Maxillo-Facial SurgeryNCT00240669
RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery
A study testing Resorbable device PLLA/PGA and Titanium device in people with Maxillo-Facial Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates. Secondary objective : To evaluate the resorbable device ergonomy versus Titanium. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Maxillo-Facial Surgery
- What is being tested?
- Resorbable device PLLA/PGA and Titanium device
- Type of treatment
- Medical device
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to not given
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18<Age<50.
- One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.
- One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.
- Orally and written informed patient. Patient willing to participate the study.
- Signed informed consent.
Who cannot join
- Any previous surgery at the same operative site.
- Patient suffering from chronic affection which could interfere with bone consolidation.
- Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.
- Nursing or pregnant female.
- Patient with a high risk of non compliance to sudy visits.
- Unconscious patient.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pierre Bouletreau
Lyon, 69495
Pierre BOULETREAU, MD, 33 4 78 86 19 36, pierre.bouletreau@chu-lyon.fr
About this study
Official title: RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy
Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.
Secondary objective :
Read more
- To evaluate the resorbable device ergonomy versus Titanium.
- To evaluate the clinical tolerance of resorbable device versus Titanium.
Hypothesis :
Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.
Study duration : 14 months for each patient.
Study treatment :
- Group I : Resorbable device PLLA/PGA.
- Group II : Titanium device.
Study visits :
- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.
Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.
- Conditions
- Maxillo-Facial Surgery
- Being tested
- Resorbable device PLLA/PGA, Titanium device
- Keywords
- Maxillo facial surgery,, osteosynthesis,, resorbable device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resorbable device PLLA/PGADevice
Titanium deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA will be evaluated by the notion of unperfect resuts.
Secondary outcomes (8)
Evaluation of device ergonomy :
The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.
Clinical tolerance of the devices
pain (Visual Analogic Scale),
local inflammation,
scar disunion,
infection,
subcutaneous or submucous palpation of the plates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillo-Facial SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 308 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Pierre BOULETREAU, MD, Principal investigator, Hospices Civile de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240669
- Sponsor's protocol ID
- 2004.366
- Status last verified
- Apr 2007
- First submitted
- 14 Oct 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy
- ClinicalTrials.gov ID
- NCT00240669
- Acronym / sponsor ID
- 2004.366
- Conditions
- Maxillo-Facial Surgery
- Keywords
- Maxillo facial surgery,, osteosynthesis,, resorbable device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2005
- First posted
- 18 Oct 2005 (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.
Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.
Secondary objective :
- To evaluate the resorbable device ergonomy versus Titanium.
- To evaluate the clinical tolerance of resorbable device versus Titanium.
Hypothesis :
Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.
Study duration : 14 months for each patient.
Study treatment :
- Group I : Resorbable device PLLA/PGA.
- Group II : Titanium device.
Study visits :
- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.
Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18<Age<50.
- One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.
- One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.
- Orally and written informed patient. Patient willing to participate the study.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Any previous surgery at the same operative site.
- Patient suffering from chronic affection which could interfere with bone consolidation.
- Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.
- Nursing or pregnant female.
- Patient with a high risk of non compliance to sudy visits.
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 |
|---|---|---|
| Resorbable device PLLA/PGA | Device | – |
| Titanium device | Device | – |
Primary outcome
The quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA will be evaluated by the notion of unperfect resuts.
8 secondary outcomes
Evaluation of device ergonomy :
The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.
Clinical tolerance of the devices
pain (Visual Analogic Scale),
local inflammation,
scar disunion,
infection,
subcutaneous or submucous palpation of the plates.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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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.
Pierre BOULETREAU, MD principal investigator
Hospices Civile de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resorbable device PLLA/PGA and Titanium device in people with Maxillo-Facial Surgery, run by Hospices Civils de Lyon 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre BOULETREAU, MD (33 4 78 86 19 36, pierre.bouletreau@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA will be evaluated by the notion of unperfect resuts.. 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 27 Apr 2007.