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Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Primary Purpose

Osteoarthritis: Joint Replacement Surgery

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CLARIX FLO

Saline

About this trial

This is an interventional treatment trial for Osteoarthritis: Joint Replacement Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orange Park Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amniotic Umbilical Cord Particulate Injection

Saline Injection

Arm Description

100mg Amniotic Umbilical Cord Particulate in 8cc saline

8cc saline

Outcomes

Primary Outcome Measures

Difference in Pain at 2 weeks: visual analog scale

Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

Secondary Outcome Measures

Difference in Pain at 5-7 days: visual analog scale

Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

Difference in Patient Satisfaction: Questionnaire

Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied).

Difference in Quality of Life: SF-36

Assessed by SF-36 (0-100 scale with 100 representing no disability)

Difference in Subjective Outcome

Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)

Difference in pain medication consumption

opioid consumption (morphine equivalents)

Difference in range of motion between baseline and 2 weeks

degrees the knee joint can move

Length of Hospital Stay

Difference in Number of Readmissions

Full Information

NCT ID

NCT03912116

First Posted

April 9, 2019

Last Updated

December 16, 2019

Sponsor

Tissue Tech Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03912116

Brief Title

Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Official Title

Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Personnel Changes

Study Start Date

April 9, 2019 (Actual)

Primary Completion Date

December 16, 2019 (Actual)

Study Completion Date

December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tissue Tech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis: Joint Replacement Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amniotic Umbilical Cord Particulate Injection

Arm Type

Experimental

Arm Description

100mg Amniotic Umbilical Cord Particulate in 8cc saline

Arm Title

Saline Injection

Arm Type

Placebo Comparator

Arm Description

8cc saline

Intervention Type

Other

Intervention Name(s)

CLARIX FLO

Intervention Description

100mg CLARIX FLO

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

Saline

Primary Outcome Measure Information:

Title

Difference in Pain at 2 weeks: visual analog scale

Description

Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Difference in Pain at 5-7 days: visual analog scale

Description

Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

Time Frame

5-7 days

Title

Difference in Patient Satisfaction: Questionnaire

Description

Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied).

Time Frame

2 weeks

Title

Difference in Quality of Life: SF-36

Description

Assessed by SF-36 (0-100 scale with 100 representing no disability)

Time Frame

2 weeks

Title

Difference in Subjective Outcome

Description

Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)

Time Frame

2 weeks

Title

Difference in pain medication consumption

Description

opioid consumption (morphine equivalents)

Time Frame

2 weeks

Title

Difference in range of motion between baseline and 2 weeks

Description

degrees the knee joint can move

Time Frame

2 weeks

Title

Length of Hospital Stay

Time Frame

5 days

Title

Difference in Number of Readmissions

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Orange Park Medical Center

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

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