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Digital Preop-planning of Total Hip Arthroplasties (PLANORTHO)

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ClinicalTrials.gov Identifier: NCT04090372
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Orthopedic Disorder Device: evaluation of pre-op planning using Traumacad Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Digital Preop-planning of Total Hip Arthroplasties in Orthopedic
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090372


Contacts
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Contact: Nicolas Reina, MD 05.61.77.55.78 ext 33 Reina.n@chu-toulouse.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, France, 31000
Contact: Nicolas Reina, MD    05.61.77.55.78 ext 33    Reina.n@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nicolas Reina, MD CHU de Toulouse, France

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04090372     History of Changes
Other Study ID Numbers: 14 7426 15
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Osteoarthritis
Hip
Total hip arthroplasty
leg discrepancy
preoperative planning
Additional relevant MeSH terms:
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Musculoskeletal Diseases