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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT02958267
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients 40 to 70 years old
2. Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
3. Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
4. Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
5. Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
6. Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy
Exclusion Criteria:
1. Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
2. History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial
3. History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
4. Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
5. Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
6. Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic
7. Active infection of either lower extremity such as cellulitis or any skin disease or infection in the area where BMAC is aspirated, blood is drawn, or an injection is given
8. History of diagnosis of any of the following: 1) septic osteoarthritis of any joint, 2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses
9. Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee
10. Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator
11. Currently pregnant, nursing, or planning to become pregnant during the trial period
12. Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate; hyaluronan products or specifically Gel-One®; cinnamon; bird products such as feathers, eggs, or poultry; avian proteins
13. Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)
14. Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history as ad lib use of over-the-counter analgesics will be allowed in both groups after treatment
15. Current cigarette smoker
16. Unable to give informed consent
17. Non-English speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02958267
Study Brief:
Protocol Section:
NCT02958267