Autologous Bone Marrow and BMP7 Treatment in the Necrosis in the Femoral Head of the Adult (BMP7)
Primary Purpose
Aseptic Necrosis of Femur Head
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Drilling
Bone Marrow +BMP7
Sponsored by
About this trial
This is an interventional treatment trial for Aseptic Necrosis of Femur Head focused on measuring Femoral head necrosis, Autologous Bone Marrow, BMP7
Eligibility 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
Sites / Locations
- CHRU de LILLE - service d'orthopédie C
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bone Marrow +BMP7
Drilling
Arm Description
The drilling is completed by a joint supply of autologous marrow unconcentrated and recombinant BMP7 (OP1)
Group I: a simple drill is practiced
Outcomes
Primary Outcome Measures
Necrosis volume
Varying the volume of necrosis in MRI, student test comparing the mean (independent samples).
Secondary Outcome Measures
Merle d'aubigné hip score
variation of functional score, according to the two groups, by ANOVA repeated measures
Measurement of radiographic stage variation between pre-operative and 24 months radiographies using concentric circles of Möse
Comparison of hip survival by measuring the number of revisions for hip replacement in the 2 groups
Hip survival (= no revision for hip replacement) will be assessed using Kaplan-Meier curves and Logrank test.
Full Information
NCT ID
NCT02655120
First Posted
November 12, 2014
Last Updated
May 2, 2018
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02655120
Brief Title
Autologous Bone Marrow and BMP7 Treatment in the Necrosis in the Femoral Head of the Adult
Acronym
BMP7
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 Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
stopping the marketing of BMP7
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 , .. ) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aseptic Necrosis of Femur Head
Keywords
Femoral head necrosis, Autologous Bone Marrow, BMP7
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone Marrow +BMP7
Arm Type
Experimental
Arm Description
The drilling is completed by a joint supply of autologous marrow unconcentrated and recombinant BMP7 (OP1)
Arm Title
Drilling
Arm Type
Placebo Comparator
Arm Description
Group I: a simple drill is practiced
Intervention Type
Procedure
Intervention Name(s)
Drilling
Intervention Type
Biological
Intervention Name(s)
Bone Marrow +BMP7
Primary Outcome Measure Information:
Title
Necrosis volume
Description
Varying the volume of necrosis in MRI, student test comparing the mean (independent samples).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Merle d'aubigné hip score
Description
variation of functional score, according to the two groups, by ANOVA repeated measures
Time Frame
6 and 24 months
Title
Measurement of radiographic stage variation between pre-operative and 24 months radiographies using concentric circles of Möse
Time Frame
24 months
Title
Comparison of hip survival by measuring the number of revisions for hip replacement in the 2 groups
Description
Hip survival (= no revision for hip replacement) will be assessed using Kaplan-Meier curves and Logrank test.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri Migaud, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Study Chair
Facility Information:
Facility Name
CHRU de LILLE - service d'orthopédie C
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
Autologous Bone Marrow and BMP7 Treatment in the Necrosis in the Femoral Head of the Adult
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