- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03912116
Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
16. december 2019 opdateret af: Tissue Tech Inc.
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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Orange Park, Florida, Forenede Stater, 32073
- Orange Park Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Amniotic Umbilical Cord Particulate Injection
100mg Amniotic Umbilical Cord Particulate in 8cc saline
|
Saltvand
100mg CLARIX FLO
|
Placebo komparator: Saline Injection
8cc saline
|
Saltvand
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in Pain at 2 weeks: visual analog scale
Tidsramme: 2 weeks
|
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
|
2 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in Pain at 5-7 days: visual analog scale
Tidsramme: 5-7 days
|
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
|
5-7 days
|
Difference in Patient Satisfaction: Questionnaire
Tidsramme: 2 weeks
|
Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied).
|
2 weeks
|
Difference in Quality of Life: SF-36
Tidsramme: 2 weeks
|
Assessed by SF-36 (0-100 scale with 100 representing no disability)
|
2 weeks
|
Difference in Subjective Outcome
Tidsramme: 2 weeks
|
Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)
|
2 weeks
|
Difference in pain medication consumption
Tidsramme: 2 weeks
|
opioid consumption (morphine equivalents)
|
2 weeks
|
Difference in range of motion between baseline and 2 weeks
Tidsramme: 2 weeks
|
degrees the knee joint can move
|
2 weeks
|
Length of Hospital Stay
Tidsramme: 5 days
|
5 days
|
|
Difference in Number of Readmissions
Tidsramme: 2 weeks
|
2 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. april 2019
Primær færdiggørelse (Faktiske)
16. december 2019
Studieafslutning (Faktiske)
16. december 2019
Datoer for studieregistrering
Først indsendt
9. april 2019
Først indsendt, der opfyldte QC-kriterier
10. april 2019
Først opslået (Faktiske)
11. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLARIX- CS007
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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