Arthroplasty, Bone Morphing, Knee Osteoarthritis
Conditions
Keywords
Lateral Distal Femur Angle (LDFA), Medial Proximal Tibial Angle (MPTA), Imageless navigation, Total Knee arthroplasty
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURENon-image-based Computer-Assisted Navigation with Bone Morphing
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.
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a prospective, single-group diagnostic accuracy study where each participant serves as their own control. For every patient, anatomical measurements (MPTA and LDFA) are obtained and compared using three different methods: Reference Standard: Preoperative 3D CT scan. Index Test A: Peroperative image-less navigation (bone morphing) performed on intact articular cartilage. Index Test B: Peroperative image-less navigation (bone morphing) performed after complete surgical removal of the cartilage. This intra-subject design allows for a direct comparison of the navigation system's fidelity against the gold-standard CT scan, while specifically isolating the impact of cartilage thickness on measurement accuracy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation. | At the time of surgery (intra-operative). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Lateral Distal Femoral Angle (LDFA) between CT scan and Imageless Navigation. | At the time of surgery (intraoperative) | 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. |
| Correlation of MPTA and LDFA measurements before and after cartilage removal. | At the time of surgery (intra-operative). | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAntoine MOUTON, Orthopedic surgeon
Diaconesses Croix Saint Simon Hospital Group
Outcome results
None listed