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:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT01621893
Eligibility Criteria:
Inclusion Criteria:
* Subject is 40-70 of age and skeletally mature
* Subject BMI is \< 40
* Subject has experienced pain in knee for at least 3 months
* BML is confirmed on T2 weighted MR Imaging by presence of white signal
* Subject has single BML of tibia, single BML of femur, or adjoining BML's of tibia \& femur
* Baseline KOOS pain subscore is ≤65
* Subject's involved knee alignment is defined radiographically as one of the following: Neutral, ≤ to 7 degrees mechanical varus or \< 7.5 degrees mechanical valgus
* Subject's ACL and PCL ligaments are intact
* Subject has failed no more than one operative treatment on treatment knee, and none within 6 months prior to enrollment
* Subject is willing and able to sign a written consent form
* The subject has the mental capacity and the willingness to comply with the specified follow-up evaluations, and can be contacted by telephone by the site personnel.
Exclusion Criteria:
* Surgeon deems subject's pain to be primarily related to an alternate condition such as a baker cyst, synovitis, meniscal pathology, or other
* BML caused by acute trauma
* Subject is not neurologically intact (sensory, motor, and reflex deficit)
* Subject is insulin dependent
* Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
* Subject with primary bone tumor in the knee area
* Subject anticipates having a lower extremity surgery other than the investigational surgery during the course of the study
* Subject has a history of substance abuse
* Subject is currently involved in another study or have received investigational product or treatment within the last 30 days
* Subject is pregnant or planning on becoming pregnant during the study period
* Subject is accepting workers' compensation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01621893
Study Brief:
Protocol Section:
NCT01621893