Autologous Bone Marrow Concentration for Femoral Shaft Fr... | NCT03794622

Studies
Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union

NCT03794622

Sponsor

Pei-Yuan Lee, MD

Status

Unknown status

Last Update Posted

Apr 14, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Bone Marrow
Femoral Shaft Fracture

Interventions

intramedullary nail fixation with bone marrow concentration
intramedullary nail fixation

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2017Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2020

Last Update Posted Date

Apr 14, 2020Actual

Name	Class
Aeon Biotechnology Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
intramedullary nail fixation with bone marrow concentration	Other	intramedullary nail fixation with bone marrow concentration	Bone marrow concentration group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

consecutive eligible patients who underwent intramedullary nail fixation combined with autologous bone marrow stem cells treatment for femoral shaft fracture

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hsin-Chuan Chen, MD	Contact	+886975611139		henang0424@gmail.com
Pei-Yuan Lee, MD	Contact

Overall Officials

Name	Affiliation	Role
Pei-Yuan Lee, MD	Show Chwan Memorial Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Show Chwan Memorial Hospital	Recruiting	Changhua	Changhua	500	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided