Status:
UNKNOWN
Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union
Lead Sponsor:
Pei-Yuan Lee, MD
Collaborating Sponsors:
Aeon Biotechnology Corporation
Conditions:
Bone Marrow
Femoral Shaft Fracture
Eligibility:
All Genders
20-80 years
Brief Summary
This study aims to evaluate the effect of bone marrow concentration on union of femoral shaft fracture by comparing clinical and imaging outcomes between patients receiving Intramedullary nail fixatio...
Detailed Description
Femoral shaft fracture is a common orthopaedic injury. Intramedullary nail is one of the standard treatments. Its primary goal is to develop an osseous bridge between adjacent motion segments to preve...
Eligibility Criteria
Inclusion
- With recent diagnosis of femoral shaft fracture
- Treated with intramedullary nail fixation
- With one or more risk factors of non-union: comminuted fracture, open fracture, smoking, obesity, diabetes, open reduction,
- Age between 20 and 80 years
Exclusion
- Old femoral shaft fracture
- With concurrent major trauma, ex. intracranial hemorrhage, pneumothorax, hemothorax, internal bleeding.
- With prior history of femoral surgery
- With current or prior history of trauma or infection at femur
- With current diagnosis of coagulopathy
- With current or prior history of cancer
- With current or prior history of hematological disease
- Pregnancy
- Patients who will not cooperate with one-year followup
Key Trial Info
Start Date :
June 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03794622
Start Date
June 14 2017
End Date
December 1 2020
Last Update
April 14 2020
Active Locations (1)
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1
Show Chwan Memorial Hospital
Changhua, Changhua, Taiwan, 500