Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union
- Conditions
- Bone MarrowFemoral Shaft Fracture
- Interventions
- Other: intramedullary nail fixation with bone marrow concentrationOther: intramedullary nail fixation
- Registration Number
- NCT03794622
- Lead Sponsor
- Pei-Yuan Lee, MD
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bone marrow concentration group intramedullary nail fixation with bone marrow concentration Consecutive patients receive intramedullary nail fixation with bone marrow concentration. Historical control group intramedullary nail fixation Previous age- and gender-matched patients who receive intramedullary nail fixation only.
- Primary Outcome Measures
Name Time Method 1-month postoperative degree of union evaluated by plain radiograph 1-month postoperative Degree of union evaluated by plain radiograph
- Secondary Outcome Measures
Name Time Method 6-month postoperative degree of union evaluated by plain radiograph 6-month postoperative Degree of union evaluated by plain radiograph
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
12-month postoperative degree of union evaluated by plain radiograph 12-month postoperative Degree of union evaluated by plain radiograph
Trial Locations
- Locations (1)
Show Chwan Memorial Hospital
🇨🇳Changhua City, Changhua, Taiwan