Bone MarrowNCT03793530
Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery
A study testing Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration and Transforaminal lumbar interbody fusion with local bone graft in people with Bone Marrow and Spinal Fusion, 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 bone healing and spinal fusion by comparing clinical and imaging outcomes between patients receiving transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone marrow concentration and those receiving transforaminal… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Bone Marrow, Spinal Fusion
- What is being tested?
- Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration and Transforaminal lumbar interbody fusion with local bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to Dec 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With indication of transforaminal lumbar decomprassion and interbody fusion, ex. spondylolisthesis, symptomatic degenerative disease, spinal instability.
- Involved levels between T12 and S1
- Involved levels less than three levels
- Age between 20 and 70 years
Who cannot join
- With prior history of spinal surgery
- With current or prior history of tumor, trauma or infection at spine
- 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
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
Ming-Hsien Hu, MD, +886-975611289, minghsienhu@gmail.com
About this study
Official title: The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial
This study aims to evaluate the effect of bone marrow concentration on bone healing and spinal fusion by comparing clinical and imaging outcomes between patients receiving transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone marrow concentration and those receiving transforaminal lumbar intebody fusion with local bone graft only.
Read the detailed description
Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain, and facilitate neurological recovery. One of the arthrodesis method is transforaminal lumbar intebody fusion. After removal of the problematic disc, iliac crest bone graft was harvested and impacted into the space with cage to facilitate fusion. However, patients are exposed to additional risk of harvesting site, such as pain, infection, wound healing problem or hematomas. Local bone graft harvested from decompression is one of the alternative solutions to avoid these complications. However, the effect of local boen graft is inferior to iliac crest bone graft because iliac crest bone graft contains three important ingredients for successful fusion: osteoconductive scaffold, osteoinductive factors, and the ability to osteogenesis. 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, some studies have shown that autologous bone marrow concentration can improve bone healing. In this study, we will add bone marrow concentration into local bone graft during transforaminal lumbar intebody fusion and evaluate the effect of bone marrow concentration on bone healing and spinal fusion.
- Conditions
- Bone Marrow, Spinal Fusion
- Being tested
- Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration, Transforaminal lumbar interbody fusion with local bone graft
- Keywords
- Bone Marrow, Mesenchymal Stromal Cells, spine fusion surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentrationOther
Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
Transforaminal lumbar interbody fusion with local bone graftOther
Transforaminal lumbar interbody fusion with local bone graft
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow concentration group | Experimental | Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration Receives: Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration |
| Control group | Active comparator | Transforaminal lumbar interbody fusion with local bone graft Receives: Other: Transforaminal lumbar interbody fusion with local bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month postoperative spinal function evaluated by Oswestry Disability Index
Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
Measured: 3-month postoperative
Secondary outcomes (9)
6-month postoperative spinal function evaluated by Oswestry Disability Index
Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
Measured: 6-month postoperative
12-month postoperative spinal function evaluated by Oswestry Disability Index
Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
Measured: 12-month postoperative
3-month postoperative degree of pain evaluated by visual analogue scale
Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
Measured: 3-month postoperative
6-month postoperative degree of pain evaluated by visual analogue scale
Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
Measured: 6-month postoperative
12-month postoperative degree of pain evaluated by visual analogue scale
Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
Measured: 12-month postoperative
3-month postoperative degree of bone healing evaluated by plain radiograph
Degree of bone healing evaluated by plain radiograph
Measured: 3-month postoperative
6-month postoperative degree of bone healing evaluated by plain radiograph
Degree of bone healing evaluated by plain radiograph
Measured: 6-month postoperative
12-month postoperative degree of bone healing evaluated by plain radiograph
Degree of bone healing evaluated by plain radiograph
Measured: 12-month postoperative
12-month postoperative degree of bone healing evaluated by computed tomograph
Degree of bone healing evaluated by computed tomograph
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 posted4 Jan 2019
- Study start1 Aug 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT03793530
- Sponsor's protocol ID
- RD106050
- 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
Publications
Hu MH, Tseng YK, Chung YH, Wu NY, Li CH, Lee PY. The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial. BMC Musculoskelet Disord. 2022 Nov 18;23(1):996. doi: 10.1186/s12891-022-05948-9.
