An interventional study of Non-image-based Computer-Assisted Navigation with Bone Morphing in Arthroplasty, Bone Morphing and Knee Osteoarthritis, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon · Not applicable, Interventional, and Health services research
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.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Groupe Hospitalier Diaconesses Croix Saint-Simon is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Procedure: Non-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.
Mean Difference in Medial Proximal Tibial Angle (MPTA) between CT scan and Imageless Navigation.
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.
Time frame: At the time of surgery (intra-operative).
Mean Difference in Lateral Distal Femoral Angle (LDFA) between CT scan and Imageless Navigation.
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.
Time frame: At the time of surgery (intraoperative)
Correlation of MPTA and LDFA measurements before and after cartilage removal.
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.
Time frame: At the time of surgery (intra-operative).
Plan to share: No
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Groupe Hospitalier Diaconesses Croix Saint-Simon