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Efficacy of DBM on Fractures of the Shinbone (Tibia)

NCT00299052 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-09-24

No results posted yet for this study

Summary

The Tibia bone (shinbone) is located in the leg, itis the most frequently fractured bone in the body and has very poor blood supply because it is surrounded by skin and fat instead of muscle like the thighbone causing healing problems. Problems frequently found during the healing process are malunion (bone heals in the wrong place), nonunion (the bone never heals), and compartment syndrome (a big inflammation of muscle that causes compression of nerves and blood vessels) with necrosis (death) of tissue. Surgeons have tried to decrease these problems by using different surgical techniques and substances to accelerate healing. Substances frequently used in fractures are bone grafts. Bone grafts are normally obtained from the wrist or the hip bone, and sometimes can cause other complications varying from pain to infection. To avoid complications, investigators have used alternatives such as obtaining bone from donors. The donor bone grafts are carefully analyzed and cleaned to ensure they will not cause problems for the receiver. Bone obtained from donors is called Demineralized Bone Matrix (DBM). DBM has proved to be very effective in helping fractures to heal faster and we want to use it in patients with tibia fractures.

This study is important because DBM can improve the way tibia fractures are treated and could have the potential to decrease the time patients must stay in the hospital. DBM could improve healing time and diminish overall costs. Also, with the use of DBM plus reamings, patients will have fewer complications like pain and infection.

Conditions

  • Closed Fracture
  • Open Fracture

Interventions

DEVICE

Grafton DBM

Grafton DBM will be mixed with bone reamings obtained during tibia IMN and place at the fracture site

BIOLOGICAL

Reamings

Bone reamings obtained during tibia IMN will be placed at the fracture site

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Thomas J Moore, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-12-31
Completion
2008-09-30

Countries

  • United States

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 NCT00299052 on ClinicalTrials.gov