Efficacy of DBM on Fractures of the Shinbone (Tibia)

NCT00299052 | Completed Phase 4

• 2 other identifiers: 1272-20053006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tibia; Fracture; DBM

Outcome Measures

Primary Outcomes (1)

• Fracture healing

  Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery

Study Arms (2)

A

ACTIVE COMPARATOR

Bone reamings with 5cc of DMB putty

Device: Grafton DBM

B

ACTIVE COMPARATOR

Bone reamings

Biological: Reamings

Interventions

Grafton DBM DEVICE

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

A

Reamings BIOLOGICAL

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Fractures, Closed; Fractures, Open; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Thomas J Moore, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 6, 2006
• Study Start: March 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

US (1)