Avascular Necrosis of FemurNCT03787329
Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head
An observational study of Avascular Necrosis of Femur and Bone Marrow, 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 avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Avascular Necrosis of Femur, Bone Marrow
- What is being tested?
- Core decompression surgery with bone marrow concentration and Core decompression surgery
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Apr 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: consecutive eligible patients who underwent core decompression combined with autologous bone marrow stem cells treatment for avascular necrosis of the femoral head
Who may be able to join
- Age between 30 and 60 years
- With diagnosis of avascular necrosis of femoral head, Stage I - Stage III
Who cannot join
- With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
- With prior history of hip surgery
- With current or prior history of trauma or infection at hip
- Platelet count < 50,000/µL
- 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.
Taiwan1 site, 1 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua, Changhua, 500
Chang-Han Chuang, MD, +886-975611794, skyman889@gmail.com
About this study
Official title: The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head
This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.
Read the detailed description
Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the disease is characterized by a vascular insult to the blood supply of the femoral head, which can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal stem cells (MSCs) 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, several studies have applied the autologous bone marrow concentration in halting the progression of AVN of femoral head. However, a higher level of evidence for its use on patients suffering from femoral head avascular necrosis has not been reported. This clinical trial will evaluate and compare the eligible patients who undertake core decompression surgery plus intraoperative bone marrow concentration with those who received core decompression surgery only. All patients will be followed for one year and clinical and imaging outcomes will be compared and analyzed.
- Conditions
- Avascular Necrosis of Femur, Bone Marrow
- Being tested
- Core decompression surgery with bone marrow concentration, Core decompression surgery
- Keywords
- Femur Head Necrosis, Mesenchymal Stromal Cells, Bone Marrow
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core decompression surgery with bone marrow concentrationOther
Core decompression surgery with bone marrow concentration
Core decompression surgeryOther
Core decompression surgery only
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow concentration group | The patients receive core decompression surgery with bone marrow concentration. Receives: Other: Core decompression surgery with bone marrow concentration | |
| Historical control group | The previous age-, gender-, and stage-matched patients who received core decompression surgery only. Receives: Other: Core decompression surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month postoperative hip function evaluated by Harris Hip Score
Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: 3-month postoperative
Secondary outcomes (6)
6-month postoperative hip function evaluated by Harris Hip Score
Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: 6-month postoperative
12-month postoperative hip function evaluated by Harris Hip Score
Hip function is evaluated using Harris Hip Score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: 12-month postoperative
3-month postoperative degree of collapse evaluated by plain radiograph
Degree of collapse is evaluated by plain radiograph
Measured: 3-month postoperative
6-month postoperative degree of collapse evaluated by plain radiograph
Degree of collapse is evaluated by plain radiograph
Measured: 6-month postoperative
12-month postoperative degree of collapse evaluated by plain radiograph
Degree of collapse is evaluated by plain radiograph
Measured: 12-month postoperative
6-month postoperative degree of collapse evaluated by MRI
Degree of collapse is evaluated by MRI
Measured: 6-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start14 Apr 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 Avascular Necrosis of FemurStudies 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
- 40 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
- NCT03787329
- Sponsor's protocol ID
- RD-106057
- Status last verified
- Apr 2020
- First submitted
- 22 Dec 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Combined With Core Decompression for Avascular Necrosis of Femoral Head
- ClinicalTrials.gov ID
- NCT03787329
- Acronym / sponsor ID
- RD-106057
- Conditions
- Avascular Necrosis of Femur, Bone Marrow
- Keywords
- Femur Head Necrosis, Mesenchymal Stromal Cells, Bone Marrow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Dec 2018 (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 avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.
Detailed description
Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the disease is characterized by a vascular insult to the blood supply of the femoral head, which can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal stem cells (MSCs) 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, several studies have applied the autologous bone marrow concentration in halting the progression of AVN of femoral head. However, a higher level of evidence for its use on patients suffering from femoral head avascular necrosis has not been reported. This clinical trial will evaluate and compare the eligible patients who undertake core decompression surgery plus intraoperative bone marrow concentration with those who received core decompression surgery only. All patients will be followed for one year and clinical and imaging outcomes will be compared and analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow concentration group | – | Other: Core decompression surgery with bone marrow concentrationThe patients receive core decompression surgery with bone marrow concentration. |
| Historical control group | – | Other: Core decompression surgeryThe previous age-, gender-, and stage-matched patients who received core decompression surgery only. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- consecutive eligible patients who underwent core decompression combined with autologous bone marrow stem cells treatment for avascular necrosis of the femoral head
Key inclusion criteria (2 listed)
- Age between 30 and 60 years
- With diagnosis of avascular necrosis of femoral head, Stage I - Stage III
Key exclusion criteria (9 listed)
- With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
- With prior history of hip surgery
- With current or prior history of trauma or infection at hip
- Platelet count < 50,000/µL
- 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 |
|---|---|---|
| Core decompression surgery with bone marrow concentrationCore decompression surgery with bone marrow concentration | Other | Bone marrow concentration group |
| Core decompression surgeryCore decompression surgery only | Other | Historical control group |
Primary outcome
3-month postoperative hip function evaluated by Harris Hip Score
Time frame: 3-month postoperative
Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
6 secondary outcomes
6-month postoperative hip function evaluated by Harris Hip Score
Time frame: 6-month postoperative
12-month postoperative hip function evaluated by Harris Hip Score
Time frame: 12-month postoperative
3-month postoperative degree of collapse evaluated by plain radiograph
Time frame: 3-month postoperative
6-month postoperative degree of collapse evaluated by plain radiograph
Time frame: 6-month postoperative
12-month postoperative degree of collapse evaluated by plain radiograph
Time frame: 12-month postoperative
6-month postoperative degree of collapse evaluated by MRI
Time frame: 6-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 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 Avascular Necrosis of Femur and Bone Marrow, 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 2 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 Chang-Han Chuang, MD (+886-975611794, skyman889@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month postoperative hip function evaluated by Harris Hip Score (time frame: 3-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.