Brittle Bone DiseaseFassier-DuvalNCT02868294
Preventive Fixation of Lower Limbs in Osteogenesis Imperfecta (Brittle Bone Disease) With the Highlight of the Fassier-Duval
A study testing Fassier-Duval Nail in people with Brittle Bone Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1 in 10000 at 20000. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Brittle Bone Disease
- What is being tested?
- Fassier-Duval Nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Aug 2017
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Minor Patient, male or female patients with osteogenesis imperfecta
- Patients who were operated on for intramedullary nailing of the femur or tibia by a nail-Bailey Dubow or sliding nailing between 1996 and 2010
- Patients with surgical management of the disease was performed in the orthopedic surgery department of the Assistance Publique Hôpitaux de Marseille
Who cannot join
- Non patients with osteogenesis imperfecta
- Major patients
- Patients who have never had nailing of the femur or tibia by a nail-Bailey Dubow or sliding nailing
Trial locations and contacts
1 site in 1 country.
Franck LAUNAY, PU-PH contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Urielle DESALBRES, Director, drci@ap-hm.fr
Franck LAUNAY, PU-PH
About this study
Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1 in 10000 at 20000. There are many forms of osteogenesis imperfecta to classify patients with symptomatology minor to the patients with lethal form during the neonatal period. The main symptoms are dominated by fractures and bone deformities, particularly in the lower limbs. Bisphosphonate medication is used for over 10 years to reduce the number of fractures. However the long-term effects are not known to date, not allowing even to establish proof of the benefit risk. Thus unable to process all of these patients and over a long time, these drug treatment leaves much therapeutic solutions to surgery. The goal of surgery is to treat fractures, treat bone deformities and prevent fractures future. In the long bones of the limbs, the only effective techniques are intramedullary nailing. The majority of realized nailing nailing are either sliding or telescopic enabling having a reinforced bone of an intramedullary osteosynthesis material over its entire length during the period of bone growth. It has been shown that the technique of the sliding nailing was inexpensive but reliable especially before the age of 5 years. After that age, all are telescopic nailing nailing. The first telescopic nail described is the Bailey-Dubow nail still widely used in France. However, the number of complications relating to its use is important. Thus, there are 8% of disunity equipment and 33 to 72% of the nail migration forcing him to change one or more times during growth. A new nail presented at the French orthopedic company in 2005 and Fassier Duval reported a much lower complication rate because the rate of nail migration is only 9%, without opening the knee joint, which is not possible with the highlight of Bailey-Dubow.
It is proposed to conduct a prospective series of 10 nailing the lower extremities with this nail Fassier-Duval in patients with osteogenesis imperfecta and compare the results with a series of patients already treated with Bailey-Dubow nails in order to highlight the advantages and disadvantages of using of such a nail.
- Conditions
- Brittle Bone Disease
- Being tested
- Fassier-Duval Nail
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fassier-Duval NailDevice
Implementation of a telescopic system intramedullary
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving the Fassier-Duval Nail | Experimental | Implementation of a telescopic system intramedullary Receives: Device: Fassier-Duval Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment by radiography intraosseous migration rate
Measure the distance between the end of a nail with the visible boundaries of the epiphysis and the growth of cartilage.
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2011
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brittle Bone DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck LAUNAY, PU-PH, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868294
- Sponsor's protocol ID
- 2011-06
- Other IDs
- 2011-A00437-34, RC12_3016
- Acronym
- Fassier-Duval
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Fixation of Lower Limbs in Osteogenesis Imperfecta (Brittle Bone Disease) With the Highlight of the Fassier-Duval
- ClinicalTrials.gov ID
- NCT02868294
- Acronym / sponsor ID
- Fassier-Duval / 2011-06
- Conditions
- Brittle Bone Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Aug 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.
Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1 in 10000 at 20000. There are many forms of osteogenesis imperfecta to classify patients with symptomatology minor to the patients with lethal form during the neonatal period. The main symptoms are dominated by fractures and bone deformities, particularly in the lower limbs. Bisphosphonate medication is used for over 10 years to reduce the number of fractures. However the long-term effects are not known to date, not allowing even to establish proof of the benefit risk. Thus unable to process all of these patients and over a long time, these drug treatment leaves much therapeutic solutions to surgery. The goal of surgery is to treat fractures, treat bone deformities and prevent fractures future. In the long bones of the limbs, the only effective techniques are intramedullary nailing. The majority of realized nailing nailing are either sliding or telescopic enabling having a reinforced bone of an intramedullary osteosynthesis material over its entire length during the period of bone growth. It has been shown that the technique of the sliding nailing was inexpensive but reliable especially before the age of 5 years. After that age, all are telescopic nailing nailing. The first telescopic nail described is the Bailey-Dubow nail still widely used in France. However, the number of complications relating to its use is important. Thus, there are 8% of disunity equipment and 33 to 72% of the nail migration forcing him to change one or more times during growth. A new nail presented at the French orthopedic company in 2005 and Fassier Duval reported a much lower complication rate because the rate of nail migration is only 9%, without opening the knee joint, which is not possible with the highlight of Bailey-Dubow.
It is proposed to conduct a prospective series of 10 nailing the lower extremities with this nail Fassier-Duval in patients with osteogenesis imperfecta and compare the results with a series of patients already treated with Bailey-Dubow nails in order to highlight the advantages and disadvantages of using of such a nail.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving the Fassier-Duval Nail | Experimental | Device: Fassier-Duval NailImplementation of a telescopic system intramedullary |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Minor Patient, male or female patients with osteogenesis imperfecta
- Patients who were operated on for intramedullary nailing of the femur or tibia by a nail-Bailey Dubow or sliding nailing between 1996 and 2010
- Patients with surgical management of the disease was performed in the orthopedic surgery department of the Assistance Publique Hôpitaux de Marseille
Key exclusion criteria (3 listed)
- Non patients with osteogenesis imperfecta
- Major patients
- Patients who have never had nailing of the femur or tibia by a nail-Bailey Dubow or sliding nailing
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 |
|---|---|---|
| Fassier-Duval NailImplementation of a telescopic system intramedullary | Device | Patient receiving the Fassier-Duval Nail |
Primary outcome
Assessment by radiography intraosseous migration rate
Time frame: 72 months
Measure the distance between the end of a nail with the visible boundaries of the epiphysis and the growth of cartilage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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.
Franck LAUNAY, PU-PH contact
Franck LAUNAY, PU-PH principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fassier-Duval Nail in people with Brittle Bone Disease, run by Assistance Publique Hopitaux De Marseille 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 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: status not confirmed, as of the sponsor's last update on 16 Aug 2016. 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 Franck LAUNAY, PU-PH (franck.launay@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment by radiography intraosseous migration rate (time frame: 72 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 16 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.