Study Assessing Pain Relief After Replacement of the Knee

Acute Postoperative Pain Clinical Trial

— SPARK  

Official title:

A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05260008
• Other study ID #: ATX-101-TKA-003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 7, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2024
• Source: Allay Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 305
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis.
• Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted).
• American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.

Exclusion Criteria:

• Has a planned concurrent surgical procedure.
• Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening.
• Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee.
• Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C.
• Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial.
• Unable to abstain from opioid use for knee pain within 14 days of surgery.
• Has been administered systemic steroids within 14 days prior to surgery.
• Has been administered any local anesthetic within 5 days prior to the scheduled surgery.
• Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease.
• Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications.
• Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments.
• Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome.
• Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has =10 years sobriety will be permitted.
• Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine.
• Has a Body Mass Index (BMI) =45 kg/m2.

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• ATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site
• ATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site
• bupivacaine hydrochloride without epinephrine
bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital / PARC Clinical Research	Adelaide	South Australia
Australia	St Andrew's Private Hospital	Adelaide	South Australia
Australia	Prince of Wales Private Hospital	Sydney	New South Wales
Australia	John Flynn Private Hospital	Tugun	Queensland
Australia	The Avenue Private Hospital	Windsor	Victoria
Canada	Durham Bone and Joint Specialists	Ajax	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
United Kingdom	Department of Trauma and Orthopaedic Surgery, Addenbrooke's Hospital	Cambridge	Cambridgeshire
United Kingdom	Chapel Allerton Hospital C/O The Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire
United Kingdom	Nottingham Elective Orthopaedic Service, Nottingham University Hospitals	Nottingham	Nottinghamshire
United Kingdom	Robert Jones & Agnes Hunt Orthopaedic Hospital	Oswestry	Shropshire
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United Kingdom	Royal National Orthopaedic Hospital	Stanmore	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Allay Therapeutics, Inc.

Countries where clinical trial is conducted

Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.		from 30 minutes post-surgery through hour 168
Secondary	Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.		from 30 Minutes post-surgery through Hour 168, Hour 240, and Hour 336
Secondary	Percentage of subjects who remain opioid free.		from Hour 72 post-surgery through Day 30
Secondary	Total post-surgical consumption of opioid medications.		from surgical closure through Day 30
Secondary	Area under the curve for the Numeric Rating Scale at Rest (NRS-R) of pain intensity.		from surgical closure for each 24-hour period through Hour 336
Secondary	Percentage of subject who remain opioid free.		Surgical Closure to Day 30
Secondary	Total post-surgical use of rescue opioid medications.		Surgical Closure to Day 30
Secondary	Time to first postsurgical use of rescue opioid medication.		Surgical Closure to Day 30