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Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03912116
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis: Joint Replacement Surgery Other: CLARIX FLO Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : July 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Amniotic Umbilical Cord Particulate Injection
100mg Amniotic Umbilical Cord Particulate in 8cc saline
Other: CLARIX FLO
100mg CLARIX FLO

Other: Saline
Saline

Placebo Comparator: Saline Injection
8cc saline
Other: Saline
Saline




Primary Outcome Measures :
  1. Difference in Pain at 2 weeks: visual analog scale [ Time Frame: 2 weeks ]
    Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)


Secondary Outcome Measures :
  1. Difference in Pain at 5-7 days: visual analog scale [ Time Frame: 5-7 days ]
    Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

  2. Difference in Patient Satisfaction: Questionnaire [ Time Frame: 2 weeks ]
    Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied).

  3. Difference in Quality of Life: SF-36 [ Time Frame: 2 weeks ]
    Assessed by SF-36 (0-100 scale with 100 representing no disability)

  4. Difference in Subjective Outcome [ Time Frame: 2 weeks ]
    Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)

  5. Difference in pain medication consumption [ Time Frame: 2 weeks ]
    opioid consumption (morphine equivalents)

  6. Difference in range of motion between baseline and 2 weeks [ Time Frame: 2 weeks ]
    degrees the knee joint can move

  7. Length of Hospital Stay [ Time Frame: 5 days ]
  8. Difference in Number of Readmissions [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912116


Contacts
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Contact: Sean Tighe 786-456-7699 stighe@tissuetechinc.com

Locations
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United States, Florida
Orange Park Medical Center Recruiting
Orange Park, Florida, United States, 32073
Contact: Burnette         
Sponsors and Collaborators
Tissue Tech Inc.

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Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT03912116     History of Changes
Other Study ID Numbers: CLARIX- CS007
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases