Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen (NCT03974932) | Clinical Trial Compass
CompletedPhase 3
Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
United States116 participantsStarted 2019-06-05
Plain-language summary
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 bupivacai…
What they're measuring
1
Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).