Tibial Fractures Clinical Trial
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.
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.
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.
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