Efficacy of DBM on Fractures of the Shinbone (Tibia)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Moore, Emory University
ClinicalTrials.gov Identifier:
NCT00299052
First received: March 2, 2006
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Closed Fracture
Open Fracture
Device: Grafton DBM
Biological: Reamings
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Demineralized Bone Matrix and Autogenous Bone Graft in Accelerated Fracture Healing in Closed Tibia Fracture

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Fracture healing [ Time Frame: Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Bone reamings with 5cc of DMB putty
Device: Grafton DBM
Grafton DBM will be mixed with bone reamings obtained during tibia IMN and place at the fracture site
Active Comparator: B
Bone reamings
Biological: Reamings
Bone reamings obtained during tibia IMN will be placed at the fracture site

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting diaphyseal tibia fractures.

    • Patients older than 18 years old
    • Patients that will undergo IM nailing as definitive treatment.

Exclusion Criteria:

  • Patients presenting diaphyseal tibia fractures.
  • Patients older than 18 years old
  • Patients that will undergo IM nailing as definitive treatment.
  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: NCT00299052

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Thomas J Moore, MD Emory University
  More Information

No publications provided

Responsible Party: Thomas Moore, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00299052     History of Changes
Other Study ID Numbers: 1272-2005, 3006
Study First Received: March 2, 2006
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Tibia
Fracture
DBM

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

ClinicalTrials.gov processed this record on October 02, 2014