Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Withdrawn before enrolling · Not applicable

Conditions studied: Osteoarthritis: Joint Replacement Surgery

In brief

Total knee arthroplasty (TKA) is the most common joint replacement surgery and its incidence is expected to increase 673% to 3.48 million procedures annually by 2030. After more than 20 years of follow-up data, TKA is confirmed to be an effective treatment for knee osteoarthritis, however, postoperative pain management continues to be a challenge despite advances in surgical techniques and anesthetic practice to minimize discomfort and enhance recovery. This acute post-surgical pain caused by extensive tissue damage and inflammation in TKA leads to restricted post-operative knee range of motion (ROM) and ability to mobilize.

Key facts

Study ID

NCT03912116

Run by

BioTissue Holdings, Inc

People needed

0

Starts

2019-04-09

Expected to finish

2019-12-16

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, greater than 18 years of age
• Primary diagnosis of unilateral osteoarthritis of the knee
• Scheduled to undergo primary, unilateral TKA
• ASA physical status 1, 2, or 3

You may not qualify if…

• 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
• Patient on chronic daily narcotic medication for knee pain based on medical history and Florida Prescription Drug Monitoring Program (E-FORCSE)
• Allergy or contraindication to any of the study medications
• Patient reported renal impairment based on medical history
• Bodyweight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
• History of previous fracture or open surgery on the knee being considered for TKA
• History of patellar instability, e.g., Valgus deformity
• History of inflammatory arthropathy (e.g., Rheumatoid arthritis, Lupus, etc.)
• 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
• Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might impact postsurgical pain or confound postsurgical assessments
• Planned use of intra-articular steroid injections during the study.
• Received any local anesthetic within 7 days of the planned TKA procedure aside from those part of the protocol
• Planned use of potent inhalational agents or peripheral nerve block (e.g., femoral nerve block)
• Current or planned use of neuraxial (epidural or intrathecal) opioids
• 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
• History of suspected, or known, misuse, abuse, dependence of opioid analgesics, illicit drugs, prescription medicines, or alcohol within the past 2 years
• Currently pregnant, nursing, or planning to become pregnant during the study

Where it is running

• Orange Park Medical Center — Orange Park, Florida, United States

Full record on ClinicalTrials.gov

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