Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty
1 other identifier
interventional
116
1 country
6
Brief Summary
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedStudy Start
First participant enrolled
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2021
CompletedResults Posted
Study results publicly available
August 31, 2023
CompletedMarch 2, 2026
February 1, 2026
1.5 years
June 3, 2019
December 17, 2021
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).
The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
12 through 48 hours
Secondary Outcomes (18)
Mean AUC of VAS Scores.
72 hours
Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).
72 hours
Percentage of Subjects With Severe Pain.
24 hours, 48 hours, 72 hours
Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).
72 hours
Percentage of Subjects Who Are Opioid-free
72 Hours to Day 11
- +13 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALHTX-011 + MMA
Cohort 2
EXPERIMENTALHTX-011 + MMA
Cohort 3
EXPERIMENTALHTX-011 + MMA
Cohort 4
EXPERIMENTALHTX-011 + MMA
Interventions
Eligibility Criteria
You may qualify if:
- Is scheduled to undergo primary unilateral TKA under spinal anesthesia.
- Has not previously undergone TKA in either knee.
- Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Is able to walk at least 20 feet with optional use of a 4-legged walker for balance.
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives.
You may not qualify if:
- Has a planned concurrent surgical procedure.
- Has other pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Using or expected to use Factor IX Complex or anti-inhibitor coagulant concentrates during the study.
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- Has taken NSAIDs within 10 days prior to the scheduled surgery with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
- Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
- Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
- Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
- Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
- Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
- Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Helen Keller Hospital
Sheffield, Alabama, 35660, United States
Phoenix Clinical Research, LLC
Tamarac, Florida, 33321, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Plano Surgical Hospital
Plano, Texas, 75093, United States
Endeavor Clinical Trials, LLC.
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tricia Mulford
- Organization
- Heron Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2019
First Posted
June 5, 2019
Study Start
June 5, 2019
Primary Completion
December 7, 2020
Study Completion
January 7, 2021
Last Updated
March 2, 2026
Results First Posted
August 31, 2023
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share