- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01475604
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty: A Double-Blind, Randomized, Sham-controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Surgeons are continually looking for means to minimize postoperative pain following TKA in order to reduce or eliminate the need for opioid pain medications. Reductions in pain and edema along with improvements in range of motion encourage quicker recovery of joint function and normal activities. Pulsed radio frequency (PRF), a type of electromagnetic field treatment is proven to effectively modulate postoperative pain and edema in plastic surgery. Therefore, PRF has potential as an adjunct therapy for patients recovering from TKA.
The purpose of the current double-blind, randomized, sham-controlled clinical trial is to determine the effectiveness and safety of the Ivivi Torino II, a device that delivers pulsed radio frequency (PRF), a type of electromagnetic field treatment, in patients recovering from TKA for treatment of severe knee OA.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Virginia
-
Alexandria, Virginia, États-Unis, 22306
- Anderson Orthopaedic Research Institute
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 40 to 80 years
- Primary diagnosis of knee OA
- Appropriate candidate for TKA
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study product and methods including follow-up
Exclusion Criteria:
- Body mass index > 40 kg/m2
- Scheduled for bilateral TKA
- Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
- Use of narcotic pain medication for any condition in the last 1 month prior to surgery
- Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)
- Pregnant or lactating female
- Participation in any clinical trial in the past 30 days
- Vulnerable populations including prisoners and nursing home residents
- Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur factice: Faux
|
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Autres noms:
Sham treatment for 4 weeks post-surgery
Autres noms:
|
Comparateur actif: Targeted pulsed electromagnetic field
|
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Autres noms:
Sham treatment for 4 weeks post-surgery
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
Délai: 2-week follow-up period from surgery
|
2-week follow-up period from surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
Délai: 1 and 4 weeks post-surgery
|
1 and 4 weeks post-surgery
|
|
Knee pain severity assessed on a 10 cm visual analogue scale (VAS)
Délai: At intervals over the 4-week follow-up period
|
Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation
|
At intervals over the 4-week follow-up period
|
The measurement of knee joint circumference
Délai: Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
|
With patient in supine position, the circumference of the extended knee will be measured 1 cm proximal to the base of the patella using the same type of tape measure in all patients
|
Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
|
Range of motion of the knee joint, assessed using the knee flexion technique
Délai: Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
|
Range of motion will be assessed using the knee flexion technique, which allows the use of a goniometer with the trans-epicondylar axis of the knee joint as the fulcrum.
|
Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
|
OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
Délai: 4 weeks post-surgery
|
Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.
|
4 weeks post-surgery
|
Adverse Events collected and analyzed for confirmation of device safety
Délai: Randomization to 4 weeks post-surgery
|
Subjects will be instructed by the research staff and in the instructions in the daily diary to contact the research staff and/or investigator with any adverse events (AEs).
Adverse events will be recorded daily.
|
Randomization to 4 weeks post-surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gerard A. Engh, M.D., Anderson Orthopaedic Research Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IOH-TKA-001
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Ivivi Torino II
-
Columbia UniversityComplétéAutre Chirurgie ReconstructiveÉtats-Unis
-
Center for Joint Surgery and Sports Medicine, MarylandInconnue
-
University of PittsburghRetiréDouleur postopératoire | Chirurgie de remodelage du corps abdominalÉtats-Unis
-
Amp Orthopedics, Inc.Résilié
-
Amp Orthopedics, Inc.Résilié
-
Columbia UniversityRésiliéSymptômes de l'épaule après la dissection des ganglions lymphatiquesÉtats-Unis
-
Sun Pharmaceutical Industries LimitedMoebius Medical Ltd.; Nordic Bioscience Clinical Development (NBCD)ComplétéArthrose du genouÉtats-Unis, Danemark, Hong Kong
-
Sohag UniversityRecrutement
-
Guidant CorporationSuspendu
-
St. Olavs HospitalSmith & Nephew, Inc.Pas encore de recrutementArthroplastie | Arthrite Genou | Analyse de la marcheNorvège