Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture (IMOCA)
Primary Purpose
Tibial Fractures, Fractures, Open
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteosynthesis
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures focused on measuring tibial, shaft, fracture, open, bone-marrow, graft, injection, mesenchymal stem cell
Eligibility Criteria
Inclusion Criteria:
- Age 17 years or more
- Open tibial shaft fracture with Gustilo-Anderson type I, II, III A or B
- Written informed consent
- Affiliated to French Social Security
Exclusion Criteria:
- Circumferential bone loss
- Vascular or nerve injury
- Injury, other than tibial fracture, interfering with weight bearing
- Infection (skin, soft-tissue or bone)
- Disease or treatment interfering with bone union: head injury with coma, pathologic fracture
- Medical history on iliac wing contraindicating bone-marrow aspiration
- Corticoid or immunosuppressive therapy more than one week
- Pregnancy at the day of inclusion in study
- History of positive serology for HIV1+2, HBs, HCV
- Adult in the care of a guardian
- Impossibility to meet at the appointments for the follow-up
Sites / Locations
- UH Angers
- UH Besançon Jean Minjoz
- UH Brest Cavale Blanche
- UH Clermont Ferrand Gabriel Montpied
- UH Grenoble Michallon Hospital
- UH Grenoble South Hospital
- UH Nancy Central Hospital
- UH Nantes Hôtel Dieu
- UH Pitié Salpétrière AH HP
- UH Tours CHRU Trousseau
- UHTOURS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control in arm fields
IMOCA
Arm Description
Standard treatment Intervention no'Osteosynthesis'
Intervention 'Osteosynthesis' Percutaneous autologous bone-marrow grafting - surgical technique (ref: Hernigou Ph et al J Bone Joint Surg Am ,2006; 88 (sup 1 part 2): 322-327
Outcomes
Primary Outcome Measures
Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture.
Secondary Outcome Measures
Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union.
Comparison of the rate of complications between the 2 groups.
Economic impact study.
Full Information
NCT ID
NCT00512434
First Posted
August 6, 2007
Last Updated
October 19, 2018
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT00512434
Brief Title
Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
Acronym
IMOCA
Official Title
Injection of Concentrated Autologous Bone-marrow (IMOCA) and Bone Union of Open Tibial Shaft Fracture: Randomized Study to Assess Efficiency of IMOCA in Addition to Standard of Care.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention.
In a prospective, randomized, controlled, single-blind study, 186 patients with an open tibial will be randomized to receive either the standard of care (fixation by nail or external fixator and routine soft-tissue management), or the standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow. Randomization will be stratified by severity of the open wound. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post-fracture.
Detailed Description
This study will be conducted at 13 University Hospitals in France. The protocol has been approved by the institutional review board. After written informed consent, patients will be randomized, in the days after the fracture in 2 groups of 93 patients : 1) the control group (standard of care only: fixation by nail or external fixator and routine soft-tissue management) and 2) the study group (standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow). Randomization will be stratified by severity of the open wound and by center. For the wound, strata A comprise Gustilo-Anderson types I, II and III-A and strata B, type III-B.
For the study group, the injection is scheduled at 1 month ± 5 days after the fracture. The techniques have been described by Hernigou (J Bone Joint Surg Am, 2006; 88(sup 1 part 2): 322-327). There are 3 steps: marrow aspiration (300 - 500 g) from iliac crest under general anesthesia, centrifugation in cell therapy unit to obtain a concentrated buffy coat of about 50 ml containing progenitor cells and other mononuclear cells, percutaneous injection in the fracture site of 20-30 ml of the buffy coat under fluoroscopy control.
Apart from the injection, the standard of care is the same for the 2 groups. Patients will be followed for 12 months, with assessments at 1, 2, 3, 6, 9 and 12 months.
All analysis will be based on the intent to treat the population. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post fracture. An independent panel of surgeons will evaluate all secondary procedure with the potential of promoting fracture-healing.
An independent evaluation of fracture union will be conducted by a radiology panel blinded to treatment allocation and all other patient data.
An outcome will be considered to be successful when the fracture heal, according to the investigator, without secondary intervention and is radiographically united during patient follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Fractures, Open
Keywords
tibial, shaft, fracture, open, bone-marrow, graft, injection, mesenchymal stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control in arm fields
Arm Type
Active Comparator
Arm Description
Standard treatment Intervention no'Osteosynthesis'
Arm Title
IMOCA
Arm Type
Experimental
Arm Description
Intervention 'Osteosynthesis' Percutaneous autologous bone-marrow grafting - surgical technique (ref: Hernigou Ph et al J Bone Joint Surg Am ,2006; 88 (sup 1 part 2): 322-327
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis
Intervention Description
Nail or external fixator Intervention 'Osteosynthesis'
Primary Outcome Measure Information:
Title
Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union.
Time Frame
one year
Title
Comparison of the rate of complications between the 2 groups.
Time Frame
one year
Title
Economic impact study.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 17 years or more
Open tibial shaft fracture with Gustilo-Anderson type I, II, III A or B
Written informed consent
Affiliated to French Social Security
Exclusion Criteria:
Circumferential bone loss
Vascular or nerve injury
Injury, other than tibial fracture, interfering with weight bearing
Infection (skin, soft-tissue or bone)
Disease or treatment interfering with bone union: head injury with coma, pathologic fracture
Medical history on iliac wing contraindicating bone-marrow aspiration
Corticoid or immunosuppressive therapy more than one week
Pregnancy at the day of inclusion in study
History of positive serology for HIV1+2, HBs, HCV
Adult in the care of a guardian
Impossibility to meet at the appointments for the follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Rosset, Pr
Organizational Affiliation
Service d'orthopédie II - CHRU de Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
UH Besançon Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
UH Brest Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
UH Clermont Ferrand Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63 000
Country
France
Facility Name
UH Grenoble Michallon Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
UH Grenoble South Hospital
City
Grenoble
ZIP/Postal Code
38434
Country
France
Facility Name
UH Nancy Central Hospital
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
UH Nantes Hôtel Dieu
City
Nantes
ZIP/Postal Code
44
Country
France
Facility Name
UH Pitié Salpétrière AH HP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
UH Tours CHRU Trousseau
City
Tours
ZIP/Postal Code
37 044
Country
France
Facility Name
UHTOURS
City
Tours
Country
France
12. IPD Sharing Statement
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Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
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