- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02448407
Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees
This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
- VAS greater than 5
- Between 40and 80 years of age
Exclusion Criteria:
- Level IV arthritis of the knee
- Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
- Frontal deformity greater than 10 degrees
- Ipsilateral pathology of the knee or ankle
- Range of motion or flexibility of the knee less than 90 degrees
- Deficit of knee extension greater than 15 degrees
- Anticoagulation treatment, antiplatelet treatment
- Hepatopathy
- Hematological neoplastic pathology
- Active infection
- Fibromyalgia
- Chronic fatigue syndrome
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Platelet rich plasma
Three intraarticular injection, one each fifteen days
|
Three intraarticular injections of platelet-rich plasma, one each fifteen days
Andre navn:
|
Aktiv komparator: Hyaluronic acid
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)
|
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes from baseline Visual Analogue Scale (VAS) value
Tidsramme: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
Tidsramme: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
KOOS is an instrument to assess the patient's opinion about their knee and associated problems.
It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
Effects on quality of life
Tidsramme: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
EUROQOL (European Quality of Life) for the evaluation of function and quality of life
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
All reported adverse events
Tidsramme: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Elvira Montañez Heredia, MD, PhD, Hospital Universitario Virgen de la Victoria. Málaga
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EMH-PRP-2013
- 2013-001303-36 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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