Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

Femoral Shaft Fracture Clinical Trial

Official title:

The Effect of Autologous Bone Marrow Concentration on Femoral Shaft Fracture Union

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794622
• Other study ID #: RD106049
• Status: Recruiting
• Start date: June 14, 2017
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Show Chwan Memorial Hospital
• Contact: Hsin-Chuan Chen, MD
• Phone: +886975611139
• Email: henang0424[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 fixation with intraoperative bone marrow concentration and those receiving Intramedullary nail fixation only.

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 prevent motion, relieve pain, and facilitate bone union. Delayed union or nonunion is common in femoral shaft fracture. Risk factors include comminuted fracture, open fracture, smoking, diabetes and open reduction of fracture fixation. Mesenchymal stem cells are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve bone healing. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on union of femoral shaft fracture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Bone Marrow
• Femoral Fractures
• Femoral Shaft Fracture
• Fractures, Bone

Intervention

Other:
• intramedullary nail fixation with bone marrow concentration
intramedullary nail fixation with bone marrow concentration
• intramedullary nail fixation
intramedullary nail fixation only

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-month postoperative degree of union evaluated by plain radiograph	Degree of union evaluated by plain radiograph	1-month postoperative
Secondary	2-month postoperative degree of union evaluated by plain radiograph	Degree of union evaluated by plain radiograph	2-month postoperative
Secondary	3-month postoperative degree of union evaluated by plain radiograph	Degree of union evaluated by plain radiograph	3-month postoperative
Secondary	6-month postoperative degree of union evaluated by plain radiograph	Degree of union evaluated by plain radiograph	6-month postoperative
Secondary	12-month postoperative degree of union evaluated by plain radiograph	Degree of union evaluated by plain radiograph	12-month postoperative