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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04929951
Eligibility Criteria:
Inclusion Criteria:
* Age between 25 and 75 years-old
* Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
* Working understanding of the English language and able to fully understand the procedure
* Capable of providing informed consent
* Able to complete online, in-person or phone surveys for the purposes of follow-up
* Capable of understanding pre- and post-procedure care instructions
* Ambulatory at baseline
* Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.
Exclusion Criteria:
* Age \< 25 or \> 75 years old
* Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis
* Prior total or partial joint replacement surgery or surgery involving cartilage regeneration
* Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months
* Co-morbidity with the rheumatologic condition, inflammatory arthritis
* Currently undergoing immunomodulatory therapy
* Uncontrolled endocrine disorder
* BMI \>40 or joint space not visible by ultrasound
* Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection, and poorly controlled diabetes (HgA1C \>7.0)
* Pregnancy or planned pregnancy
* previous stem cell injection into treatment joint
* Patient scheduled to undergo any concomitant shoulder surgical procedures or other surgery which may affect outcomes.
* Coagulopathy or anticoagulant treatment
* Chronic pain involving multiple body parts or opioid medication management
* Diagnosis of fibromyalgia
* Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT04929951
Study Brief:
Protocol Section:
NCT04929951