Digital Preop-planning of Total Hip Arthroplasties

Orthopedic Disorder Clinical Trial

— PLANORTHO  

Official title:

Digital Preop-planning of Total Hip Arthroplasties in Orthopedic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090372
• Other study ID #: 14 7426 15
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Device:
• evaluation of pre-op planning using Traumacad
The study will be compare pre-op planning with standard condition or with TraumaCad

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative residual discrepancy	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.	day 3
Secondary	comparisons of the reproducibility of the femoral implants sizes	Secondary endpoints is comparisons of the reproducibility of the femoral implants sizes predicted by the software	day 3
Secondary	comparison of pelvis parameters	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	day 3