Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture (IMOCA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00512434
First received: August 6, 2007
Last updated: October 29, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
Tibial Fractures
Fractures, Open
Procedure: Osteosynthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Comparison of the rate of complications between the 2 groups. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Economic impact study. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: September 2007
Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control in arm fields
Standard treatment Intervention no'Osteosynthesis'
Procedure: Osteosynthesis
Nail or external fixator Intervention 'Osteosynthesis'
Experimental: IMOCA
Intervention 'Osteosynthesis' Percutaneous autologous bone-marrow grafting - surgical technique (ref: Hernigou Ph et al J Bone Joint Surg Am ,2006; 88 (sup 1 part 2): 322-327
Procedure: Osteosynthesis
Nail or external fixator Intervention 'Osteosynthesis'

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512434

Locations
France
UH Angers
Angers, France, 49933
UH Besançon Jean Minjoz
Besancon, France, 25030
UH Brest Cavale Blanche
Brest, France, 29200
UH Clermont Ferrand Gabriel Montpied
Clermont Ferrand, France, 63 000
UH Grenoble South Hospital
Grenoble, France, 38434
UH Grenoble Michallon Hospital
Grenoble, France, 38043
UH Nancy Central Hospital
Nancy, France, 54000
UH Nantes Hôtel Dieu
Nantes, France, 44
UH Pitié Salpétrière AH HP
Paris, France, 75013
UH Tours CHRU Trousseau
Tours, France, 37 044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Philippe Rosset, Pr Service d'orthopédie II - CHRU de Tours
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00512434     History of Changes
Other Study ID Numbers: PHRN/06/PR/IMOCA, ID RCB 2007 - A00032 - 51
Study First Received: August 6, 2007
Last Updated: October 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
tibial
shaft
fracture
open
bone-marrow
graft
injection
mesenchymal stem cell

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Open
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 22, 2014