Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-01 @ 4:37 AM
Study NCT ID:
NCT00512434
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
Sponsor:
University Hospital, Tours
Organization:
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; 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.
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.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID RCB 2007 - A00032 - 51 | OTHER | AFSSAPS | View |