None listed
Conditions
Brief summary
The primary objective of the study is to determine the amount of bupivacaine in the blood for adult subjects undergoing a total knee arthroplasty.
Interventions
TKAine is a bupivacaine HCl-releasing bioresorbable implant system that is placed within the knee capsule after a Total Knee Arthroplasty procedure at the time of surgery and prior to surgical closure of the knee capsule. Each TKAine depot is an implant that delivers bupivacaine drug with a polymer matrix that bioresorbs over time.
This is a dose ascending study where the total dose for each cohort is administered at one time at the time of surgery by an orthopaedic surgeon. The starting dos
TKAine is a bupivacaine HCl-releasing bioresorbable implant system that is placed within the knee capsule after a Total Knee Arthroplasty procedure at the time of surgery and prior to surgical closure of the knee capsule. Each TKAine depot is an implant that delivers bupivacaine drug with a polymer matrix that bioresorbs over time. This is a dose ascending study where the total dose for each cohort is administered at one time at the time of surgery by an orthopaedic surgeon. The starting dose is 300 mg bupivacaine hydrochloride monohydrate. The escalation schedule will be determined by the Data Safety Monitoring Board (DSMB) and can be escalated up to 8 TKAine depots at a total dose of 2400 mg bupivacaine hydrochloride monohydrate. Each cohort will be assessed by the DSMB prior to initiating the next cohort. Up to four total dose levels will be assessed. A minimum of 3 subjects will be enrolled in each of Cohort 1 and Cohort 2. A minimum of 6 subjects will be enrolled in each of Cohort 3 and Cohort 4. No more than 30 total subjects will be enrolled in the study from all the Cohorts combined.
Sponsors
Foundry Therapeutics 1, Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, greater than or equal to 18 and less than or equal to 80 years of age at the Screening Visit. 2. Female subjects only: Postmenopausal, surgically sterile, or willing to use acceptable means of contraception from the Screening Visit through the Final Follow-up Visit. Medically acceptable methods of contraception that may be used by the subject include birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom with spermicide, vaginal spermicidal suppository, or progestin implant or injection (used consistently for more than or equal to 3 months at the time of screening). Female subjects who are not of child bearing potential must have a medical history recorded of surgical sterilization (more than or equal to 6 months post-surgery at the time of screening) or post-menopausal (not experienced a menstrual period more than or equal to 2 years at the time of screening). 3. Scheduled to undergo primary unilateral TKA under anesthesia. 4. American Society of Anesthesiology (ASA) Physical Classification System class 1-2. ASA 3 is permitted if BMI is the only reason for classifying as ASA 3. 5. Primary indication of surgical procedure is knee pain. 6. Able and willing to comply with all study visits and procedures. 7. Willing and capable of providing written informed consent.
Exclusion criteria
1. Has a planned concurrent surgical procedure (e.g., bilateral TKA). 2. Has had any previous arthroplasty, unicompartmental knee arthroplasty or TKA in the study knee. 3. Has varus more than 10° and valgus more than 15°. 4. Has a pre-existing concurrent acute or chronic painful physical condition for which they routinely take narcotic analgesics other than for surgical knee. 5. Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications including surgical medications such as anesthesia. 6. Unable to abstain from opioid use for knee pain (including codeine) within 2 weeks (14 days) of surgery. 7. Has taken NSAIDs within 7 days prior to the scheduled surgery. (Does not include Celecoxib on day of surgery). 8. Has been administered any anesthetic including but not limited to bupivacaine, ropivacaine or lidocaine within 5 days prior to the scheduled surgery.
Outcome results
None listed