NCT03793530

Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pei-Yuan Lee, MD · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Marrow
• Spinal Fusion

Interventions

Type	Name	Description
OTHER	Transforaminal 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
OTHER	Transforaminal lumbar interbody fusion with local bone graft	Transforaminal lumbar interbody fusion with local bone graft

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-01-04
• Last updated: 2020-04-14

Locations

1 site across 1 country: Taiwan