- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05038670
Journey II vs Persona Knee Systems - RCT
Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
Studieoversikt
Detaljert beskrivelse
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Mazovia
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Warsaw, Mazovia, Polen, 04-749
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Exclusion Criteria:
- Listed for a single-stage bilateral TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- Inflammatory arthritis
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- Patients on warfarin or novel oral anticoagulants (NOACs)
- Will not be resident in the catchment area for at least 6 months post-surgery
- Undertaking the surgery as a private patient
- Patients who, in the opinion of the clinical staff, do not have capacity to consent
- Patients who are pregnant
- Unable to understand written and spoken Polish
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: PERSONA
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
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Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
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Aktiv komparator: Journey II
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system
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Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
Tidsramme: baseline (preoperatively) and 1 year postoperatively
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To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis.
Results range from 0 to 100, with higher scores corresponding to better outcomes.
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baseline (preoperatively) and 1 year postoperatively
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Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
Tidsramme: baseline (preoperatively) and 1 year postoperatively
|
To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis.
Results range from 0 to 96, with higher scores corresponding to worse outcomes.
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baseline (preoperatively) and 1 year postoperatively
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Values of components rotation
Tidsramme: 1-day postoperatively
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Values of external or internal rotation of components measured in computed tomography postoperatively.
Values in degrees in regards to anatomic bone landmarks
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1-day postoperatively
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Artur Stolaerczyk, MD, PhD, Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WarsawMU/persona
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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