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WithdrawnNCT03912116Updated Dec 18, 2019

Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

An interventional study of CLARIX FLO and Saline in Osteoarthritis: Joint Replacement Surgery, sponsored by BioTissue Holdings, Inc. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by BioTissue Holdings, Inc · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Personnel Changes
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis: Joint Replacement Surgery

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

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Lead sponsor

BioTissue Holdings, Inc is the lead sponsor of 14 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Amniotic Umbilical Cord Particulate Injection

    100mg Amniotic Umbilical Cord Particulate in 8cc saline

    Other: CLARIX FLO · Other: Saline

  • Placebo comparator
    Saline Injection

    8cc saline

    Other: Saline

Interventions

  • OtherCLARIX FLO

    100mg CLARIX FLO

  • OtherSaline

    Saline

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What researchers measure

Primary outcomes

  1. Difference in Pain at 2 weeks: visual analog scale

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

    Time frame: 2 weeks

Secondary outcomes

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

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

    Time frame: 5-7 days

  2. Difference in Patient Satisfaction: Questionnaire

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

    Time frame: 2 weeks

  3. Difference in Quality of Life: SF-36

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

    Time frame: 2 weeks

  4. Difference in Subjective Outcome

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

    Time frame: 2 weeks

  5. Difference in pain medication consumption

    opioid consumption (morphine equivalents)

    Time frame: 2 weeks

  6. Difference in range of motion between baseline and 2 weeks

    degrees the knee joint can move

    Time frame: 2 weeks

  7. Length of Hospital Stay

    Time frame: 5 days

  8. Difference in Number of Readmissions

    Time frame: 2 weeks

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Study locations

1 site
  • Orange Park Medical Center
    Orange Park, Florida 32073, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03912116
Lead sponsor
BioTissue Holdings, Inc
Responsible party
Sponsor
First posted
Apr 11, 2019
Start date
Apr 9, 2019
Primary completion
Dec 16, 2019
Completion
Dec 16, 2019
Last update
Dec 18, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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