We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Bone Marrow and BMP7 Treatment in the Necrosis in the Femoral Head of the Adult (BMP7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655120
Recruitment Status : Terminated (stopping the marketing of BMP7)
First Posted : January 13, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
The main objective of the study is to evaluate the effectiveness of the injection of bone marrow unconcentrated more R BMP 7 to repair necrosis of the femoral head with stage I-III classification FICAT.

Condition or disease Intervention/treatment Phase
Aseptic Necrosis of Femur Head Procedure: Drilling Biological: Bone Marrow +BMP7 Not Applicable

Detailed Description:

Rationale and Objectives Epiphyseal necrosis are common in young adults (2000 new cases per year in the Nord Pas -de- Calais region) resulting in severe functional impairment and disability . Drilling is the procedure most simple, but its effectiveness and safety are discussed ( fracture risk , long discharge period , success rates below 50 % until stage III). However, it can be optimized in two ways: 1) reducing morbidity and discharge period by reducing the diameter of the channel and percutaneous achievement , 2 ) increase efficiency , including coverage contribution of stem cells and osteogenic hormone . The purpose of this study is to test the effectiveness of the contribution of these elements to the healing necrosis .

Material, Method, and primary endpoint This is a prospective multicenter clinical trial randomized double-blind . The effect of addition of autologous bone marrow stem cells and BMP7 on healing necrosis is assessed by magnetic resonance imaging ( NMRI ) and is the primary endpoint . Patients are randomly assigned to two arms : 1 ) Group I: a simple drilling is practiced , 2 ) Group II : the drilling is completed by a joint supply of autologous marrow unconcentrated and recombinant BMP7 ( OP1 ) . Necrosis of the femoral head with stage I to III are retained Ficat (only stage III with a recess of less than 3 mm are used , corresponding I-III according to Steinberg ) . Forty patients are included in each arm . A IRMN practiced preoperatively and at 6 months and 2 years. Clinical evaluation will be continued up to 5 years in testing the survival rate ( criterion censorship = recovery by hip ) Expected results and possible implications In terms of radiological stabilization ( NMRI ) the effectiveness of single drilling necrosis stage I to III Ficat is 60 % ( non- stabilization or worsening of size). The hypothesis tested is a gain stabilization ( and / or recovery) of 20 % . The clinical efficacy of single drilling necrosis stage I to III Ficat is estimated at 50 % (50% recovery by prosthesis in 5 years) . The assumption is a 20% improvement in the rate of success of the intervention . Reducing morbidity due to technical modifications has been previously tested. If the assumption of success is reached, the indications of drilling could be reinforced especially for patients with multiple visceral defects usually supported on the websites of University Hospital of Lille and Amiens and CH Roubaix ( organ transplant or tissue , ethyl , .. ) .

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Autologous Bone Marrow no Concentrated to Associate at BMP7 Treatment of Necrosis of the Femoral Head of the Adult
Study Start Date : March 2005
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Bone Marrow +BMP7
The drilling is completed by a joint supply of autologous marrow unconcentrated and recombinant BMP7 (OP1)
Biological: Bone Marrow +BMP7
Placebo Comparator: Drilling
Group I: a simple drill is practiced
Procedure: Drilling



Primary Outcome Measures :
  1. Necrosis volume [ Time Frame: 24 months ]
    Varying the volume of necrosis in MRI, student test comparing the mean (independent samples).


Secondary Outcome Measures :
  1. Merle d'aubigné hip score [ Time Frame: 6 and 24 months ]
    variation of functional score, according to the two groups, by ANOVA repeated measures

  2. Measurement of radiographic stage variation between pre-operative and 24 months radiographies using concentric circles of Möse [ Time Frame: 24 months ]
  3. Comparison of hip survival by measuring the number of revisions for hip replacement in the 2 groups [ Time Frame: 60 months ]
    Hip survival (= no revision for hip replacement) will be assessed using Kaplan-Meier curves and Logrank test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged between 18 and 60 years male or female.
  • Necrosis of the femoral head stage I to III FICAT (stage III with depression of less than 3 mm)
  • Nontraumatic osteonecrosis
  • Patient can undergo general anesthesia or locoregional
  • Having given his consent
  • Able to understand the constraints of the study

Exclusion Criteria:

  • Refusing to participate in the study
  • Active infection at the site
  • Cancer changing
  • Pregnancy
  • Necrosis posttraumatic
  • Having already undergone surgery on the surgical site
  • Contraindication to the practice of NMRI
  • Contraindication to the use of OP1 (BMP7): collagen, arthritis, scleroderma, lupus
  • Patient participating in another ongoing study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655120


Locations
Layout table for location information
France
CHRU de LILLE - service d'orthopédie C
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Study Chair: Henri Migaud, MD, PhD University Hospital, Lille
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02655120    
Other Study ID Numbers: 2005-0503
TC 183 ( Other Identifier: therapy cellulaire number, ANSM )
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by University Hospital, Lille:
Femoral head necrosis
Autologous Bone Marrow
BMP7
Additional relevant MeSH terms:
Layout table for MeSH terms
Femur Head Necrosis
Necrosis
Pathologic Processes
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases