Glenohumeral Joint Contract Patterns in Osteoarthritic Glenoids

NCT ID: NCT06154694

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2026-07-01

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.

Detailed Description

Shoulder osteoarthritis (OA) is a frequent problem in our aging population and is believed to occur in up to 20% of the population. OA leads to pain, restriction of movement and functional disability. Furthermore, chronic instability, characterized by humeral head migration (HHM), and pathologic changes of the glenoid bone, i.e. glenoid erosions, is common in OA. 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 HHM. On the basis of these factors glenoids are classified in A, B, C and D types 4. In this classification A glenoid is a centered or symmetric arthritis without posterior subluxation of the humeral head. The B glenoid is characterized by asymmetric bone erosion, leading to glenoid retroversion, combined with posterior HHM. The D glenoid is defined by glenoid anteversion or anterior humeral head subluxation, while C glenoid is a dysplastic glenoid with at least 25° of retroversion "not caused by erosion.

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. Although, aberrant glenohumeral contact mechanics has been suggested to be one of the primary potential causes, the mechanism of such fixation failure is still unclear. Glenohumeral conformity, eccentric loads associated with shoulder instability, bone quality, cementing techniques, implant orientation and design are all confounding factors that indeed affect the mechanical environment of the glenoid component, and, more specifically, also in terms of the contact mechanics.

Knowledge of in vivo glenohumeral joint contact mechanics before and after total shoulder arthroplasty and its interplay with patient- and surgery-related parameters may unravel the high rate of glenoid component loosening in patients with osteoarthritic glenoids and provide insight for the improvement of patient function, implant designs, implant longevity, and surgical technique. Previous ex-vivo and computational modelling studies that focused on the glenohumeral contact area after TSA, suggested that arm elevation in the scapular plane results in aberrant posterior translation of the humeral head in TSA patients. However, an in-vivo study based on dual-plane fluoroscopy, demonstrated that this only occurs in 50% of TSA patients. These discrepancies could arise from analyzing an assorted population of TSA patients without taking into account any specific information with regards to their preoperative osseous and soft-tissue status such as type of glenoid erosion, degree of glenoid retroversion, and amount of rotator cuff degeneration. Postoperative factors such as degree of retroversion correction, amount of joint-line medialization and glenohumeral components' radial mismatch were also not considered in these studies.

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. To that aim, the project is divided into four sub-objectives. The first objective is to compare glenohumeral contact areas before and after surgery in patients with osteoarthritic glenoids, using EOS (micro-dose x-ray) stereo radiographic imaging, to evaluate whether osseous correction during surgery is able to correct glenohumeral joint kinematics. The second objective is to compare OA patient's glenohumeral contact areas before and after surgery with healthy subjects. The third objective is to identifying variations in glenohumeral contact patterns after surgery with respect to the pre-and postoperative state of the patients. The last objective is to evaluate the influence of the location of the glenohumeral contact area after surgery on the long-term outcome and survival of the glenoid component.

Conditions

Osteoarthritis of Shoulder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Shoulder osteoarthritis patients

Patients with glenohumeral osteoarthritis

Stereo Radiographic EOS Measurements

Intervention Type: 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

Healthy adult volunteers with no history of shoulder pain or trauma

Stereo Radiographic EOS Measurements

Intervention Type: 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

Interventions

Stereo Radiographic EOS Measurements

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

Intervention Type: RADIATION

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Filip Verhaegen

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Filip Verhaegen

Role: CONTACT

filip.verhaegen@uzleuven.be

+32 16 33 88 27

Philippe Debeer

Role: CONTACT

philippe.debeer@uzleuven.be

+32 16 33 88 37

Facility Contacts

Filip Verhaegen

Role: primary

filip.verhaegen@uzleuven.be

+3216338827

Philippe Debeer

Role: backup

philippe.debeer@uzleuven.be

+3216338837

Other Identifiers

S64986

Identifier Type: -

Identifier Source: org_study_id