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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03445494
Eligibility Criteria:
Inclusion Criteria:
* Males or females between 18 and 65 years old;
* Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;
* Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;
* Presence of adipose degeneration ≤ 2 according to Goutallier;
* Written informed consent to participate in the study
Exclusion Criteria:
* Presence of a lesion of other rotator cuff tendons;
* Previous surgical procedures of the shoulder;
* Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;
* Presence of relapsing shoulder dislocations;
* Presence of lesions of the glenoidine cercine that require intervention;
* Difficulties to follow the rehabilitation programs;
* Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients;
* State of pregnancy (presumed or established) or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT03445494
Study Brief:
Protocol Section:
NCT03445494