Health TrialsbyHealthPanel

Glenohumeral Joint Contract Patterns in Osteoarthritic Glenoids

ConditionOsteoarthritis of Shoulder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 adult volunteers with no history of shoulder pain or trauma

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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

Treatment groups

156 Participants
are divided into 3 treatment groups
Group A: Shoulder osteoarthritis patients (prospective)1 intervention
Group B: Healthy control group (prospective)1 intervention
Group C: Revision of glenoid component (retrospective)0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Secondary outcomes

1

Variations in glenohumeral contact areas

Determining possible variations in glenohumeral contact areas among patients with different type of osteoarthritic glenoids (A, B, C and D glenoids).

Time frame
2 years
2

Influence of the location of the glenohumeral contact pattern

Evaluate the influence of the location of the glenohumeral contact area and amount of their deviations from healthy subjects on the long-term outcome and survival of the glenoid component. Pre-operative and 2 years after surgery, a CT scan from OA group will be obtained , which will be used for evaluating long-term outcome and survival of the glenoid component .

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
Apply now