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

NCT ID: NCT02655120

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2017-05-31

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 , .. ) .

Conditions

Aseptic Necrosis of Femur Head

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bone Marrow +BMP7

The drilling is completed by a joint supply of autologous marrow unconcentrated and recombinant BMP7 (OP1)

Group Type: EXPERIMENTAL

Bone Marrow +BMP7

Intervention Type: BIOLOGICAL

Drilling

Group I: a simple drill is practiced

Group Type: PLACEBO_COMPARATOR

Drilling

Intervention Type: PROCEDURE

Interventions

Drilling

Intervention Type: PROCEDURE

Bone Marrow +BMP7

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri Migaud, MD, PhD

Role: STUDY_CHAIR

University Hospital, Lille

Locations

CHRU de LILLE - service d'orthopédie C

Lille, , France

Countries

France

Other Identifiers

TC 183

Identifier Type: OTHER

Identifier Source: secondary_id

2005-0503

Identifier Type: -

Identifier Source: org_study_id