Efficacy of DBM on Fractures of the Shinbone (Tibia)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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
More Information
No publications provided
| Responsible Party: | Cathy Hayes, RN, Osteotech |
| ClinicalTrials.gov Identifier: | NCT00299052 History of Changes |
| Other Study ID Numbers: | 1272-2005, 3006 |
| Study First Received: | March 2, 2006 |
| Last Updated: | August 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Tibia Fracture DBM |
Additional relevant MeSH terms:
|
Fractures, Bone Fractures, Closed Fractures, Open Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013