Orthopedic DisorderPLANORTHONCT04090372
Digital Preop-planning of Total Hip Arthroplasties
A study testing evaluation of pre-op planning using Traumacad in people with Orthopedic Disorder, run by University Hospital, Toulouse at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- evaluation of pre-op planning using Traumacad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2020to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being older than18 years,
- osteoarthritis as the indication for THA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- evaluation of pre-op planning using Traumacad
- Keywords
- Osteoarthritis, Hip, Total hip arthroplasty, leg discrepancy, preoperative planning
- Medical subject headings
- Musculoskeletal Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of pre-op planning using TraumacadDevice
The study will be compare pre-op planning with standard condition or with TraumaCad
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group will be assessed by standard preop planning using implants templates. Receives: Device: evaluation of pre-op planning using Traumacad |
| TraumaCad Group | Active comparator | TraumaCad Group will be assessed by preop planning using Traumacad Receives: Device: evaluation of pre-op planning using Traumacad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 3
Secondary outcomes (2)
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
Measured: 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
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start8 Jan 2020
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Reina, MD, Principal investigator, CHU de Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090372
- Sponsor's protocol ID
- 14 7426 15
- Acronym
- PLANORTHO
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2019
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Preop-planning of Total Hip Arthroplasties in Orthopedic
- ClinicalTrials.gov ID
- NCT04090372
- Acronym / sponsor ID
- PLANORTHO / 14 7426 15
- Conditions
- Orthopedic Disorder
- Keywords
- Osteoarthritis, Hip, Total hip arthroplasty, leg discrepancy, preoperative planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: evaluation of pre-op planning using TraumacadControl group will be assessed by standard preop planning using implants templates. |
| TraumaCad Group | Active comparator | Device: evaluation of pre-op planning using TraumacadTraumaCad Group will be assessed by preop planning using Traumacad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being older than18 years,
- osteoarthritis as the indication for THA
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of pre-op planning using TraumacadThe study will be compare pre-op planning with standard condition or with TraumaCad | Device | Control group, TraumaCad Group |
Primary outcome
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.
2 secondary outcomes
comparisons of the reproducibility of the femoral implants sizes
Time frame: day 3
comparison of pelvis parameters
Time frame: day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Reina, MD principal investigator
CHU de Toulouse, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of pre-op planning using Traumacad in people with Orthopedic Disorder, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative residual discrepancy (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.