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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT03797612
Eligibility Criteria:
Inclusion Criteria:
* Score of 16 or greater on the PCS scale
* Scheduled for primary unilateral TKA with spinal anesthesia as the primary anesthetic for painful osteoarthritis without congenital knee pathology
* American Society of Anesthesiologists Physical Status Classification System ≤ 3
* Medically stable for elective surgery with spinal anesthetic as determined by the Investigator
* Body mass index of 18-45 kg/m2
* Stable medical regimen at least 1 week before randomization
* Able to read and understand study instructions in English or Spanish, and willing to comply with all study procedures
Exclusion Criteria:
* Target knee \> 20 degrees valgus or varus deformity, evidence of significant bone loss or ligamentous laxity, or existing major hardware that requires removal during TKA
* Inflammatory arthridities (e.g., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis), with the exception of clinically stable/non-active gout
* Undergoing concomitant surgical procedures or non-elective TKA, or contralateral knee is likely to require TKA within 6 weeks (or would interfere with study assessments)
* Use of cryoneurolysis (including Iovera) on the current operative knee region within 6 months prior to randomization and/or at any time through the duration of the study
* Planned use of general anesthesia as the primary anesthetic; planned use of neuroaxial (intrathecal or epidural) opioids, or any use of extended release/long acting opioids or ketamine preoperatively and/or at any time through the duration of the study
* Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
* Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinson's, Multiple Sclerosis)
* Unstable mental condition and/or evidence of an uncooperative attitude in the opinion of the Investigator; subjects diagnosed with schizophrenia, prescribed antipsychotic medications or MAOIs
* Women who are pregnant or nursing
* Subjects engaged in pending or active litigation, or seeking disability compensation; subjects whose cases have been settled or finally decided are not excluded
* Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned participation in a clinical trial during this study
* Previous participation in any study involving brivoligide injection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03797612
Study Brief:
Protocol Section:
NCT03797612