The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
226
ATX101 bupivacaine implants, total of 1,500 mg into the surgical site
bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration
normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Phoenix Clinical Research
Tamarac, Florida, United States
Atlanta Centre for Medical Research
Atlanta, Georgia, United States
Area under the curve (AUC) for the Numerical Rating Scale at Rest (NRS-R) of pain intensity
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Time frame: from 30 minutes through 168 hours (Day 8) compared to placebo
AUC for the NRS-R of pain intensity
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Time frame: 30 minutes through 336 hours (Day 15) compared to placebo
AUC for the NRS-R of pain intensity
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Time frame: from 30 minutes through 504 hours (Day 22) compared to placebo
Total post-surgical consumption of opioid medications
Time frame: from 30 minutes through 336 hours (Day 15) compared to placebo
AUC for the NRS-R of pain intensity
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Time frame: from 30 minutes through 336 hours (Day 15) compared to active comparator
Difference in NRS-A pain intensity scores during the Timed Up and Go (TUG) Test
The NRS with activity (NRS-A) for pain intensity is an 11-item scale from 0 to 10 where participants rank the level of pain intensity after an activity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NextStage Clinical Research
Wichita, Kansas, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, United States
First Surgical Hospital
Bellaire, Texas, United States
Legent Orthopedic Hospital
Carrollton, Texas, United States
Memorial Hermann Village
Houston, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
NextStage Clinical Research
San Antonio, Texas, United States
...and 1 more locations
Time frame: at Day 15 compared to placebo