Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioTissue Holdings, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female, greater than 18 years of age
2. Primary diagnosis of unilateral osteoarthritis of the knee
3. Scheduled to undergo primary, unilateral TKA
4. ASA physical status 1, 2, or 3
You may not be if
1. Patient has concurrent painful physical condition not strictly related to the knee surgery that may require analgesic treatment (such as NSAIDs or opioid) that may confound postsurgical assessments as determined by the investigator
2. Patient on chronic daily narcotic medication for knee pain based on medical history and Florida Prescription Drug Monitoring Program (E-FORCSE)
3. Allergy or contraindication to any of the study medications
4. Patient reported renal impairment based on medical history
5. Bodyweight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
6. History of previous fracture or open surgery on the knee being considered for TKA
7. History of patellar instability, e.g., Valgus deformity
8. History of inflammatory arthropathy (e.g., Rheumatoid arthritis, Lupus, etc.)
9. Use of cryoneurolysis, or cryoanalgesia, including iovera® device (Myoscience, Fremont, CA) on the operative knee within the last 6 months or planned during study duration
10. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might impact postsurgical pain or confound postsurgical assessments
11. Planned use of intra-articular steroid injections during the study.
12. Received any local anesthetic within 7 days of the planned TKA procedure aside from those part of the protocol
13. Planned use of potent inhalational agents or peripheral nerve block (e.g., femoral nerve block)
14. Current or planned use of neuraxial (epidural or intrathecal) opioids
15. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
16. History of suspected, or known, misuse, abuse, dependence of opioid analgesics, illicit drugs, prescription medicines, or alcohol within the past 2 years
17. Currently pregnant, nursing, or planning to become pregnant during the study
Clareo Health | Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
