Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03912116
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tissue Tech Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis: Joint Replacement Surgery

Arms & Interventions

Arms

Experimental: Amniotic Umbilical Cord Particulate Injection

100mg Amniotic Umbilical Cord Particulate in 8cc saline

Placebo Comparator: Saline Injection

8cc saline

Interventions

Other: - CLARIX FLO

100mg CLARIX FLO

Other: - Saline

Saline

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orange Park Medical Center, Orange Park, Florida

Status

Recruiting

Address

Orange Park Medical Center

Orange Park, Florida, 32073

Site Contact

Burnette

[email protected]

786-456-7699

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