Clinical Trial: Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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.
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 Summary:
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 indepen
Sponsor: University Hospital, Tours
Current Primary Outcome: Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture. [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union. [ Time Frame: one year ]
- Comparison of the rate of complications between the 2 groups. [ Time Frame: one year ]
- Economic impact study. [ Time Frame: one year ]
Original Secondary Outcome: - 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 [ Time Frame: one year ]
Information By: University Hospital, Tours
Dates:
Date Received: August 6, 2007
Date Started: September 2007
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017
