Bones, TumorsSTOICNCT02683590
STernectOmy Repair Efficiency of a Ceramic Implant
A study testing Ceramic Implant in people with Bones, Tumors, run by University Hospital, Limoges at 3 sites in France.
Trial summary
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bones, Tumors
- What is being tested?
- Ceramic Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2016to Aug 2019
- 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
- Patient major
- Having a replacement indicating the sternum (or a part of the sternum)
- With an expected life of over one year, estimated by the principal investigator
- Written consent of the patient
Who cannot join
- People under safeguard justice,
- Patient under guardianship,
- Patient pregnant or breastfeeding,
- Topic attending another search including a period of exclusion still going to run-in
- Contraindication to general anesthesia
- Of alumina allergy antecedent
- Recent infectious disease unsupported
- BMI> 40
Trial locations and contacts
3 sites in 1 country.
France3 sites
Limoges Hospital
Limoges, 87 042
Saint George clinic
Nice
Reims university hospital
Reims
About this study
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.
Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.
- Conditions
- Bones, Tumors
- Being tested
- Ceramic Implant
- Keywords
- Sternectomie, Ceramic Implant, Bones Tumors
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic ImplantDevice
The replacement of the sternum by a ceramic implant
| Study group | Role | What they receive |
|---|---|---|
| sternum by a ceramic implant | Experimental | The replacement of the sternum by a ceramic implant Receives: Device: Ceramic Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital capacity
Slow Vital Capacity (liters), forced vital capacity (liters)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bones, TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683590
- Sponsor's protocol ID
- I15032
- Acronym
- STOIC
- Status last verified
- Jan 2017
- First submitted
- 2 Feb 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STernectOmy Repair Efficiency of a Ceramic Implant
- ClinicalTrials.gov ID
- NCT02683590
- Acronym / sponsor ID
- STOIC / I15032
- Conditions
- Bones, Tumors
- Keywords
- Sternectomie, Ceramic Implant, Bones Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 17 Feb 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.
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.
Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sternum by a ceramic implant | Experimental | Device: Ceramic ImplantThe replacement of the sternum by a ceramic implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient major
- Having a replacement indicating the sternum (or a part of the sternum)
- With an expected life of over one year, estimated by the principal investigator
- Written consent of the patient
Key exclusion criteria (8 listed)
- People under safeguard justice,
- Patient under guardianship,
- Patient pregnant or breastfeeding,
- Topic attending another search including a period of exclusion still going to run-in
- Contraindication to general anesthesia
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 |
|---|---|---|
| Ceramic ImplantThe replacement of the sternum by a ceramic implant | Device | sternum by a ceramic implant |
Primary outcome
vital capacity
Time frame: 1 day
Slow Vital Capacity (liters), forced vital capacity (liters)
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 Aug 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic Implant in people with Bones, Tumors, run by University Hospital, Limoges at 3 sites 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 4 inclusion and 8 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
vital capacity (time frame: 1 day). 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 Aug 2019.