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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Fusion; Bone Marrow
• Intervention / Treatment: Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration; Other: Transforaminal lumbar interbody fusion with local bone graft

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Recruiting
      • Show Chwan Memorial Hospital
      • Contact: Ming-Hsien Hu, MD; Phone Number: +886-975611289; Email: minghsienhu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bone marrow concentration group; Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration	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
ACTIVE_COMPARATOR: Control group; Transforaminal lumbar interbody fusion with local bone graft	Other: Transforaminal lumbar interbody fusion with local bone graft; Transforaminal lumbar interbody fusion with local bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month postoperative spinal function evaluated by Oswestry Disability Index	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month postoperative spinal function evaluated by Oswestry Disability Index	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
12-month postoperative spinal function evaluated by Oswestry Disability Index	Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.	12-month postoperative
3-month postoperative degree of pain evaluated by visual analogue scale	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.	3-month postoperative
6-month postoperative degree of pain evaluated by visual analogue scale	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
12-month postoperative degree of pain evaluated by visual analogue scale	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
3-month postoperative degree of bone healing evaluated by plain radiograph	Degree of bone healing evaluated by plain radiograph	3-month postoperative
6-month postoperative degree of bone healing evaluated by plain radiograph	Degree of bone healing evaluated by plain radiograph	6-month postoperative
12-month postoperative degree of bone healing evaluated by plain radiograph	Degree of bone healing evaluated by plain radiograph	12-month postoperative
12-month postoperative degree of bone healing evaluated by computed tomograph	Degree of bone healing evaluated by computed tomograph	12-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (ACTUAL): January 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Mesenchymal Stromal Cells; Bone Marrow; spine fusion surgery
• Other Study ID Numbers: RD106050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No