NCT00289575

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 2, 2007

Status Verified

March 1, 2007

First QC Date

February 9, 2006

Last Update Submit

March 1, 2007

Conditions

Osteonecrosis

Keywords

Femur head aseptic osteonecrosisBone reconstructionMacroporous biphasic calcium phosphate granules

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

MBCPDEVICE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • femur head osteonecrosis (1 to 2 level in ARCO scale)
  • signed informed consent

You may not qualify if:

  • primary bone infection
  • femur head sphericity loss
  • cancer, diabetes, tuberculosis previous history
  • HIV, Hepatitis B, Hepatitis C infection
  • drepanocytosis
  • current corticotherapy
  • current immunosuppressive therapy
  • innate or acquired immune deficience
  • pregnancy or lack of efficient contraception
  • current participation in an other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thierry FABRE, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Jacques DEMOTES-MAINARD, Pr

    Clinical Research Center INSERM/Bordeaux University Hospital

    STUDY CHAIR

Central Study Contacts

Thierry FABRE, Pr

CONTACT

+33556795544thierry.fabre@chu-bordeaux.fr

Dominique CHAUVEAUX, Pr

CONTACT

+33556795679dominique.chauveaux@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2008

Last Updated

March 2, 2007

Record last verified: 2007-03

Locations

FR(1)