Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Bone Marrow Femoral Shaft Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone marrow concentration group

Consecutive patients receive intramedullary nail fixation with bone marrow concentration.

intramedullary nail fixation with bone marrow concentration

Intervention Type OTHER

intramedullary nail fixation with bone marrow concentration

Historical control group

Previous age- and gender-matched patients who receive intramedullary nail fixation only.

intramedullary nail fixation

Intervention Type OTHER

intramedullary nail fixation only

Interventions

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intramedullary nail fixation with bone marrow concentration

Intervention Type OTHER

intramedullary nail fixation

intramedullary nail fixation only

Intervention Type OTHER

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No