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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT03295994
Eligibility Criteria:
Inclusion Criteria:
* Aged =\>40 years to \<85 years
* Shoulder pain and/or loss of range of active motion, strength or function
* MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
* Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
* Ability and willingness to provide informed consent
Exclusion Criteria:
* Primary diagnosis is something other than a rotator cuff tear
* History (in last 2 years) of shoulder fracture involving the humeral head on affected side
* Previous rotator cuff surgery on affected side
* Isolated subscapularis \&/or teres minor tear on affected side
* Acute rotator cuff tear caused by a severe trauma
* Shoulder used as a weight-bearing joint
* Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
* Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD
* Grade 4 fatty infiltration of rotator cuff (any tendons)
* Candidate for shoulder arthroplasty at baseline
* Non-English speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
84 Years
Study:
NCT03295994
Study Brief:
Protocol Section:
NCT03295994