Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

NCT03794622 | Unknown

• 1 other identifier: RD106049
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow; Femoral Shaft Fracture

Keywords

Bone Marrow; Mesenchymal Stromal Cells; Femoral Shaft Fracture

Outcome Measures

Primary Outcomes (1)

• 1-month postoperative degree of union evaluated by plain radiograph

  Degree of union evaluated by plain radiograph

  1-month postoperative

Secondary Outcomes (4)

• 2-month postoperative degree of union evaluated by plain radiograph

  2-month postoperative

• 3-month postoperative degree of union evaluated by plain radiograph

  3-month postoperative

• 6-month postoperative degree of union evaluated by plain radiograph

  6-month postoperative

• 12-month postoperative degree of union evaluated by plain radiograph

  12-month postoperative

Study Arms (2)

Bone marrow concentration group

Consecutive patients receive intramedullary nail fixation with bone marrow concentration.

Other: 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

Interventions

intramedullary nail fixation with bone marrow concentration OTHER

intramedullary nail fixation with bone marrow concentration

Bone marrow concentration group

intramedullary nail fixation OTHER

intramedullary nail fixation only

Historical control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pei-Yuan Lee, MD: lead
• Aeon Biotechnology Corporation: collaborator

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

RECRUITING

Study Officials

• Pei-Yuan Lee, MD

  Show Chwan Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Hsin-Chuan Chen, MD

CONTACT

+886975611139; henang0424@gmail.com

Pei-Yuan Lee, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 7, 2019
• Study Start: June 14, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)