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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT00653432
Eligibility Criteria:
Main Inclusion Criteria:
* Male or Female
* Age 35 to 75 years
* Body Mass Index (BMI) 20 to 40 kg/m2
* Willing and able to provide informed consent
* Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection
* Not pregnant or lactating
* Previous conservative treatment regimen for osteoarthritis (OA)
* Diagnosis of idiopathic OA of the index knee
* OA symptoms for \>= 6 months
* Index knee Kellgren-Lawrence (K-L) grade of II or III
* Index knee Baseline Summed WOMAC Pain Score \>= 200mm and \< 400mm after NSAID washout
* Contralateral Knee K-L grade 0, I or II
* Contralateral Knee Baseline WOMAC Pain Score \< 150mm after NSAID washout
Main Exclusion Criteria:
* Joint disorders which could interfere with treatment effectiveness
* Joint disorders which could interfere with study assessments
* Arthroscopy of either knee within 3 months of screening
* Open surgery of index knee within 12 months of screening
* Open surgery of contralateral knee within 3 months of screening
* Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening
* Injection of steroid in index knee within 3 months of screening
* Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection
* Synovial fluid aspirate volume \> 20 milliliters (mL)
* Visual appearance of synovial fluid that contraindicates injection
* Index knee range of motion \< 90 degrees
* Subject participation in other research study within 30 days of screening
* Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study
* Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable
* Other medication or treatments that could interfere with study injection or assessments
* Allergy to gram positive bacterial products or intolerance of acetaminophen
* Active fibromyalgia
* Peripheral neuropathy severe enough to interfere with evaluation of either knee
* Vascular insufficiency severe enough to interfere with evaluation of the subject
* Hemiparesis involving either lower extremity
* Systemic bleeding disorder
* Other conditions which may adversely affect the success of the procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00653432
Study Brief:
Protocol Section:
NCT00653432