This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Prince of Wales Private Hospital
Sydney, New South Wales, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
Area Under the Curve (AUC) for the Numeric 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 post-surgery through hour 168 (Day 8)
Percentage of Subject Who Remain Opioid Free.
Opioid free is defined as no opioid rescue medication was recorded for the timepoint displayed and onwards.
Time frame: Surgical Closure to Day 30
Total Post-surgical Use of Rescue Opioid Medications.
Total post-surgical use of rescue opioid medications (days).
Time frame: Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30
Time to First Rescue Opioid Medication.
Time to first postsurgical use of rescue opioid medication (days).
Time frame: Surgical Closure to Day 30
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Royal Adelaide Hospital / PARC Clinical Research
Adelaide, South Australia, Australia
St Andrew's Private Hospital
Adelaide, South Australia, Australia
The Avenue Private Hospital
Windsor, Victoria, Australia
Durham Bone and Joint Specialists
Ajax, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Department of Trauma and Orthopaedic Surgery, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Royal National Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom
...and 3 more locations