Calcaneus FractureNCT06234358
A Clinical Study Carried Out in Patients Operated With Calcanail®
An observational study of Calcaneus Fracture and Calcaneus Deformity of Foot, run by FH ORTHO at 1 site in France.
Trial summary
This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market. The primary objective of this study is to evaluate the safety of the device. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Calcaneus Fracture, Calcaneus Deformity of Foot, Arthrosis; Localized
- What is being tested?
- osteosynthesis
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2022to 1 Feb 2023
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
Who may be able to join
- Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
- Patient over 18 years old
- Patient who has received informed information and does not object to the collection of their data in this study.
Who cannot join
- Patient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device
This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.
The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.
This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.
84 patients will be included in the study.
Read the detailed description
The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.
- Being tested
- osteosynthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteosynthesisDevice
calcaneus osteosynthesis is a surgical fixation of a displaced fracture of the calcaneous bone. The surgery is performed under general or regional anesthesia. A scar is made on the lateral side of the ankle below the lateral malleolus. The bone fragments are repositioned as anatomically as possible. They are fixed by a percutaneous nailing fastener.
| Study group | Role | What they receive |
|---|---|---|
| Calcanail cohort | Patients implanted with medical device under study between January 2012 and January 2020. Receives: Device: osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate (revision)
This objective will be evaluated according to the revision rate in the study
Measured: 12 months
Secondary outcomes (3)
AOFAS score: American Orthopaedic Foot & Ankle Society Score
performance / 100 points represent an "excellent" result and the minimal score was 0
Measured: 12 months
Bone consolidation
Visible on X-ray after surgery
Measured: 4 months
Emergent adverse event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Aug 2022
- Primary completion1 Sep 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien LUCAS-HERNANDEZ, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234358
- Sponsor's protocol ID
- 2017-17
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device
- ClinicalTrials.gov ID
- NCT06234358
- Acronym / sponsor ID
- 2017-17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 31 Jan 2024 (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.
This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.
The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.
This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.
84 patients will be included in the study.
Detailed description
The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcanail cohort | – | Device: osteosynthesisPatients implanted with medical device under study between January 2012 and January 2020. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
Key inclusion criteria (3 listed)
- Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
- Patient over 18 years old
- Patient who has received informed information and does not object to the collection of their data in this study.
Key exclusion criteria (1 listed)
- Patient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.
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 |
|---|---|---|
| osteosynthesiscalcaneus osteosynthesis is a surgical fixation of a displaced fracture of the calcaneous bone. The surgery is performed under general or regional anesthesia. A scar is made on the lateral side of the ankle below the lateral malleolus. The bone fragments are repositioned as anatomically as possible. They are fixed by a percutaneous nailing fastener. | Device | Calcanail cohort |
Primary outcome
survival rate (revision)
Time frame: 12 months
This objective will be evaluated according to the revision rate in the study
3 secondary outcomes
AOFAS score: American Orthopaedic Foot & Ankle Society Score
Time frame: 12 months
Bone consolidation
Time frame: 4 months
Emergent adverse event
Time frame: 12 months
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 31 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Calcaneus Fracture
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Calcaneus Fracture
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Calcaneal Angles And Postoperative Body Balance Following Internal Fixation
Body Balnace and Calcaneal Fractures
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Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
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.
Julien LUCAS-HERNANDEZ, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcaneus Fracture and Calcaneus Deformity of Foot, run by FH ORTHO 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 3 inclusion and 1 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 31 Jan 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?
survival rate (revision) (time frame: 12 months). 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 31 Jan 2024.