Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Not Applicable

Withdrawn

• Conditions: Osteoarthritis: Joint Replacement Surgery
• Interventions: Other: CLARIX FLO; Other: Saline

• Registration Number: NCT03912116
• Lead Sponsor: Tissue Tech Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-09
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Status Verified: 2019-12
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotic Umbilical Cord Particulate Injection	CLARIX FLO	100mg Amniotic Umbilical Cord Particulate in 8cc saline
Amniotic Umbilical Cord Particulate Injection	Saline	100mg Amniotic Umbilical Cord Particulate in 8cc saline
Saline Injection	Saline	8cc saline

Primary Outcome Measures

Name	Time	Method
Difference in Pain at 2 weeks: visual analog scale	2 weeks	Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orange Park Medical Center; 🇺🇸 Orange Park, Florida, United States