Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Conditions
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Osteoarthritis: Joint Replacement Surgery

Intervention / Treatment
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* Other: CLARIX FLO
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amniotic Umbilical Cord Particulate Injection<br>100mg Amniotic Umbilical Cord Particulate in 8cc saline | Other: CLARIX FLO<br>* 100mg CLARIX FLO<br>Other: Saline<br>* Saline<br>|
| Placebo Comparator: Saline Injection<br>8cc saline | Other: Saline<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pain at 2 weeks: visual analog scale | Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pain at 5-7 days: visual analog scale | Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain) | 5-7 days | 
| Difference in Patient Satisfaction: Questionnaire | Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied). | 2 weeks | 
| Difference in Quality of Life: SF-36 | Assessed by SF-36 (0-100 scale with 100 representing no disability) | 2 weeks | 
| Difference in Subjective Outcome | Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms) | 2 weeks | 
| Difference in pain medication consumption | opioid consumption (morphine equivalents) | 2 weeks | 
| Difference in range of motion between baseline and 2 weeks | degrees the knee joint can move | 2 weeks | 
| Length of Hospital Stay |  | 5 days | 
| Difference in Number of Readmissions |  | 2 weeks |