Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

Pei-Yuan Lee, MD

Status

Unknown

Conditions

Bone Marrow

Femoral Shaft Fracture

Treatments

Other: intramedullary nail fixation

Other: intramedullary nail fixation with bone marrow concentration

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03794622

RD106049

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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