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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00223795
Eligibility Criteria:
Inclusion Criteria:
* 45-85 years old
* Able to walk 30 feet without postural sway and able to stand unaided
* Knee pain on movement with a WOMAC pain subscale of \>35mm
* Documented osteoarthritis based on clinical and radiographic criteria
* Body Mass Index (BMI) \> 25.0 - 29.9
* Ability to understand verbal and written instructions
* Ability to give informed consent determined by assessment of cognitive status
Exclusion Criteria:
* Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy. History of knee trauma or surgery, including arthroscopic surgery, in the past six months
* Severe obesity (weight \> 300lbs)
* Upper body weakness
* Injury or amputation of the lower extremity joints
* History of other types of arthritis
* Spine, foot, or hip pain of sufficient magnitude to interfere with the evaluation of the index joint.
* Isolated patellofemoral disease manifested by primarily anterior knee pain in the absence of tibiofemoral radiographic finding.
* History of significant collateral or anterior cruciate ligament or meniscal injury to the index joint requiring at least one week of non weight bearing (minor ligamentous injury prior to 6 months is not an exclusion).
* Poor health that would impair compliance or assessment such as shortness of breath with exertion
* Neurological disease including vestibular dysfunction, or impaired vision
* Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
* Is unable to understand and complete the study questionnaires including visual analog scale (VAS) responses.
* Is unable to understand the study procedures.
* Investigator feels the patient is otherwise inappropriate for the study. The patient is participating in another clinical trial that would interfere with participation in this study
* Investigator feels the patient is otherwise inappropriate for the study.
* The patient is participating in another clinical trial that would interfere with participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT00223795
Study Brief:
Protocol Section:
NCT00223795