Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Marrow, Femoral Shaft Fracture

Intervention / Treatment
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* Other: intramedullary nail fixation with bone marrow concentration
* Other: intramedullary nail fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone marrow concentration group<br>Consecutive patients receive intramedullary nail fixation with bone marrow concentration. | Other: intramedullary nail fixation with bone marrow concentration<br>* intramedullary nail fixation with bone marrow concentration<br>|
| Historical control group<br>Previous age- and gender-matched patients who receive intramedullary nail fixation only. | Other: intramedullary nail fixation<br>* intramedullary nail fixation only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-month postoperative degree of union evaluated by plain radiograph | Degree of union evaluated by plain radiograph | 1-month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-month postoperative degree of union evaluated by plain radiograph | Degree of union evaluated by plain radiograph | 2-month postoperative | 
| 3-month postoperative degree of union evaluated by plain radiograph | Degree of union evaluated by plain radiograph | 3-month postoperative | 
| 6-month postoperative degree of union evaluated by plain radiograph | Degree of union evaluated by plain radiograph | 6-month postoperative | 
| 12-month postoperative degree of union evaluated by plain radiograph | Degree of union evaluated by plain radiograph | 12-month postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow, Mesenchymal Stromal Cells, Femoral Shaft Fracture