Effekten af brugen af navigation i den justering, der opnås ved udførelse af en total knæarthroplastik hos overvægtige patienter
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Randomized, open and prospective clinical trial.
Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Madrid
-
Madrid, Madrid, Spanien, 28009
- Hospital Universitario Santa Cristina
-
Majadahonda, Madrid, Spanien, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Men and women over 18 years old.
- Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- Patient with a BMI equal to or greater than 30 Kg / m2
- Patients with clinical and radiological criteria of knee osteoarthritis.
- Patients with indication for primary TKA according to medical criteria.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to give informed consent in the absence of a legal representative.
- Subjects that are participating in a study with medicines or other medical devices.
- Those who show inability to follow the instructions or collaborate during the development of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
- Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
- Need a simultaneous bilateral TKA.
- Have a varus angle or valgus ≥ 15 °.
- Total revision knee arthroplasty.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Experimental
Total knee arthroplasty implanted with GPS navigation system. |
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment |
|
Aktiv komparator: Control
Total knee arthroplasty implanted with standard guides. |
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Deviation in a mechanical axis of knees
Tidsramme: 12 months
|
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º |
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiological axes (femoral)
Tidsramme: 12 months
|
Position angle of the femoral component: angle formed between the anatomical axis of the femur and the articular surface of the femoral component of the TKA (α). |
12 months
|
|
Radiological axes (tibial)
Tidsramme: 12 months
|
Position angle of the tibial component: angle formed between the anatomical axis of the tibia and the proximal surface of the tibial component of the TKA (β). |
12 months
|
|
Surgical procedure time
Tidsramme: Week 1
|
Surgical time |
Week 1
|
|
Admission (hospital) duration
Tidsramme: Week 1
|
Number of days of the hospital admission |
Week 1
|
|
Number of Surgical complications (Intraoperative)
Tidsramme: Week 1
|
Intraoperative complications |
Week 1
|
|
Number of Surgical complications (perioperative)
Tidsramme: 1 to 6 weeks
|
perioperative complications |
1 to 6 weeks
|
|
Number of Surgical complications (post-operative)
Tidsramme: 1-12 months
|
postoperative complications |
1-12 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Society Score Questionaire
Tidsramme: 6 weeks-12 months
|
KSS Questionaire, developed by the Knee Society, assesses the function of the knee replacement and the functional capabilities of patients after their implantation. It has to separate sections ("Knee Score" and "Functional Score") that are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. |
6 weeks-12 months
|
|
Range of Motion
Tidsramme: 6 weeks-12 months
|
The maximum extension and flexion |
6 weeks-12 months
|
|
Visual Analogic Scale for pain
Tidsramme: 1-12 months
|
VAS measure the intensity of the pain that the patient describes. It consists of a horizontal line of 10 centimeters, with 0cm being "no pain" and 10cm being "extreme pain". |
1-12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pedro José Torrijos Garrido, MD, PhD, Hospital Universitario Puerta de Hierro
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NAOBE
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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