Digital Preop-planning of Total Hip Arthroplasties

Not Applicable

Completed

• Conditions: Orthopedic Disorder
• Interventions: Device: evaluation of pre-op planning using Traumacad

• Registration Number: NCT04090372
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

Detailed Description

Total hip arthroplasties (THAs) are used to restore locomotion. More than 150,000 THAs are performed each year in France. Better outcomes require a restoration of limb lengths and anatomy. Post-operative discrepancy is the main cause of complaints and financial compensation in the US after THA. As such, the investigators aim to use preoperative digital planning using TraumaCad to optimize the restoration of the center of rotation of the hips. Preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. The TraumaCad system (Brainlab®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Study Start: 2020-01-08
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• being older than18 years,
• osteoarthritis as the indication for THA

Exclusion Criteria

• THAs after femoral neck fractures,
• revision surgery,
• major architectural anomaly (Bone tumor, prior fracture of the pelvis, hip dysplasia),
• patients under legal protection,
• pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	evaluation of pre-op planning using Traumacad	Control group will be assessed by standard preop planning using implants templates.
TraumaCad Group	evaluation of pre-op planning using Traumacad	TraumaCad Group will be assessed by preop planning using Traumacad

Primary Outcome Measures

Name	Time	Method
postoperative residual discrepancy	day 3	The primary endpoint is the postoperative residual discrepancy measured on the radiographs on postop day 3 in millimeter compared using standard planning methods compared to TraumaCad.

Secondary Outcome Measures

Name	Time	Method
comparison of pelvis parameters	day 3	Secondary endpoints is the comparison of pelvis parameters in the 2 groups (offset, positioning of the implants) postoperatively. The angle of femur axis and the center of rotation of hip will be measure on the radiography of day 3
comparisons of the reproducibility of the femoral implants sizes	day 3	Secondary endpoints is comparisons of the reproducibility of the femoral implants sizes predicted by the software

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, France