Efficacy of DBM on Fractures of the Shinbone (Tibia)
Completed · Phase 4
Conditions studied: Closed Fracture, Open Fracture
In brief
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.
Key facts
- Study ID
- NCT00299052
- Run by
- Emory University
- People needed
- 16
- Starts
- 2006-03-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2013-09-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients presenting diaphyseal tibia fractures.
- Patients older than 18 years old
- Patients that will undergo IM nailing as definitive treatment.
You may not qualify if…
- Patients presenting diaphyseal tibia fractures.
- Patients older than 18 years old
- Patients that will undergo IM nailing as definitive treatment.
Where it is running
- Grady Memorial Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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