OsteonecrosisPhase 2NCT00289575
MBCP Safety and Performance in the Osteonecrosis of Femur Head
A Phase 2 study testing MBCP in people with Osteonecrosis, run by Biomatlante at 1 site in France.
Trial summary
The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- MBCP
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Feb 2008
- Phase
- Phase 2
- 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
- femur head osteonecrosis (1 to 2 level in ARCO scale)
- signed informed consent
Who cannot join
- primary bone infection
- femur head sphericity loss
- cancer, diabetes, tuberculosis previous history
- HIV, Hepatitis B, Hepatitis C infection
- drepanocytosis
- current corticotherapy
Show all 10Show fewer
- current immunosuppressive therapy
- innate or acquired immune deficience
- pregnancy or lack of efficient contraception
- current participation in an other study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin
Bordeaux, 33076
Thierry FABRE, ¨Pr, +33556795544, thierry.fabre@chu-bordeaux.fr
Dominique CHAUVEAUX, pr, +33556795679, dominique.chauveaux@chu-bordeaux.fr
About this study
Official title: Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.
The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.
Read the detailed description
Twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. Bone reconstruction will be evaluated with scanner and radiography.
- Conditions
- Osteonecrosis
- Being tested
- MBCP
- Keywords
- Femur head aseptic osteonecrosis, Bone reconstruction, Macroporous biphasic calcium phosphate granules
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection and inflammation of the drilled area (blood and clinical assessment).
Adverse events.
Secondary outcomes (3)
Pain (Analogic Visual Scale)
Hip function
Bone reconstruction evaluation through scanner and radiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Biomatlante
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIC Bordeaux
- Investigators
- Thierry FABRE, Pr, Principal investigator, University Hospital, BordeauxJacques DEMOTES-MAINARD, Pr, Study chair, Clinical Research Center INSERM/Bordeaux University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289575
- Sponsor's protocol ID
- 63
- Status last verified
- Mar 2007
- First submitted
- 9 Feb 2006
- Last updated
- 2 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.
- ClinicalTrials.gov ID
- NCT00289575
- Acronym / sponsor ID
- 63
- Conditions
- Osteonecrosis
- Keywords
- Femur head aseptic osteonecrosis, Bone reconstruction, Macroporous biphasic calcium phosphate granules
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- BiomatlanteIndustry (pharma, biotech, devices)
- Collaborators
- CIC Bordeaux
- Study start
- Feb 2006
- Study completion
- Feb 2008
- First posted
- 10 Feb 2006 (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.
The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.
Detailed description
Twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. Bone reconstruction will be evaluated with scanner and radiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- femur head osteonecrosis (1 to 2 level in ARCO scale)
- signed informed consent
Key exclusion criteria (10 listed)
- primary bone infection
- femur head sphericity loss
- cancer, diabetes, tuberculosis previous history
- HIV, Hepatitis B, Hepatitis C infection
- drepanocytosis
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 |
|---|---|---|
| MBCP | Device | – |
Primary outcome
Infection and inflammation of the drilled area (blood and clinical assessment).
Adverse events.
3 secondary outcomes
Pain (Analogic Visual Scale)
Hip function
Bone reconstruction evaluation through scanner and radiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
Thierry FABRE, Pr principal investigator
University Hospital, Bordeaux
Jacques DEMOTES-MAINARD, Pr study chair
Clinical Research Center INSERM/Bordeaux University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBCP in people with Osteonecrosis, run by Biomatlante 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 2 inclusion and 10 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 2 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thierry FABRE, Pr (+33556795544, thierry.fabre@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection and inflammation of the drilled area (blood and clinical assessment).. The study lists 2 primary outcomes in all. 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 2 Mar 2007.