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Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture

NCT00512434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-10-22

No results posted yet for this study

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.

Conditions

  • Tibial Fractures
  • Fractures, Open

Interventions

PROCEDURE

Osteosynthesis

Nail or external fixator Intervention 'Osteosynthesis'

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Philippe Rosset, Pr · Service d'orthopédie II - CHRU de Tours

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-09-30
Completion
2013-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00512434 on ClinicalTrials.gov