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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01333527
Eligibility Criteria:
Inclusion Criteria:
1. Patient is over 18 years of age
2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Exclusion Criteria:
1. Patient has a full-thickness tear of the subscapularis and/or teres minor
2. Patient has undergone previous RC surgery to the affected shoulder
3. Patient has major joint trauma, infection, or avascular necrosis
4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
6. Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
7. Patient has a major medical illness where life expectancy is less than 2 years
8. Patient does not speak/read/understand English
9. Patient has no fixed address or means of contact
10. Surgeon or patient has decided to cancel surgery
11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
12. Patient unwilling to complete necessary follow-ups
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01333527
Study Brief:
Protocol Section:
NCT01333527