Grafting, BoneNCT00206791
Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
A study testing MBCP-Gel (tm) and MBCP Gel in people with Grafting, Bone, run by Biomatlante at 4 sites in France.
Trial summary
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Grafting, Bone
- What is being tested?
- MBCP-Gel (tm) and MBCP Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesFrance
- Study dates
- May 2006to May 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medium osseous defects (inferior to 20 cc) without articular communication
- Patients without a personal medical history of bone infection, cancer, diabetes, tuberculosis, and in general, any pathology which could interfere with the results of the study or expose the patient to additional risk
- Patients without drepanocytosis, or congenital or acquired immunizing deficit
- Patients who have the benefit of a social security system, a previous medical exam and who were informed and gave free consent about this study
Who cannot join
- Proven nicotinism and alcoholism
- Pregnant or nursing women
- Patients who received another study drug or another study device in the past 3 months or patients who will be included in another clinical study
- If postoperative follow-up for a patient is considered to be random by the investigator, he/she should not be included
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C
Bordeaux, 33000
CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique
Cannes, 06400
CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie
Fort de France, 97261
Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière
Paris, 75013
About this study
Official title: Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.
Read the detailed description
A lot of osseous substitution products were already used to fill osseous defects in order to prevent losses of osseous that are envisaged and so prejudicial.
Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their osteoconduction potential in human at different sites. But it is difficult to put these granules in very little place.
The injectable form of calcium phosphate granules "ready to use" is easier to be used and allow a diminution of the risk of infection during surgery, and permit homogeneity of the biomaterial.
Injectable form of calcium phosphate granules did already has shown his biocompatibility and biofunctionality in animals.
The purpose of this study is to study the biocompatibility and biofunctionality of this biomaterial in his injectable form in fillings of little losses of osseous substance from various origins were no charge will act to the biomaterial.
- Conditions
- Grafting, Bone
- Being tested
- MBCP-Gel (tm), MBCP Gel
- Keywords
- bone substitutes, Bone Replacement Materials, bone void filler, Grafting, Bone, Bone Cysts
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCP-Gel (tm)Device
Also called injectable resorbable biphasic calcium phosphate
MBCPGel 5ml
MBCP GelDevice
Also called Injectable biphasic calium phosphate
MBCPGel 5ML
| Study group | Role | What they receive |
|---|---|---|
| MBCPGel | Experimental | Not described Receives: Device: MBCP-Gel (tm); Device: MBCP Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery)
Measured: 3, 6 and 12 months
Secondary outcomes (1)
An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2006
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grafting, BoneStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomatlante
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- CATONNE Y, Pr., Principal investigator, Hôpital de la Pitié Salpétrière - 75013 PARIS - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206791
- Sponsor's protocol ID
- 2002/01/001
- Status last verified
- Oct 2006
- First submitted
- 12 Sep 2005
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
- ClinicalTrials.gov ID
- NCT00206791
- Acronym / sponsor ID
- 2002/01/001
- Conditions
- Grafting, Bone
- Keywords
- bone substitutes, Bone Replacement Materials, bone void filler, Grafting, Bone, Bone Cysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BiomatlanteIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Sep 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.
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.
Detailed description
A lot of osseous substitution products were already used to fill osseous defects in order to prevent losses of osseous that are envisaged and so prejudicial.
Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their osteoconduction potential in human at different sites. But it is difficult to put these granules in very little place.
The injectable form of calcium phosphate granules "ready to use" is easier to be used and allow a diminution of the risk of infection during surgery, and permit homogeneity of the biomaterial.
Injectable form of calcium phosphate granules did already has shown his biocompatibility and biofunctionality in animals.
The purpose of this study is to study the biocompatibility and biofunctionality of this biomaterial in his injectable form in fillings of little losses of osseous substance from various origins were no charge will act to the biomaterial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCPGel | Experimental | Device: MBCP-Gel (tm), Device: MBCP Gel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medium osseous defects (inferior to 20 cc) without articular communication
- Patients without a personal medical history of bone infection, cancer, diabetes, tuberculosis, and in general, any pathology which could interfere with the results of the study or expose the patient to additional risk
- Patients without drepanocytosis, or congenital or acquired immunizing deficit
- Patients who have the benefit of a social security system, a previous medical exam and who were informed and gave free consent about this study
Key exclusion criteria (4 listed)
- Proven nicotinism and alcoholism
- Pregnant or nursing women
- Patients who received another study drug or another study device in the past 3 months or patients who will be included in another clinical study
- If postoperative follow-up for a patient is considered to be random by the investigator, he/she should not be included
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-Gel (tm)Also: injectable resorbable biphasic calcium phosphateMBCPGel 5ml | Device | MBCPGel |
| MBCP GelAlso: Injectable biphasic calium phosphateMBCPGel 5ML | Device | MBCPGel |
Primary outcome
Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery)
Time frame: 3, 6 and 12 months
1 secondary outcome
An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
Time frame: 3, 6 and 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 5 Feb 2025.
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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.
CATONNE Y, Pr. principal investigator
Hôpital de la Pitié Salpétrière - 75013 PARIS - France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCP-Gel (tm) and MBCP Gel in people with Grafting, Bone, run by Biomatlante at 4 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 4 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery) (time frame: 3, 6 and 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 5 Feb 2025.