Clinical trial NCT03793530: Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery
Official title: The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Marrow
Spinal Fusion
Keywords: Bone Marrow
Mesenchymal Stromal Cells
spine fusion surgery
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2019-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-month postoperative spinal function evaluated by Oswestry Disability Index
timeFrame: 3-month postoperative
Secondary outcomes:
measure: 6-month postoperative spinal function evaluated by Oswestry Disability Index
timeFrame: 6-month postoperative
measure: 12-month postoperative spinal function evaluated by Oswestry Disability Index
timeFrame: 12-month postoperative
measure: 3-month postoperative degree of pain evaluated by visual analogue scale
timeFrame: 3-month postoperative
measure: 6-month postoperative degree of pain evaluated by visual analogue scale
timeFrame: 6-month postoperative
measure: 12-month postoperative degree of pain evaluated by visual analogue scale
timeFrame: 12-month postoperative
measure: 3-month postoperative degree of bone healing evaluated by plain radiograph
timeFrame: 3-month postoperative
measure: 6-month postoperative degree of bone healing evaluated by plain radiograph
timeFrame: 6-month postoperative
measure: 12-month postoperative degree of bone healing evaluated by plain radiograph
timeFrame: 12-month postoperative
measure: 12-month postoperative degree of bone healing evaluated by computed tomograph
timeFrame: 12-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References:
citation: 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.