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Trial record 2 of 1813 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

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ClinicalTrials.gov Identifier: NCT03794622
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment
Bone Marrow Femoral Shaft Fracture 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Autologous Bone Marrow Concentration on Femoral Shaft Fracture Union
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. 1-month postoperative degree of union evaluated by plain radiograph [ Time Frame: 1-month postoperative ]
    Degree of union evaluated by plain radiograph


Secondary Outcome Measures :
  1. 2-month postoperative degree of union evaluated by plain radiograph [ Time Frame: 2-month postoperative ]
    Degree of union evaluated by plain radiograph

  2. 3-month postoperative degree of union evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of union evaluated by plain radiograph

  3. 6-month postoperative degree of union evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of union evaluated by plain radiograph

  4. 12-month postoperative degree of union evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of union evaluated by plain radiograph



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794622


Contacts
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Contact: Hsin-Chuan Chen, MD +886975611139 henang0424@gmail.com
Contact: Pei-Yuan Lee, MD

Locations
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Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Contact: Hsin-Chuan Chen, MD    +886975611139    henang0424@gmail.com   
Sponsors and Collaborators
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Investigators
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Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital

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Responsible Party: Pei-Yuan Lee, MD, Principal Investigator, Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03794622     History of Changes
Other Study ID Numbers: RD106049
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pei-Yuan Lee, MD, Show Chwan Memorial Hospital:
Bone Marrow
Mesenchymal Stromal Cells
Femoral Shaft Fracture
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries