Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

NitrX total knearthroplasty RSA

Komponentmigrering, polyetylen-slitasje og leddbetennelse i Evolution Versus Evolution NitrX Total Knee Artroplasty System

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.

Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Implant Migration (Tibial Component)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Implant Migration (Femoral Component)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wear Rates
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Edward M Vasarhelyi, MD, London Health Sciences Centre
  • Hovedetterforsker: Matthew Teeter, PhD, London Health Science Centre

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2022

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

5. november 2021

Først innsendt som oppfylte QC-kriteriene

25. november 2021

Først lagt ut (Faktiske)

9. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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. .

Abonnere