Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

NCT ID: NCT03793530

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-12-31

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.

Conditions

Bone Marrow; Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Bone marrow concentration group

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Control group

Transforaminal lumbar interbody fusion with local bone graft

Group Type: ACTIVE_COMPARATOR

Transforaminal lumbar interbody fusion with local bone graft

Intervention Type: OTHER

Transforaminal lumbar interbody fusion with local bone graft

Interventions

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

Intervention Type: OTHER

Transforaminal lumbar interbody fusion with local bone graft

Transforaminal lumbar interbody fusion with local bone graft

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeon Biotechnology Corporation

INDUSTRY

Sponsor Role: collaborator

Pei-Yuan Lee, MD

OTHER

Sponsor Role: lead

Responsible Party

Pei-Yuan Lee, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pei-Yuan Lee, MD

Role: STUDY_CHAIR

Show Chwan Memorial Hospital

Locations

Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Hsien Hu, MD

Role: CONTACT

minghsienhu@gmail.com

+886-975611289

Pei-Yuan Lee, MD

Role: CONTACT

Facility Contacts

Ming-Hsien Hu, MD

Role: primary

minghsienhu@gmail.com

+886-975611289

References

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.

Reference Type: DERIVED

PMID: 36401234 (View on PubMed)

Other Identifiers

RD106050

Identifier Type: -

Identifier Source: org_study_id