Tibial Fractures Clinical Trial
— IMOCAOfficial 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.
Verified date | October 2018 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | September 2013 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | UH Angers | Angers | |
France | UH Besançon Jean Minjoz | Besancon | |
France | UH Brest Cavale Blanche | Brest | |
France | UH Clermont Ferrand Gabriel Montpied | Clermont Ferrand | |
France | UH Grenoble Michallon Hospital | Grenoble | |
France | UH Grenoble South Hospital | Grenoble | |
France | UH Nancy Central Hospital | Nancy | |
France | UH Nantes Hôtel Dieu | Nantes | |
France | UH Pitié Salpétrière AH HP | Paris | |
France | UH Tours CHRU Trousseau | Tours | |
France | UHTOURS | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture. | one year | ||
Secondary | Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union. | one year | ||
Secondary | Comparison of the rate of complications between the 2 groups. | one year | ||
Secondary | Economic impact study. | one year |
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