- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05151315
Artroplastia total de rodilla NitrX RSA
Migración de componentes, desgaste de polietileno e inflamación articular del sistema de artroplastia total de rodilla Evolution Versus Evolution NitrX
Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. The Evolution® NitrX™ (MicroPort Orthopaedics, Memphis, TN) knee implant was designed with the addition of a coating meant to create a barrier against the release of metal ions. The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty surgery). This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays, called "radiostereometric analysis" (RSA for short). The investigators will also compare levels of circulating metal particles with blood draws and the effects of any circulating metal with MR imaging. The investigators will also be looking at the participants clinical outcomes using joint function and patient satisfaction questionnaires. A total of 50 patients will be enrolled into the study.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
London, Ontario, Canadá, N6A5A5
- London Health Sciences Centre
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Varus knee deformity of 0 to 10 degrees
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Between ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
- No contraindications to Magnetic Resonance Imaging (MRI)
Exclusion Criteria:
- Active or previous infection
- Medical condition precluding major surgery
- Inflammatory arthropathy
- Prior Patellectomy
- PCL deficiency
- Major Coronal plane deformity
- Valgus deformity
- Bone defects requiring augments, cones and/or stemmed implants
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Evolution Total Knee Arthroplasty system
Patients will undergo total knee arthroplasty with the Evolution Total Knee System |
Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty. |
|
Experimental: Evolution with NitrX Total Knee Arthroplasty system
Patients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating |
Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Implant Migration (Tibial Component)
Periodo de tiempo: 2 years
|
Model based Radiostereometric Analysis (RSA, specialized Xrays) will be used to register the location of the tibial implant components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential tibial migration, with the use of the tibial bone beads, will be measured in millimeters. |
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Implant Migration (Femoral Component)
Periodo de tiempo: 2 years
|
Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential femoral migration, with the use of the femoral bone beads, will be measured in millimeters. |
2 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Wear Rates
Periodo de tiempo: 2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years.
|
Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral and tibial components in both standing and supine exams where the minimum joint space width between components on the medial and lateral condyles can be calculated as a measurement (in millimeters) of polyethylene wear. |
2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years.
|
|
Circulating metal levels
Periodo de tiempo: Pre-operative, 1 and 2 years post-operatively.
|
Patients will have blood drawn and the levels of circulating cobalt, chromium, and nickel will be measured in whole blood. One vial of blood will be drawn from the patient (in milliliters). |
Pre-operative, 1 and 2 years post-operatively.
|
|
Synovial Joint Inflammation observation
Periodo de tiempo: 2 Years
|
Patients will complete an MRI exam using metal artefact reduction sequences. Scans will be evaluated and scored for synovial inflammation and fibrosis, indicative of reactions to metal debris, and the presence of fibrous tissue at the bone-cement-implant interface, indicative of component loosening. |
2 Years
|
|
Knee Injury and Osteoarthritis Outcome score (KOOS)
Periodo de tiempo: Pre-operative, 3 months, 1 year, and 2 year post-operative
|
Patient reported outcome measure. Holds 42 items that asks patient about pain, functional daily living, and sport and recreation. Questionnaire measures levels in frequency (never to always) and severity (none to extreme). Scores are from 0-100, with higher scores indicating no knee problems. |
Pre-operative, 3 months, 1 year, and 2 year post-operative
|
|
Forgotten Joint Score (FJS)
Periodo de tiempo: Pre-operative, 3 months, 1 year, and 2 year post-operative
|
Patient reported outcome measure observing the ability of a patient to forget about a joint due to successful treatment. Contains 12 items with frequency level measurement (never to mostly). The higher the score (0-100), the less aware the patient is of their affected joint when performing daily activity. |
Pre-operative, 3 months, 1 year, and 2 year post-operative
|
|
Veterans-Rand 12 Item Health Survey (VR-12)
Periodo de tiempo: Pre-operative, 3 months, 1 year, and 2 year post-operative
|
Patient reported outcome measure observing physical and mental health status of patient. Contains 14 items measuring levels of severity (excellent to poor) and frequency (None of the time to Yes, all of the time). Higher scores indicate higher quality of life and vice versa. |
Pre-operative, 3 months, 1 year, and 2 year post-operative
|
|
European Quality of Life - 5 Dimension (EQ-5D)
Periodo de tiempo: Pre-operative, 3 months, 1 year, and 2 year
|
Patient reported outcome measure. Standardized 5 item instrument measuring generic health status of patient. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated. Higher scores indicate higher health status of patient. |
Pre-operative, 3 months, 1 year, and 2 year
|
|
Metal Exposure/Sensitivity
Periodo de tiempo: Pre-operative
|
Patient reported outcome measure. Screening tool for noting pre-operative environmental metal exposures. Questionnaire contains Yes or No questions. Higher scores would indicate greater exposure and/or metal sensitivity. |
Pre-operative
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Edward M Vasarhelyi, MD, London Health Sciences Centre
- Investigador principal: Matthew Teeter, PhD, London Health Science Centre
Publicaciones y enlaces útiles
Publicaciones Generales
- Pijls BG, Plevier JWM, Nelissen RGHH. RSA migration of total knee replacements. Acta Orthop. 2018 Jun;89(3):320-328. doi: 10.1080/17453674.2018.1443635. Epub 2018 Mar 6.
- Teeter MG, Marsh JD, Howard JL, Yuan X, Vasarhelyi EM, McCalden RW, Naudie DDR. A randomized controlled trial investigating the value of patient-specific instrumentation for total knee arthroplasty in the Canadian healthcare system. Bone Joint J. 2019 May;101-B(5):565-572. doi: 10.1302/0301-620X.101B5.BJJ-2018-1323.R1.
- Teeter MG, Thoren J, Yuan X, McCalden RW, MacDonald SJ, Lanting BA, Naudie DD. Migration of a cemented fixed-bearing, polished titanium tibial baseplate (Genesis II) at ten years : a radiostereometric analysis. Bone Joint J. 2016 May;98-B(5):616-21. doi: 10.1302/0301-620X.98B5.36865.
- Teeter MG, Perry K, Yuan X, Howard JL, Lanting BA. The Effects of Resection Technique on Implant Migration in Single Radius Posterior-Stabilized Total Knee Replacement. J Knee Surg. 2020 Jan;33(1):78-83. doi: 10.1055/s-0038-1676462. Epub 2018 Dec 18.
- Sealed Envelope Ltd.2012.Power calculator for continuous outcome non0-inferiority trial.[Online] Available from: https://www.sealedenvelope.com/power/continuous-noninferios/[Accessed Thu Jan 14 2021].
- van Ijsseldijk EA, Valstar ER, Stoel BC, de Ridder R, Nelissen RG, Kaptein BL. Measuring polyethylene wear in total knee arthroplasty by RSA: differences between weight-bearing and non-weight-bearing positioning. J Orthop Res. 2014 Apr;32(4):613-7. doi: 10.1002/jor.22579. Epub 2014 Jan 7.
- Teeter MG, Wihlidal J, McCalden RW, Yuan X, MacDonald SJ, Lanting BA, Naudie DD. Radiostereometric Analysis Permits In Vivo Measurement of Very Small Levels of Wear in TKA. Clin Orthop Relat Res. 2019 Jan;477(1):80-90. doi: 10.1097/CORR.0000000000000399.
- Gascoyne T, Parashin S, Teeter M, Bohm E, Laende E, Dunbar M, Turgeon T. In vivo wear measurement in a modern total knee arthroplasty with model-based radiostereometric analysis. Bone Joint J. 2019 Nov;101-B(11):1348-1355. doi: 10.1302/0301-620X.101B11.BJJ-2018-1447.R2.
- Koff MF, Burge AJ, Potter HG. Clinical magnetic resonance imaging of arthroplasty at 1.5 T. J Orthop Res. 2020 Jul;38(7):1455-1464. doi: 10.1002/jor.24606. Epub 2020 Feb 4.
- Attard V, Li CY, Self A, Mann DA, Borthwick LA, O'Connor P, Deehan DJ, Kalson NS. Quantification of intra-articular fibrosis in patients with stiff knee arthroplasties using metal-reduction MRI. Bone Joint J. 2020 Oct;102-B(10):1331-1340. doi: 10.1302/0301-620X.102B10.BJJ-2020-0841.R1.
- Heyse TJ, Chong le R, Davis J, Boettner F, Haas SB, Potter HG. MRI analysis of the component-bone interface after TKA. Knee. 2012 Aug;19(4):290-4. doi: 10.1016/j.knee.2011.05.011. Epub 2011 Jul 8.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Osteoartritis
- Artrosis, Rodilla
- Procedimientos quirúrgicos, operativo
- Artroplastia, reemplazo
- Artroplastia
- Procedimientos ortopédicos
- Procedimientos de cirugía plástica
- Implantación de prótesis
- Artroplastia, reemplazo, rodilla
Otros números de identificación del estudio
- 119937
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .