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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT05492851
Eligibility Criteria:
Inclusion Criteria:
* Age 25-85 years
* BMI \< 40
* Diagnosis of unilateral knee OA
* Radiographic evidence of OA of the target knee (Kellgren-Lawrence grades 2-4)
* Continued OA pain in the target knee despite at least 6 weeks of: physical therapy and at least one of the following: activity modification (such as reducing impact on the knee), weight loss, and a 2 week trial of NSAID / acetaminophen.
* Knee Osteoarthritis Outcomes Score (KOOS)-Pain subscale 20-65
* Working knowledge of English language (to be able to complete all outcome scores)
* Ability to attend all follow-up appointments
Exclusion Criteria:
* 3+ effusion of the target knee (stroke test grading system)
* Prior injection therapy:
* Steroid injection in target knee in the last 3 months
* Viscosupplementation in target knee in the last 6 months
* PRP in the target knee in the last 6 months
* Cellular treatments in index knee (bone marrow, amniotic suspensions etc) 1 year
* Participation in any experimental device or drug study within 1 year before screening visit
* Oral or IM steroids in the last 3 months (Inhaled steroids used in the treatment of asthma/allergies are permitted)
* Medical condition that may impact outcomes of procedure including:
* Systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc
* Undergoing current cancer treatment (other than non-melanoma skin malignancies)
* Taking immunosuppressants
* Previous cartilage repair procedure on the injured cartilage surface (ie, OATS, ACI, MFX) in the last 5 years
* Previous surgery at the target knee within the past 1 year
* Any degree of cognitive impairment
* Symptomatic OA of any other joint in the lower limbs
* Pregnancy, lactating, or intent to become pregnant during treatment period (Female participants will be asked if they are pregnant, lactating, or intend to become pregnant during treatment)
* Gout, Pseudogout (including radiographic evidence of chondrocalcinosis)
* History of infection or current infection at the affected joint
* Smoking (Former smokers\< 1 year from quit date)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
85 Years
Study:
NCT05492851
Study Brief:
Protocol Section:
NCT05492851