Bone Marrow, Spinal Fusion
Conditions
Keywords
Bone Marrow, Mesenchymal Stromal Cells, spine fusion surgery
Brief 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 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.
Interventions
OTHERTransforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
OTHERTransforaminal lumbar interbody fusion with local bone graft
Transforaminal lumbar interbody fusion with local bone graft
Sponsors
Aeon Biotechnology Corporation
Pei-Yuan Lee, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month postoperative spinal function evaluated by Oswestry Disability Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month postoperative spinal function evaluated by Oswestry Disability Index | 12-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. |
| 3-month postoperative degree of pain evaluated by visual analogue scale | 3-month postoperative | 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. |
| 6-month postoperative degree of pain evaluated by visual analogue scale | 6-month postoperative | 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. |
| 12-month postoperative degree of pain evaluated by visual analogue scale | 12-month postoperative | 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. |
| 6-month postoperative spinal function evaluated by Oswestry Disability Index | 6-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. |
| 6-month postoperative degree of bone healing evaluated by plain radiograph | 6-month postoperative | Degree of bone healing evaluated by plain radiograph |
| 12-month postoperative degree of bone healing evaluated by plain radiograph | 12-month postoperative | Degree of bone healing evaluated by plain radiograph |
| 12-month postoperative degree of bone healing evaluated by computed tomograph | 12-month postoperative | Degree of bone healing evaluated by computed tomograph |
| 3-month postoperative degree of bone healing evaluated by plain radiograph | 3-month postoperative | Degree of bone healing evaluated by plain radiograph |
Countries
Taiwan
Contacts
Primary ContactMing-Hsien Hu, MD
Backup ContactPei-Yuan Lee, MD
Outcome results
None listed