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临床试验/NCT00299052
NCT00299052已完成4 期

The Efficacy of Demineralized Bone Matrix and Autogenous Bone Graft in Accelerated Fracture Healing in Closed Tibia Fracture

Emory University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Fracture healing

研究概览

简要总结

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.

详细描述

Duration This study will last for 24 months.

Subject Recruitment

Inclusion criteria:

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

Exclusion criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Fracture healing

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Moore

Principal Investigator

Emory University

研究点 (2)

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