Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512434
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2007-08-06
Brief Title:
Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMOCA
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
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 88sup 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
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 88sup 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID RCB 2007 - A00032 - 51 | OTHER | AFSSAPS | None |