Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Osteoarthritis: Joint Replacement Surgery Clinical Trial

Official title:

Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03912116
• Other study ID #: CLARIX- CS007
• Status: Withdrawn
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: December 2019
• Source: Tissue Tech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis: Joint Replacement Surgery

Intervention

Other:
• CLARIX FLO
100mg CLARIX FLO
• Saline
Saline

Locations

Country	Name	City	State
United States	Orange Park Medical Center	Orange Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Tech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Difference in Quality of Life: SF-36	Assessed by SF-36 (0-100 scale with 100 representing no disability)	2 weeks
Secondary	Difference in Subjective Outcome	Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)	2 weeks
Secondary	Difference in pain medication consumption	opioid consumption (morphine equivalents)	2 weeks
Secondary	Difference in range of motion between baseline and 2 weeks	degrees the knee joint can move	2 weeks
Secondary	Length of Hospital Stay		5 days
Secondary	Difference in Number of Readmissions		2 weeks