Glenohumeral Joint Contract Patterns in Osteoarthritic Glenoids

NCT06154694 | Recruiting

• 1 other identifier: S64986
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of Shoulder

Outcome Measures

Primary Outcomes (8)

• 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

Secondary Outcomes (2)

• Variations in glenohumeral contact areas

  2 years

• Influence of the location of the glenohumeral contact pattern

  2 years

Study Arms (3)

Shoulder osteoarthritis patients (prospective)

Patients with glenohumeral osteoarthritis with different types of osteoarthritic glenoids (A, B, C and D glenoids) scheduled for Total shoulder arthroplasty (TSA)

Radiation: Stereo Radiographic EOS Measurements

Healthy control group (prospective)

Healthy adult volunteers with no history of shoulder pain or trauma

Radiation: Stereo Radiographic EOS Measurements

Revision of glenoid component (retrospective)

Retrospectively included group of Total shoulder arthroplasty (TSA) patients who have been revised due to loosening of the glenoid component

Interventions

Stereo Radiographic EOS Measurements RADIATION

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

Healthy control group (prospective); Shoulder osteoarthritis patients (prospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Only patients with a functional TSA will be included, so patients with postoperative stiffness, pain, instability or pseudoparalysis will be excluded.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Officials

• Filip Verhaegen

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filip Verhaegen

CONTACT

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

Philippe Debeer

CONTACT

+32 16 33 88 37; philippe.debeer@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: December 4, 2023
• Study Start: November 3, 2021
• Primary Completion (Estimated): July 1, 2050
• Study Completion (Estimated): July 1, 2050
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

BE (1)