NCT00512434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

5 years

First QC Date

August 6, 2007

Last Update Submit

October 19, 2018

Conditions

Tibial FracturesFractures, Open

Keywords

tibialshaftfractureopenbone-marrowgraftinjectionmesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve month post fracture.

    one year

Secondary Outcomes (3)

  • Relation between the number of the progenitor available injected with concentrated bone marrow aspirated and the rate of bone union.

    one year

  • Comparison of the rate of complications between the 2 groups.

    one year

  • Economic impact study.

    one year

Study Arms (2)

Control in arm fields

ACTIVE COMPARATOR

Standard treatment Intervention no'Osteosynthesis'

Procedure: Osteosynthesis

IMOCA

EXPERIMENTAL

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

Interventions

OsteosynthesisPROCEDURE

Nail or external fixator Intervention 'Osteosynthesis'

Control in arm fieldsIMOCA

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UH Angers

Angers, 49933, France

Location

UH Besançon Jean Minjoz

Besançon, 25030, France

Location

UH Brest Cavale Blanche

Brest, 29200, France

Location

UH Clermont Ferrand Gabriel Montpied

Clermont-Ferrand, 63 000, France

Location

UH Grenoble Michallon Hospital

Grenoble, 38043, France

Location

UH Grenoble South Hospital

Grenoble, 38434, France

Location

UH Nancy Central Hospital

Nancy, 54000, France

Location

UH Nantes Hôtel Dieu

Nantes, 44, France

Location

UH Pitié Salpétrière AH HP

Paris, 75013, France

Location

UH Tours CHRU Trousseau

Tours, 37 044, France

Location

UHTOURS

Tours, France

Location

MeSH Terms

Conditions

Tibial FracturesFractures, OpenFractures, Bone

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Philippe Rosset, Pr

    Service d'orthopédie II - CHRU de Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

FR(11)