PubMed 36401234
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 Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03793530
- Acronym / sponsor ID
- RD106050
- Conditions
- Bone Marrow, Spinal Fusion
- Keywords
- Bone Marrow, Mesenchymal Stromal Cells, spine fusion surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 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 bone healing and spinal fusion by comparing clinical and imaging outcomes between patients receiving transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone marrow concentration and those receiving transforaminal lumbar intebody fusion with local bone graft only.
Detailed description
Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain, and facilitate neurological recovery. One of the arthrodesis method is transforaminal lumbar intebody fusion. After removal of the problematic disc, iliac crest bone graft was harvested and impacted into the space with cage to facilitate fusion. However, patients are exposed to additional risk of harvesting site, such as pain, infection, wound healing problem or hematomas. Local bone graft harvested from decompression is one of the alternative solutions to avoid these complications. However, the effect of local boen graft is inferior to iliac crest bone graft because iliac crest bone graft contains three important ingredients for successful fusion: osteoconductive scaffold, osteoinductive factors, and the ability to osteogenesis. 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, some studies have shown that autologous bone marrow concentration can improve bone healing. In this study, we will add bone marrow concentration into local bone graft during transforaminal lumbar intebody fusion and evaluate the effect of bone marrow concentration on bone healing and spinal fusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow concentration group | Experimental | Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentrationTransforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration |
| Control group | Active comparator | Other: Transforaminal lumbar interbody fusion with local bone graftTransforaminal lumbar interbody fusion with local bone graft |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With indication of transforaminal lumbar decomprassion and interbody fusion, ex. spondylolisthesis, symptomatic degenerative disease, spinal instability.
- Involved levels between T12 and S1
- Involved levels less than three levels
- Age between 20 and 70 years
Key exclusion criteria (7 listed)
- With prior history of spinal surgery
- With current or prior history of tumor, trauma or infection at spine
- With current diagnosis of coagulopathy
- With current or prior history of cancer
- With current or prior history of hematological disease
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 |
|---|---|---|
| Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentrationTransforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration | Other | Bone marrow concentration group |
| Transforaminal lumbar interbody fusion with local bone graftTransforaminal lumbar interbody fusion with local bone graft | Other | Control group |
Primary outcome
3-month postoperative spinal function evaluated by Oswestry Disability Index
Time frame: 3-month postoperative
Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
9 secondary outcomes
6-month postoperative spinal function evaluated by Oswestry Disability Index
Time frame: 6-month postoperative
12-month postoperative spinal function evaluated by Oswestry Disability Index
Time frame: 12-month postoperative
3-month postoperative degree of pain evaluated by visual analogue scale
Time frame: 3-month postoperative
6-month postoperative degree of pain evaluated by visual analogue scale
Time frame: 6-month postoperative
12-month postoperative degree of pain evaluated by visual analogue scale
Time frame: 12-month postoperative
3-month postoperative degree of bone healing evaluated by plain radiograph
Time frame: 3-month postoperative
6-month postoperative degree of bone healing evaluated by plain radiograph
Time frame: 6-month postoperative
12-month postoperative degree of bone healing evaluated by plain radiograph
Time frame: 12-month postoperative
12-month postoperative degree of bone healing evaluated by computed tomograph
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.
- Derived from this study: PubMed 36401234Hu MH, Tseng YK, Chung YH, Wu NY, Li CH, Lee PY. The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial. BMC Musculoskelet Disord. 2022 Nov 18;23(1):996. doi: 10.1186/s12891-022-05948-9.
- 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?
A study testing Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration and Transforaminal lumbar interbody fusion with local bone graft in people with Bone Marrow and Spinal Fusion, 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 7 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 Ming-Hsien Hu, MD (+886-975611289, minghsienhu@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 spinal function evaluated by Oswestry Disability Index (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?
On the ClinicalTrials.gov record for NCT03793530, which also lists 1 linked publication.
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.