- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05151315
NitrX artroplastica totale del ginocchio RSA
Migrazione dei componenti, usura del polietilene e infiammazione articolare del sistema per artroplastica totale del ginocchio Evolution vs 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
London, Ontario, Canada, N6A5A5
- London Health Sciences Centre
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Implant Migration (Tibial Component)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Implant Migration (Femoral Component)
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Wear Rates
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Edward M Vasarhelyi, MD, London Health Sciences Centre
- Investigatore principale: Matthew Teeter, PhD, London Health Science Centre
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 119937
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .