Infection of Total Hip Joint ProsthesisORTHOPLANNCT02842684
Orthopedic Digital Planning for Total Hip Arthroplasties
A study testing TraumaCad software in people with Infection of Total Hip Joint Prosthesis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection of Total Hip Joint Prosthesis
- What is being tested?
- TraumaCad software
- 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
- 1 Oct 2019to 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
- Inclusion concerns all major patients able supported for osteoarthritis for the realization of a primary hip replacement .
Who cannot join
- Minor patients
- BMI greater than 35 patients
- Recovery or major architectural disorder surgery ( preoperative upper inequality 2 cm or dysplastic hip)
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have developed this technology and is part of the routine assessment of hip prothesis pre and postoperatively.
The TraumaCad software can superimpose implants on Picture Archiving and Communication System and evaluate digital and reproducible size of the implants and their correct position .
This is to demonstrate the superiority of modern digital tools in the preoperative preparation in Orthopaedics set.
Read the detailed description
Modern joint replacements in orthopedic surgery allow to restore locomotion. More than 150,000 hip replacements are performed each year in France . The optimization results going restoration of the lengths of members and anatomy .
Preoperative planning of hip replacements optimizes the return of the hip rotation center . Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise . The recent TraumaCad system ( Brainlab® ) allows adjustment of the scales for each patient and the virtual positioning of implants to simulate the response to the return of geometric parameters of the hip.
Preoperative planning by TraumaCad hip arthroplasties provides better restitution of limb length over conventional planning methods.
The standardized radiographs being the investigators want to compare this group with a control group operated without TraumaCad planning and evaluating the accuracy of the software to predict implants sizes also .
There is no risk to the patient with this procedure . The direct benefit is increased accuracy of surgical gesture to the patient and the reduction of mechanical problems related to leg length . Earnings for the orthopedic community is the postoperative evaluation. In the long term , the prosthetic technical improvement must increase the life of prostheses with therefore lower revisions and less expenditure in terms of public health.
The widespread use of automated planning and objective assessment postoperative radiographs .
- Conditions
- Infection of Total Hip Joint Prosthesis
- Being tested
- TraumaCad software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraumaCad softwareDevice
restitution of anatomical- radiological parameters after total hip arthroplasty with TraumaCad , conventional planning systems and without planning.
| Study group | Role | What they receive |
|---|---|---|
| Traumacad software | Experimental | Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise . The recent TraumaCad system ( Brainlab® ) allows adjustment of the scales for each patient and the virtual positioning of implants to simulate the response to the return of geometric hip parameters Receives: Device: TraumaCad software |
| without digital planning | No intervention | Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative inequality measured on the radiograph the 3rd postoperative day.
postoperative inequality measured on the radiograph the 3rd postoperative day.
Measured: day 3 after chirurgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start1 Oct 2019
- 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 Infection of Total Hip Joint ProsthesisStudies 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, Dr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842684
- Sponsor's protocol ID
- RC31/14/7426
- Acronym
- ORTHOPLAN
- Status last verified
- Jun 2024
- First submitted
- 20 Jul 2016
- Last updated
- 12 Jun 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopedic Digital Planning for Total Hip Arthroplasties
- ClinicalTrials.gov ID
- NCT02842684
- Acronym / sponsor ID
- ORTHOPLAN / RC31/14/7426
- Conditions
- Infection of Total Hip Joint Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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.
Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have developed this technology and is part of the routine assessment of hip prothesis pre and postoperatively.
The TraumaCad software can superimpose implants on Picture Archiving and Communication System and evaluate digital and reproducible size of the implants and their correct position .
This is to demonstrate the superiority of modern digital tools in the preoperative preparation in Orthopaedics set.
Detailed description
Modern joint replacements in orthopedic surgery allow to restore locomotion. More than 150,000 hip replacements are performed each year in France . The optimization results going restoration of the lengths of members and anatomy .
Preoperative planning of hip replacements optimizes the return of the hip rotation center . Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise . The recent TraumaCad system ( Brainlab® ) allows adjustment of the scales for each patient and the virtual positioning of implants to simulate the response to the return of geometric parameters of the hip.
Preoperative planning by TraumaCad hip arthroplasties provides better restitution of limb length over conventional planning methods.
The standardized radiographs being the investigators want to compare this group with a control group operated without TraumaCad planning and evaluating the accuracy of the software to predict implants sizes also .
There is no risk to the patient with this procedure . The direct benefit is increased accuracy of surgical gesture to the patient and the reduction of mechanical problems related to leg length . Earnings for the orthopedic community is the postoperative evaluation. In the long term , the prosthetic technical improvement must increase the life of prostheses with therefore lower revisions and less expenditure in terms of public health.
The widespread use of automated planning and objective assessment postoperative radiographs .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumacad software | Experimental | Device: TraumaCad softwarePreoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise . The recent TraumaCad system ( Brainlab® ) allows adjustment of the scales for each patient and the virtual positioning of implants to simulate the response to the return of geometric hip parameters |
| without digital planning | No intervention | –Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion concerns all major patients able supported for osteoarthritis for the realization of a primary hip replacement .
Key exclusion criteria (3 listed)
- Minor patients
- BMI greater than 35 patients
- Recovery or major architectural disorder surgery ( preoperative upper inequality 2 cm or dysplastic hip)
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 |
|---|---|---|
| TraumaCad softwarerestitution of anatomical- radiological parameters after total hip arthroplasty with TraumaCad , conventional planning systems and without planning. | Device | Traumacad software |
Primary outcome
postoperative inequality measured on the radiograph the 3rd postoperative day.
Time frame: day 3 after chirurgical intervention
postoperative inequality measured on the radiograph the 3rd postoperative day.
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 12 Jun 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, Dr principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TraumaCad software in people with Infection of Total Hip Joint Prosthesis, 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 1 inclusion and 3 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 12 Jun 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 inequality measured on the radiograph the 3rd postoperative day. (time frame: day 3 after chirurgical intervention). 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 12 Jun 2024.