Digital Preop-planning of Total Hip Arthroplasties (PLANORTHO)
Primary Purpose
Orthopedic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
evaluation of pre-op planning using Traumacad
Sponsored by
About this trial
This is an interventional treatment trial for Orthopedic Disorder focused on measuring Osteoarthritis, Hip, Total hip arthroplasty, leg discrepancy, preoperative planning
Eligibility 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
Sites / Locations
- CHU de ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
TraumaCad Group
Arm Description
Control group will be assessed by standard preop planning using implants templates.
TraumaCad Group will be assessed by preop planning using Traumacad
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04090372
First Posted
September 10, 2019
Last Updated
November 9, 2020
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04090372
Brief Title
Digital Preop-planning of Total Hip Arthroplasties
Acronym
PLANORTHO
Official Title
Digital Preop-planning of Total Hip Arthroplasties in Orthopedic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
Keywords
Osteoarthritis, Hip, Total hip arthroplasty, leg discrepancy, preoperative planning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group will be assessed by standard preop planning using implants templates.
Arm Title
TraumaCad Group
Arm Type
Active Comparator
Arm Description
TraumaCad Group will be assessed by preop planning using Traumacad
Intervention Type
Device
Intervention Name(s)
evaluation of pre-op planning using Traumacad
Intervention Description
The study will be compare pre-op planning with standard condition or with TraumaCad
Primary Outcome Measure Information:
Title
postoperative residual discrepancy
Description
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.
Time Frame
day 3
Secondary Outcome Measure Information:
Title
comparisons of the reproducibility of the femoral implants sizes
Description
Secondary endpoints is comparisons of the reproducibility of the femoral implants sizes predicted by the software
Time Frame
day 3
Title
comparison of pelvis parameters
Description
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
Time Frame
day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Reina, MD
Phone
05.61.77.55.78
Ext
33
Email
Reina.n@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Reina, MD
Organizational Affiliation
CHU de Toulouse, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Reina, MD
Phone
05.61.77.55.78
Ext
33
Email
Reina.n@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Preop-planning of Total Hip Arthroplasties
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