- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02096393
Patient Specific Instrumentation in TKR
8. juni 2022 opdateret af: Sheffield Teaching Hospitals NHS Foundation Trust
A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation In Total Knee Arthroplasty
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery.
Patient specific instrumentation is an individualised system for total knee replacement surgery.
The system has been marketed and is already in use in some centres.
The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve.
This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery.
Patient specific instrumentation is an individualised system for total knee replacement surgery.
The system has been marketed and is already in use in some centres.
The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle.
From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy.
The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve.
This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
South Yorkshire
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Rotherham, South Yorkshire, Det Forenede Kongerige, S60 2UD
- Rotherham District General Hospitals NHS Trust
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Sheffield, South Yorkshire, Det Forenede Kongerige, S5 7AU
- Sheffield Teaching Hospital NHS Trust
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Males and females aged 18-75 years at time of surgery.
- Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
- Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- Patients who signed the study consent form prior to surgery.
Exclusion Criteria:
- Pregnant women.
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
- Muscle contracture around the knee joint
- Individuals with active or suspected infection or sepsis.
- Patients with contraindication to MRI
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Patient specific instrumentation
The patient will undergo using patient specific instrumentation
|
A custom made cutting block will be used during total knee replacement surgery.
The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery.
|
Aktiv komparator: Standard instrumentation
The patient will undergo surgery using standard instrumentation
|
Standard instrumentation will be used during total knee replacement surgery.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Implant alignment
Tidsramme: 6 weeks
|
Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Oxford Knee Score
Tidsramme: 1yr, 5yr, 10yr
|
Patient questionnaire
|
1yr, 5yr, 10yr
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
EUROQOL-5D
Tidsramme: 1 year, 5 years and 10 years
|
1 year, 5 years and 10 years
|
|
IKKS Score
Tidsramme: 1yr, 5 yr, 10yr
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Questionnaire
|
1yr, 5 yr, 10yr
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Caroline Blakey, MBChB, Sheffield Teaching Hospitals NHS Foundation Trust
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2013
Primær færdiggørelse (Faktiske)
18. juni 2020
Studieafslutning (Faktiske)
18. juni 2020
Datoer for studieregistrering
Først indsendt
7. marts 2014
Først indsendt, der opfyldte QC-kriterier
22. marts 2014
Først opslået (Skøn)
26. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STH16313
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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