NCT06154694|Recruiting
Glenohumeral Joint Contract Patterns in Osteoarthritic Glenoids
TSA
In-vivo Evaluation of Glenohumeral Joint Contact Patterns in Osteoarthritic Glenoids
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TSA
In-vivo Evaluation of Glenohumeral Joint Contact Patterns in Osteoarthritic Glenoids
Sponsor study identifier
observational
156
1 country
1
Study Start
November 3, 2021
Actual (reported)Primary Completion
July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 3, 2021
Actual (reported)October 31, 2023
Actual (reported)December 4, 2023
Actual (reported)July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Compere In-vivo glenohumeral joint contact patterns in patients using EOS stereo radiographic imaging
Evaluating in-vivo glenohumeral joint contact patterns in patients with different type of osteoarthritic glenoids pre- and post-TSA. Glenohumeral contact areas are compared before and after surgery in patients with osteoarthritic glenoids, using EOS stereo radiographic imaging
2 years
Compere in-vivo glenohumeral joint contact patterns in healthy subjects using EOS stereo radiographic imaging
Evaluating glenohumeral joint contact patterns in healthy subjects and comparing them with patients with osteoarthritic glenoids before patients receive surgery and after patients receive surgery. Glenohumeral contact areas are compared using EOS stereo radiographic imaging
2 years
Pre-operative factor: Humeral Head Migration
Identifying probable pre-operative factors; for example the amount of HHM; on glenohumeral contact area after surgery using pre- and postoperative CT scans.
2 years
Pre-operative factor: Inclination and rotator cuff muscle's quality
Identifying probable pre-operative factors; for example the inclination and rotator cuff muscle's quality; on glenohumeral contact area after surgery using pre- and postoperative CT scans.
2 years
Pre-operative factor: Degree of glenoid version
Identifying probable pre-operative factors; for example the degree of glenoid version; on glenohumeral contact area after surgery using pre- and postoperative CT scans.
2 years
Intra-operative factors: Degree of glenoid orientation correction
Identifying probable intra-operative factors; for example the degree of glenoid orientation correction; on glenohumeral contact area after surgery.
2 years
Intra-operative factors: Joint-line medialization
Identifying probable intra-operative factors; for example the joint-line medialization; on glenohumeral contact area after surgery.
2 years
Amount of osteolysis inside the glenoid vault and around glenoid component
Evaluating the amount of osteolysis inside the glenoid vault and around glenoid component of the patients at least 2 years after surgery
2 years
Variations in glenohumeral contact areas
2 years
Influence of the location of the glenohumeral contact pattern
2 years
Patients with glenohumeral osteoarthritis with different types of osteoarthritic glenoids (A, B, C and D glenoids) scheduled for Total shoulder arthroplasty (TSA)
Healthy adult volunteers with no history of shoulder pain or trauma
Retrospectively included group of Total shoulder arthroplasty (TSA) patients who have been revised due to loosening of the glenoid component
Healthy control will undergo a stereo radiographic EOS exam with their arm in various positions. 1. Relaxed standing (0 degree of abduction) 2. 45 degree of abduction in the coronal plane 3. 90 degree of abduction in the coronal plane 4. 120 degree of abduction in the coronal plane 5. 45 degree anterior flexion in the sagittal plane 6. 90 degree anterior flexion in the sagittal plane 7. 120 degree of anterior flexion in the sagittal plane 8. 45 degree extension in the sagittal plane
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Both OA patients and Healthy control group are screened in UZ Leuven for the prospective part of this study. Revised TSA patients because of glonoid component loosening are screened for the retrospective part of the study.
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Filip Verhaegen
Universitaire Ziekenhuizen KU Leuven
First Submitted
October 31, 2023
First Posted
December 4, 2023
Study Start
November 3, 2021
Actual (reported)Primary Completion
July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
July 1, 2050
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 2, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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