NCT00206791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 5, 2025

Status Verified

October 1, 2006

Enrollment Period

2.9 years

First QC Date

September 12, 2005

Last Update Submit

February 3, 2025

Conditions

Grafting, Bone

Keywords

bone substitutesBone Replacement Materialsbone void fillerGrafting, BoneBone Cysts

Outcome Measures

Primary Outcomes (1)

  • 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)

    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.

    3, 6 and 12 months

Study Arms (1)

MBCPGel

EXPERIMENTAL
Device: MBCP-Gel (tm)Device: MBCP Gel

Interventions

MBCP-Gel (tm)DEVICE

MBCPGel 5ml

Also known as: injectable resorbable biphasic calcium phosphate
MBCPGel
MBCP GelDEVICE

MBCPGel 5ML

Also known as: Injectable biphasic calium phosphate
MBCPGel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C

Bordeaux, 33000, France

Location

CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique

Cannes, 06400, France

Location

CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie

Fort de France, 97261, France

Location

Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Bone Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • CATONNE Y, Pr.

    Hôpital de la Pitié Salpétrière - 75013 PARIS - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

May 1, 2006

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

February 5, 2025

Record last verified: 2006-10

Locations

FR(4)