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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT02276833
Eligibility Criteria:
Inclusion Criteria:
* Study Subject voluntarily gives written Informed Consent to participate in the study and signs the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
* The age range is from 20-70 years old.
* Both female and male participants are eligible.
* Females must be non-pregnant and those of child-bearing age will be pregnancy tested on-site at SMASA or RENEW on the day of, and prior to, surgery (Visit #2).
* Participants will be in good health (ASA Class I-II) with a BMI \< 35
* Failed a regimen of anti-inflammatory systemic medicines and/or physical therapy.
* Knee pain graded as greater than 4 out of 10.
* Mild to moderate arthritis as diagnosed by standard x-ray or MRI study.
* Patients will be eligible for in-office surgical procedures at SMASA and RENEW.
* Participants cannot be allergic to lidocaine, epinephrine, or valium.
* Must speak, read and understand English.
Exclusion Criteria:
* Outside of the age range (20-70 years old).
* BMI Index greater than 35.
* Severe to end stage osteoarthritis,Grade IV, as diagnosed by plain x-ray or MRI study.
* Hyaluronic acid gel injections to the affected knee joint within the last six months.
* Corticosteroid injections to the affected knee joint within the past 3 months.
* Current use of oral/systemic steroids.
* History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection, uncontrolled diabetes mellitus, immunodeficiency disorders (HIV), lipoatrophy disorders (scleroderma, lupus etc.), rheumatoid arthritis or any other medical condition causing chronic or clinically significant pain.
* Allergic to lidocaine, epinephrine, valium or sodium phosphate.
* Individuals with diminished decision-making capacity will not be included in this research study.
* All smokers and other tobacco users.
* Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02276833
Study Brief:
Protocol Section:
NCT02276833