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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT01895959
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 80 years
* Symptomatic knee OA as defined by the American College of Rheumatology criteria
* Kellgren-Lawrence grade I, II or III on prior x-rays (take within 6 months of screening visit)
* knee pain score \>40 mm on a 100 mm visual analogue scale for \> 15 days in the last month
* NSAIDs permitted if the dose has been stable for at least one month prior to baseline and stays stable during the study
* Have been recommended for Euflexxa treatment by physician
* Knee effusion based on clinical exam or imaging
Exclusion Criteria:
* Any contraindication to MRI (pregnancy, metallic fragments in the eyes, vascular clips, Pacemakers etc)
* History of knee replacement
* Known sensitivity or allergy to any component of Euflexxa
* Inflammatory arthritis
* Previously received viscosupplementation therapy within 6 months of study enrollment
* Intra-articular injection of corticosteroid to study joint within the past 3 months
* Arthroscopic or open surgery within the previous 12 months or planned surgery to the study joint
* Concomitant medications of oral/parenteral corticosteroids
* Morbid obesity defined as body mass index (BMI) \>40 kg/m2
* Active malignancy; an active systemic infection; recent high impact or high energy trauma (clinically defined) to the study joint
* Large knee effusion based on clinical exam or imaging
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01895959
Study Brief:
Protocol Section:
NCT01895959