Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00477360
Eligibility Criteria:
Pre-Operative Inclusion Criteria:
* Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)
* Persistent pain and disability for at least 6 months
* Imaging demonstrates advanced humeral head cartilage loss
Pre-Operative Exclusion Criteria:
* Active or systemic joint infection
* Significant muscle paralysis of shoulder girdle
* Charcot's Arthropathy
* Major medical illness (life expectancy \<2years)
* Unable to speak and read English/French
* Psychiatric illness that precludes informed consent
* Unwilling/unable to remain in study for one year
Intra-Operative Inclusion Criteria:
Advanced humeral head cartilage loss AND ONE of:
* minimal/no glenoid cartilage loss
* complete glenoid cartilage loss and no bony erosion
* complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation
Intra-Operative Exclusion Criteria:
* Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head
* Inability of humeral head to support the CAP surface replacement
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00477360
Study Brief:
Protocol Section:
NCT00477360