Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

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

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.

Study Overview

• Status: Unknown
• Conditions: Femoral Shaft Fracture; Bone Marrow
• Intervention / Treatment: Other: intramedullary nail fixation with bone marrow concentration; Other: intramedullary nail fixation

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Recruiting
      • Show Chwan Memorial Hospital
      • Contact: Hsin-Chuan Chen, MD; Phone Number: +886975611139; Email: henang0424@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bone marrow concentration group; Consecutive patients receive intramedullary nail fixation with bone marrow concentration.	Other: intramedullary nail fixation with bone marrow concentration; intramedullary nail fixation with bone marrow concentration
Historical control group; Previous age- and gender-matched patients who receive intramedullary nail fixation only.	Other: intramedullary nail fixation; intramedullary nail fixation only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Mesenchymal Stromal Cells; Bone Marrow; Femoral Shaft Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: RD106049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No