint-line medialization

Timeframe: 2 years