[Studio clinico di un dispositivo non approvato o autorizzato dalla FDA statunitense]
[Studio del dispositivo non approvato o autorizzato dalla FDA statunitense]
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.
Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.
At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.
The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kristie Kennedy, MA
- Numero di telefono: 312-695-4023
- Email: kristie.kennedy@northwestern.edu
Backup dei contatti dello studio
- Nome: Robert Lewandowski, MD
- Numero di telefono: 312-695-9121
- Email: r-lewandowki@northwestern.edu
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Reclutamento
- Northwestern University
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Contatto:
- Robert Lewandowski, MD
- Numero di telefono: 312-695-9121
- Email: r-lewandowski@northwestern.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Age 40-80 years
- Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
- Self-reported pain of at least 5/10 VAS questionnaire
- Failure of conservative therapy, such as pain medications, for at least 3 months
- Patient must understand and sign the informed consent
- Patient can comply with the proposed follow-up schedule
- Patient can follow the post-operative management
Exclusion Criteria:
- History of rheumatoid arthritis
- Renal insufficiency precluding angiography (GFR < 50 mL/min)
- Irreversible coagulopathy
- Previous knee arthroplasty on the intended knee
- Existing knee joint infection
- Kellgren-Lawrence grade 1 or 4
- Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses
- Life expectancy < 6 months
- Infectious arthritis
- Allergy to iodinated contrast resulting in anaphylaxis
- Pregnant or interested in becoming pregnant three months from the date of the GAE procedure
- Involved in litigation or worker's compensation claims
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: GAE Procedure
All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees.
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Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee.
Tiny particles are then injected through the catheter into these arteries, reducing the blood supply.
These small particles are considered a medical device called Embosphere Microspheres.
These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations.
The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient safety endpoints
Lasso di tempo: Screening/baseline, 1, 3, and 6 months
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Primary safety endpoints include: 1. Incidence and severity of adverse events (AEs). These include:
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Screening/baseline, 1, 3, and 6 months
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Objective clinical endpoints - Cone beam computed tomography
Lasso di tempo: Immediately pre-and post-embolization
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Change in enhancement on cone beam computed tomography (CT)
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Immediately pre-and post-embolization
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Objective clinical endpoints - VAS
Lasso di tempo: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Change in Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain).
Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome
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Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Objective clinical endpoints - WOMAC
Lasso di tempo: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis.
Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
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Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Preliminary Effectiveness - WOMAC
Lasso di tempo: Screening/baseline, 1, 3, 6, and 12 months
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Secondary endpoint will be evaluated based on existing validated pain scoring systems.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis will be utilized.
Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
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Screening/baseline, 1, 3, 6, and 12 months
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Preliminary Effectiveness - VAS
Lasso di tempo: Screening/baseline, 1, 3, 6, and 12 months
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Secondary endpoint will be evaluated based on existing validated pain scoring systems.
The Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain) will be utilized.
Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome.
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Screening/baseline, 1, 3, 6, and 12 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Robert Lewandowski, MD, Northwestern University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STU00223591
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Prove cliniche su Embosphere Microspheres
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University of NebraskaInCor Heart Institute; VU University of AmsterdamCompletatoDolore al petto | STEMIOlanda, Brasile