Digital Preop-planning of Total Hip Arthroplasties (PLANORTHO)

Digital Preop-planning of Total Hip Arthroplasties in Orthopedic

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Device: evaluation of pre-op planning using Traumacad

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Control group will be assessed by standard preop planning using implants templates.	Device: evaluation of pre-op planning using Traumacad; The study will be compare pre-op planning with standard condition or with TraumaCad
Active Comparator: TraumaCad Group; TraumaCad Group will be assessed by preop planning using Traumacad	Device: evaluation of pre-op planning using Traumacad; The study will be compare pre-op planning with standard condition or with TraumaCad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Nicolas Reina, MD, CHU de Toulouse, France

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Total hip arthroplasty; Hip; preoperative planning; leg discrepancy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 14 7426 15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No