- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02500160
Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.
14. juli 2015 oppdatert av: KANG-IL KIM, Kyung Hee University Hospital at Gangdong
Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA) as a new technology for improving accuracy in restoration of the alignment and biomechanics of the lower limb.
PSI in TKA refers to custom-made cutting jigs manufactured according to the patient's anatomic configuration of distal femur and proximal tibia based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans.
MRI- and CT-based PSI systems are available from various manufacturers for preoperative planning.
MRI offers precise visualization of articular cartilage without the risk of radiation exposure, but it is expensive and requires long scan times.
In contrast, CT enables accurate identification of the contour of the femur and tibia at short scan times, but it does not provide information on the cartilage thickness and carries the risk of radiation exposure.
As a result, there is a possibility of some discrepancy between the thickness of bone resection proposed by MRI- or CT-based PSI system and the actual thickness of bone cut.
Although PSI has been the focus of study in many recent researches, there has been no clinical study comparing MRI-based and CT-based PSI systems in preoperative planning.
Therefore the investigators questioned whether the MRI-based PSI that reflects the cartilage layer would provide more precision in TKA than the CT-based PSI.
The purpose of this study was to investigate the accuracy of MRI-based PSI and CT-based PSI in predicting bone resection thickness in TKA.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 134-090
- Kyung Hee University Hospital at Gangdong
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Of the patients who had been scheduled for TKA for the treatment of primary osteoarthritis only with varus deformity, those who had been waiting 6 weeks for TKA using an MRI-based or CT-based PSI system and had consented to the relatively new technique were enrolled in the study.
Exclusion Criteria:
- Patients with primary osteoarthritis with valgus deformity, rheumatoid arthritis, hemophilic arthritis, posttraumatic arthritis, other inflammatory arthritis, or a history of previous high tibial osteotomy were excluded from the study.
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 |
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Eksperimentell: patient specific instrumentation (MRI)
MRI based patient-specific instrumentation
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Aktiv komparator: patient specific instrumentation (CT)
CT based patient-specific instrumentation
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.
Tidsramme: intraoperative time
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After bone resection using a patient-specific cutting jig, the actual thickness of resected bone was measured in 0.1 mm increments by the Vernier caliper (B.Braun-Aesculap, Tuttlingen, Germany) and compared with the planned resection thickness preoperatively using the PSI program.In the MRI group, the intraoperative cutting thickness was compared directly with the preoperatively planned thickness, whereas the presumed thickness of cartilage (2 mm) was added to actual thickness of resected bone from the lateral condyles in the CT group.
Finally, the thickness of saw blade (1.27-mm) was added to every resected bone in all cases.
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intraoperative time
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
radiographic assessment
Tidsramme: postoperative 6 weeks
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The mechanical axis (MA) of the lower extremity and the coronal and sagittal alignments of the femoral and tibial components were measured on the anterior and lateral weight-bearing radiographs of the knee and the lower extremity orthogram before the surgery and 6 weeks after the surgery.
The measurements were performed using a picture-acquiring communication system (PACS, Infinitt Healthcare, Seoul, Korea), and the data were recorded to one decimal place.
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postoperative 6 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Kang-Il Kim, MD,PhD, Kyung Hee University Hospital at Gangdong
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
1. februar 2011
Primær fullføring (Faktiske)
1. september 2012
Datoer for studieregistrering
Først innsendt
13. juli 2015
Først innsendt som oppfylte QC-kriteriene
14. juli 2015
Først lagt ut (Anslag)
16. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juli 2015
Sist bekreftet
1. juli 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KHNMC 2011-058
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. .
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