Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis: Joint Replacement Surgery
• Intervention / Treatment: Other: Saline; Other: CLARIX FLO

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orange Park, Florida, United States, 32073
      • Orange Park Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic Umbilical Cord Particulate Injection; 100mg Amniotic Umbilical Cord Particulate in 8cc saline	Other: Saline; Saline; Other: CLARIX FLO; 100mg CLARIX FLO
Placebo Comparator: Saline Injection; 8cc saline	Other: Saline; Saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tissue Tech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CLARIX- CS007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No