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Completed

NCT Number: NCT04090372

Digital Preop-planning of Total Hip Arthroplasties

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

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Key information

Conditions

Orthopedic Disorder Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Toulouse

Toulouse, 31000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

evaluation of pre-op planning using Traumacad

Device

The study will be compare pre-op planning with standard condition or with TraumaCad

Primary outcomes

  1. postoperative residual discrepancy

    Time frame: 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 outcomes

  1. comparisons of the reproducibility of the femoral implants sizes

    Time frame: day 3

    Secondary endpoints is comparisons of the reproducibility of the femoral implants sizes predicted by the software

  2. comparison of pelvis parameters

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Digital Preop-planning of Total Hip Arthroplasties in Orthopedic

Acronym: PLANORTHO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2019
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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