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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT04299802
Eligibility Criteria:
Inclusion Criteria:
* Males and Females 18 - 70 years of age (inclusive)
* Clinical symptoms for a minimum of three months
* Subjects have a baseline pain score of \> 3
* Partial-thickness gluteal tendon tear (gluteus medius or gluteus minimus) defined as \<50% partial-thickness tear of either tendon or imaging abnormalities consistent with tendinosis on a 3 Tesla MRI or diagnostic ultrasound within the last 3 months, as determined by the Investigator
Exclusion Criteria:
* Age \< 18 or \> 70
* Corticosteroid injection in the index gluteal bursae within the last 3 months
* Subjects who have received more than one (1) previous corticosteroid injections or percutaneous tenotomy procedure or any biologic treatment in the index gluteal bursae at any point in the past.
* Severe arthrosis of the femoral-acetabular joint
* A high-grade gluteal tendon tear (\>50% partial-thickness tear)
* Previous hip surgery on the affected side
* Previous or current history of labral pathology on the affected side
* Lumbar radiculopathy impacting the index hip
* History of systemic malignant neoplasms within the last 5 years
* Malignant or local neoplasm within the last 6 months or any history of local neoplasm at the site of administration (on the affected side)
* Receiving immunosuppressive therapy
* Active regimen of chemotherapy or radiation-based treatment
* Allergy to sodium citrate or any "caine" type of local anesthetic
* Pregnancy
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. (Non-interventional observational studies are not exclusionary.)
* Active workman's compensation case in progress
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04299802
Study Brief:
Protocol Section:
NCT04299802