Osteoarthritis: Joint Replacement SurgeryNCT03912116
Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
A study testing CLARIX FLO and Saline in people with Osteoarthritis: Joint Replacement Surgery, run by BioTissue Holdings, Inc at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis: Joint Replacement Surgery
- What is being tested?
- CLARIX FLO and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 16 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange Park Medical Center
Orange Park, Florida, 32073
About this study
Official title: Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
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.
- Being tested
- CLARIX FLO, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLARIX FLOOther
100mg CLARIX FLO
SalineOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Umbilical Cord Particulate Injection | Experimental | 100mg Amniotic Umbilical Cord Particulate in 8cc saline Receives: Other: CLARIX FLO; Other: Saline |
| Saline Injection | Placebo comparator | 8cc saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pain at 2 weeks: visual analog scale
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
Measured: 2 weeks
Secondary outcomes (8)
Difference in Pain at 5-7 days: visual analog scale
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
Measured: 5-7 days
Difference in Patient Satisfaction: Questionnaire
Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied).
Measured: 2 weeks
Difference in Quality of Life: SF-36
Assessed by SF-36 (0-100 scale with 100 representing no disability)
Measured: 2 weeks
Difference in Subjective Outcome
Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)
Measured: 2 weeks
Difference in pain medication consumption
opioid consumption (morphine equivalents)
Measured: 2 weeks
Difference in range of motion between baseline and 2 weeks
degrees the knee joint can move
Measured: 2 weeks
Length of Hospital Stay
Measured: 5 days
Difference in Number of Readmissions
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start9 Apr 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Why it stopped: Personnel Changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis: Joint Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912116
- Sponsor's protocol ID
- CLARIX- CS007
- Status last verified
- Dec 2019
- First submitted
- 9 Apr 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03912116
- Acronym / sponsor ID
- CLARIX- CS007
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Personnel Changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic Umbilical Cord Particulate Injection | Experimental | Other: CLARIX FLO, Other: Saline100mg Amniotic Umbilical Cord Particulate in 8cc saline |
| Saline Injection | Placebo comparator | Other: Saline8cc saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLARIX FLO100mg CLARIX FLO | Other | Amniotic Umbilical Cord Particulate Injection |
| SalineSaline | Other | Amniotic Umbilical Cord Particulate Injection, Saline Injection |
Primary outcome
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)
8 secondary outcomes
Difference in Pain at 5-7 days: visual analog scale
Time frame: 5-7 days
Difference in Patient Satisfaction: Questionnaire
Time frame: 2 weeks
Difference in Quality of Life: SF-36
Time frame: 2 weeks
Difference in Subjective Outcome
Time frame: 2 weeks
Difference in pain medication consumption
Time frame: 2 weeks
Difference in range of motion between baseline and 2 weeks
Time frame: 2 weeks
Length of Hospital Stay
Time frame: 5 days
Difference in Number of Readmissions
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLARIX FLO and Saline in people with Osteoarthritis: Joint Replacement Surgery, run by BioTissue Holdings, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Pain at 2 weeks: visual analog scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.