Bone MarrowNCT03794622
Autologous Bone Marrow Concentration for Femoral Shaft Fracture Union
An observational study of Bone Marrow and Femoral Shaft Fracture, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Bone Marrow, Femoral Shaft Fracture
- What is being tested?
- intramedullary nail fixation with bone marrow concentration and intramedullary nail fixation
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jun 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive eligible patients who underwent intramedullary nail fixation combined with autologous bone marrow stem cells treatment for femoral shaft fracture
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- With current or prior history of hematological disease
- Pregnancy
- Patients who will not cooperate with one-year followup
Trial locations and contacts
1 site in 1 country.
Pei-Yuan Lee, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua, Changhua, 500
Hsin-Chuan Chen, MD, +886975611139, henang0424@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Marrow, Femoral Shaft Fracture
- Being tested
- intramedullary nail fixation with bone marrow concentration, intramedullary nail fixation
- Keywords
- Bone Marrow, Mesenchymal Stromal Cells, Femoral Shaft Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary nail fixation with bone marrow concentrationOther
intramedullary nail fixation with bone marrow concentration
intramedullary nail fixationOther
intramedullary nail fixation only
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow concentration group | Consecutive patients receive intramedullary nail fixation with bone marrow concentration. Receives: Other: intramedullary nail fixation with bone marrow concentration | |
| Historical control group | Previous age- and gender-matched patients who receive intramedullary nail fixation only. Receives: Other: intramedullary nail fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-month postoperative degree of union evaluated by plain radiograph
Degree of union evaluated by plain radiograph
Measured: 1-month postoperative
Secondary outcomes (4)
2-month postoperative degree of union evaluated by plain radiograph
Degree of union evaluated by plain radiograph
Measured: 2-month postoperative
3-month postoperative degree of union evaluated by plain radiograph
Degree of union evaluated by plain radiograph
Measured: 3-month postoperative
6-month postoperative degree of union evaluated by plain radiograph
Degree of union evaluated by plain radiograph
Measured: 6-month postoperative
12-month postoperative degree of union evaluated by plain radiograph
Degree of union evaluated by plain radiograph
Measured: 12-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start14 Jun 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MarrowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pei-Yuan Lee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Responsible party
- Sponsor-investigator, Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
- Investigators
- Pei-Yuan Lee, MD, Study chair, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794622
- Sponsor's protocol ID
- RD106049
- Status last verified
- Apr 2020
- First submitted
- 2 Jan 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autologous Bone Marrow Concentration on Femoral Shaft Fracture Union
- ClinicalTrials.gov ID
- NCT03794622
- Acronym / sponsor ID
- RD106049
- Conditions
- Bone Marrow, Femoral Shaft Fracture
- Keywords
- Bone Marrow, Mesenchymal Stromal Cells, Femoral Shaft Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow concentration group | – | Other: intramedullary nail fixation with bone marrow concentrationConsecutive patients receive intramedullary nail fixation with bone marrow concentration. |
| Historical control group | – | Other: intramedullary nail fixationPrevious age- and gender-matched patients who receive intramedullary nail fixation only. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive eligible patients who underwent intramedullary nail fixation combined with autologous bone marrow stem cells treatment for femoral shaft fracture
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intramedullary nail fixation with bone marrow concentrationintramedullary nail fixation with bone marrow concentration | Other | Bone marrow concentration group |
| intramedullary nail fixationintramedullary nail fixation only | Other | Historical control group |
Primary outcome
1-month postoperative degree of union evaluated by plain radiograph
Time frame: 1-month postoperative
Degree of union evaluated by plain radiograph
4 secondary outcomes
2-month postoperative degree of union evaluated by plain radiograph
Time frame: 2-month postoperative
3-month postoperative degree of union evaluated by plain radiograph
Time frame: 3-month postoperative
6-month postoperative degree of union evaluated by plain radiograph
Time frame: 6-month postoperative
12-month postoperative degree of union evaluated by plain radiograph
Time frame: 12-month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Yuan Lee, MD contact
Pei-Yuan Lee, MD study chair
Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow and Femoral Shaft Fracture, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Chuan Chen, MD (+886975611139, henang0424@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-month postoperative degree of union evaluated by plain radiograph (time frame: 1-month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.