Clinical trial NCT03794622: Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union
Official title: The Effect of Autologous Bone Marrow Concentration on Femoral Shaft Fracture Union
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Marrow
Femoral Shaft Fracture
Keywords: Bone Marrow
Mesenchymal Stromal Cells
Femoral Shaft Fracture
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2019-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive eligible patients who underwent intramedullary nail fixation combined with autologous bone marrow stem cells treatment for 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-month postoperative degree of union evaluated by plain radiograph
timeFrame: 1-month postoperative
Secondary outcomes:
measure: 2-month postoperative degree of union evaluated by plain radiograph
timeFrame: 2-month postoperative
measure: 3-month postoperative degree of union evaluated by plain radiograph
timeFrame: 3-month postoperative
measure: 6-month postoperative degree of union evaluated by plain radiograph
timeFrame: 6-month postoperative
measure: 12-month postoperative degree of union evaluated by plain radiograph
timeFrame: 12-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References: