Is It Possible to Obtain Reliable MPTA and LDFA Values Using Imageless Navigation in Total Knee Arthroplasty? Comparison Between Preoperative CT Scan Measurements and Intraoperative Bone Morphing Before and After Articular Cartilage Removal (CAR-NAV-AL)
Is It Possible to Obtain Reliable MPTA and LDFA Values Using Imageless Navigation in Total Knee Arthroplasty? Comparison Between Preoperative CT Scan Measurements and Intraoperative Bone Morphing Before and After Articular Cartilage Removal.
Title: Evaluation of Image-less Navigation Accuracy in Total Knee Arthroplasty (CARNAVAL)
Summary:
The purpose of this study is to evaluate the accuracy of an imageless navigation system in measuring key anatomical angles (MPTA and LDFA) during Total Knee Arthroplasty (TKA). While preoperative CT scans are currently the gold standard for bone planning, imageless navigation uses a "bone morphing" technique during surgery to create a digital model of the knee.
The study aims to determine if the measurements obtained via bone morphing, both before and after cartilage removal, are consistent with the measurements obtained from preoperative CT scans. The investigators seek to confirm if imageless navigation can provide reliable anatomical data, potentially reducing the need for preoperative radiation and costs associated with CT imaging.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Background:
Accurate alignment is critical for the long-term success of Total Knee Arthroplasty (TKA). Newer robotic and navigated systems rely on bone morphing to define the patient's anatomy per-operatively. However, the impact of cartilage thickness and the intrinsic accuracy of these systems compared to 3D CT-based planning remain subjects of clinical interest.
Objectives:
The primary objective is to compare the Medial Proximal Tibial Angle (MPTA) and the Lateral Distal Femoral Angle (LDFA) measured by:
Preoperative CT scan (Reference standard).
Peroperative image-less navigation (bone morphing) with intact cartilage.
Peroperative image-less navigation (bone morphing) after cartilage removal.
Methodology:
This is a prospective, monocentric, interventional study. All included patients will undergo a standard preoperative 3D CT scan as part of the surgical planning. During the TKA procedure, the surgeon will use the navigation system to perform bone morphing at two specific stages:
Initial stage: On the joint surface with the cartilage still present.
Secondary stage: After the surgical removal of the articular cartilage.
Comparison:
The data collected peroperatively will be compared to the CT scan measurements. The study will evaluate the "fidelity" (accuracy) of the navigation system and analyze whether the presence or absence of cartilage significantly alters the reliability of the digital bone model created by the system.
Expected Outcomes:
The results will help determine the degree of confidence surgeons can place in imageless navigation for achieving precise anatomical alignment without the systematic use of preoperative 3D imaging.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Paris, Ranska, 75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
Patients aged 18 years or older.
Patients with primary or secondary knee osteoarthritis requiring a Total Knee Arthroplasty (TKA).
Patients for whom the surgical planning requires a pre-operative 3D CT scan.
Patients who have been informed about the study and have signed the written informed consent.
Patients affiliated with or beneficiaries of a social security scheme.
Exclusion Criteria:
Revision Total Knee Arthroplasty (re-operation).
Major bone loss or significant bone deformity that prevents reliable anatomical landmarking.
History of prior knee surgery that could interfere with the navigation system trackers (e.g., retained hardware in the femur or tibia).
Pregnant or breastfeeding women.
Persons deprived of liberty or under legal guardianship.
Patients with a known allergy to any component used during the standard surgical procedure.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Navigation and CT-scan Comparison Group)
All participants undergo Total Knee Arthroplasty (TKA) using an imageless navigation system.
Anatomical measurements (MPTA and LDFA) are recorded via bone morphing at two stages: 1) on intact articular cartilage and 2) after cartilage removal.
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Intraoperative surface morphing of the joint surfaces is performed to obtain LDFA and MPTA values.
The procedure compares measurements taken on the residual cartilage versus measurements taken directly on the osseous surface after cartilage debridement.
These values are then validated against preoperative 3D CT scan data.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation.
Aikaikkuna: At the time of surgery (intra-operative).
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The mean difference (measured in degrees) between the MPTA calculated from the preoperative 3D CT scan and the MPTA measured intraoperatively via bone morphing after cartilage removal.
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At the time of surgery (intra-operative).
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean Difference in Lateral Distal Femoral Angle (LDFA) between CT scan and Imageless Navigation.
Aikaikkuna: At the time of surgery (intraoperative)
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The mean difference (measured in degrees) between the LDFA calculated from the preoperative 3D CT scan and the LDFA measured intraoperatively via bone morphing after cartilage removal.
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At the time of surgery (intraoperative)
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Correlation of MPTA and LDFA measurements before and after cartilage removal.
Aikaikkuna: At the time of surgery (intra-operative).
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Evaluation of the measurement shift (in degrees) caused by the presence of articular cartilage during the bone morphing process.
This assesses the system's ability to extrapolate the subchondral bone surface.
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At the time of surgery (intra-operative).
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Antoine MOUTON, Orthopedic surgeon, Diaconesses Croix Saint Simon Hospital Group
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- MacDessi SJ, Griffiths-Jones W, Harris IA, Bellemans J, Chen DB. Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J. 2021 Feb;103-B(2):329-337. doi: 10.1302/0301-620X.103B2.BJJ-2020-1050.R1.
- Blakeney WG, Khan RJ, Wall SJ. Computer-assisted techniques versus conventional guides for component alignment in total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011 Aug 3;93(15):1377-84. doi: 10.2106/JBJS.I.01321.
- Rossi SMP, Sangaletti R, Perticarini L, Terragnoli F, Benazzo F. High accuracy of a new robotically assisted technique for total knee arthroplasty: an in vivo study. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):1153-1161. doi: 10.1007/s00167-021-06800-8. Epub 2022 Jan 4.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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