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:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT05788250
Eligibility Criteria:
Inclusion Criteria:
* 70 years of age or older
* clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear \>2cm or more than 1 full tendon
* ongoing symptoms after 3 months of physiotherapy
* a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
* absence glenohumeral arthritis (Hamada \< 3)
* absence of neoplastic diseases at treated site
Exclusion Criteria:
* previous surgery or pseudoparalysis on study shoulder
* complete subscapularis deficiency
* external rotation lag signs
* avascular necrosis
* post-infectious arthritis
* proximal humerus fracture
* inflammatory arithritis
* axillary nerve palsy
* concomitant tendon transfer
* neuromuscular disorder
* unable to speak/read English
Intra-operative Exclusion:
-tendon is NOT amenable to partial or complete repair
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT05788250
Study Brief:
Protocol Section:
NCT05788250