Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores

• Status: Withdrawn
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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 with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing primary unilateral total knee arthroplasty.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adynxx, Inc.

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