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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT03130335
Eligibility Criteria:
Inclusion Criteria:
* \>=3 months of symptomatic knee OA unresponsive to at least two of the following: activity modification, physical therapy, bracing, assistive devices, acupuncture, non-steroidal anti-inflammatory medications, local steroid injections, and hyaluronic acid injections
* Radiographically confirmed Kellgren-Lawrence I-II knee OA (mild knee OA; no bone-on-bone)
* Age 18-79 years
Exclusion Criteria:
* Presence of loose bodies on baseline magnetic resonance imaging
* Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiences
* History of meniscal injury other than degenerative meniscal tears
* Previous knee surgery
* Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
* Intra-articular injection to affected knee within 6 weeks of intra-articular BMA injection
* Mechanical axis deviation greater than 7 degrees
* Intolerance to acetaminophen or hydrocodone (i.e., Vicodin)
* Use of non-steroidal anti-inflammatory drugs \<1 weeks prior to BMA
* Injection of the joint scheduled for treatment within 3 months of BMA injection
* Body mass index of 30 or more
* History of drug abuse
* Current cigarette smokers
* Current use of systemic steroids
* History of or current alcohol abuse or dependence
* History of anemia, bleeding disorders, or inflammatory joint disease
* Active infection
* Active malignancy per medical or surgical history, diagnosed by primary case physician or treating specialist, undergoing treatment, has undergone treatment, or has declined treatment
* Inability to refrain from statin regimen from 1 month pre-injection to 1 month post-injection
* Pregnancy or breastfeeding at time of treatment
* Participating or planning to participate in a worker's compensation program at the time of treatment or follow-up period
* Pending or planned legal action pertaining to knee pain
* Non-English speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT03130335
Study Brief:
Protocol Section:
NCT03130335