Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

Pei-Yuan Lee, MD

Status: Unknown

Conditions: Bone Marrow; Spinal Fusion

Treatments: Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration; Other: Transforaminal lumbar interbody fusion with local bone graft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03793530

RD106050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Bone marrow concentration group

Experimental group

Description:

Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration

Treatment:

Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration

Control group

Active Comparator group

Description:

Transforaminal lumbar interbody fusion with local bone graft

Treatment:

Other: Transforaminal lumbar interbody fusion with local bone graft