Status:
WITHDRAWN
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores
Lead Sponsor:
Adynxx, Inc.
Conditions:
Pain, Postoperative
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients w...
Detailed Description
The objective of this study is to evaluate the safety and postoperative pain reducing efficacy of a single preoperative intrathecal administration of brivoligide injection in patients with a Pain Cata...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03797612
Start Date
January 1 2021
End Date
February 1 2022
Last Update
July 13 2020
Active Locations (2)
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1
Research Site
Sheffield, Alabama, United States, 35660
2
Research Site
Phoenix, Arizona, United States, 85023