Bone Marrow, Femoral Shaft Fracture
Conditions
Keywords
Bone Marrow, Mesenchymal Stromal Cells, Femoral Shaft Fracture
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 fixation with intraoperative bone marrow concentration and those receiving Intramedullary nail fixation only.
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 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.
Interventions
OTHERintramedullary nail fixation with bone marrow concentration
intramedullary nail fixation with bone marrow concentration
intramedullary nail fixation only
Sponsors
Aeon Biotechnology Corporation
Pei-Yuan Lee, MD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-month postoperative degree of union evaluated by plain radiograph | 1-month postoperative | Degree of union evaluated by plain radiograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-month postoperative degree of union evaluated by plain radiograph | 2-month postoperative | Degree of union evaluated by plain radiograph |
| 3-month postoperative degree of union evaluated by plain radiograph | 3-month postoperative | Degree of union evaluated by plain radiograph |
| 6-month postoperative degree of union evaluated by plain radiograph | 6-month postoperative | Degree of union evaluated by plain radiograph |
| 12-month postoperative degree of union evaluated by plain radiograph | 12-month postoperative | Degree of union evaluated by plain radiograph |
Countries
Taiwan
Contacts
Primary ContactHsin-Chuan Chen, MD
Backup ContactPei-Yuan Lee, MD
Outcome results
None listed