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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT03886259
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 19-40
* Subjects with primary total knee arthroplasty due to osteoarthritis ≥ 12 months post-operatively
* For the index knee, duration of knee pain \> 6 months
* For the index knee, the average daily pain score ≥ 4 (moderate-to-severe pain) over the last week prior to visit on a numeric rating scale
Exclusion Criteria:
* Specific reasons for chronic pain, such as loosening of implant, which requires revision surgery
* Secondary causes of arthritis to the knee, e.g. rheumatoid arthritis
* Surgery (including arthroscopy) of the index knee within 3 months prior to visit
* Injury to the index knee within 12 months prior to visit
* Recent history of acute pain affecting the lower limb and/or trunk
* Participation in other pain trials two weeks prior to this study
* Pregnancy
* Drug and alcohol abuse
* Previous neurologic illnesses or primary pain area other than knee, e.g. lower back, upper extremity pain or rheumatoid arthritis
* Lack of ability to adhere to protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03886259
Study Brief:
Protocol Section:
NCT03886259