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Comparison of Posterior Cellular Bonegraft Options for Single Level Lumbar Spinal Fusion

NCT07187362 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-10-08

No results posted yet for this study

Summary

This study involves the assessment of alternatives to iliac bone graft during spinal fusion surgery. Four types of bone graft alternatives are being compared to iliac bone graft during the posterior portion of an anterior/posterior one-level lumbar spinal fusion. If you choose to participate in this study, you will be randomized (like a flip of a coin) to receive either your own iliac bone graft, bone morphogenetic protein (BMP, made from proteins found in the human body that stimulate bone growth), or one of the following stem-cell based bone graft alternatives for the posterior portion of your fusion surgery:

* Orthofix Trinity-made from donor bone and bone marrow stem cells
* Allosource Allostem-made from donor bone and fat stem cells
* Nutech Nucel-made from donor bone and placenta (after birth) stem cells

Each bone graft alternatives has been approved by the United States Food and Drug Administration (FDA) and is commercially available with the exception that BMP application is considered "off-label". That is, BMP it is not approved for this indication, it is currently indicated for anterior fusion. The volume of bone graft that you will receive is the same for each graph type (approximately 5cc). Approximately 150 patients from the Midwest Spine and Brain Institute are expected to be enrolled in this study. If you choose to take part, your participation will last about 2+ year.

At approximately 9 - 15 months after your surgery, you will be asked to return to the Midwest Spine and Brain Institute to undergo a limited CT scan of the fusion level to determine how you are healing. Your pain level and functional ability will also be evaluated at this visit.

Conditions

  • Disc Degenerative Disease
  • Spine Fusion for Degenerative Spine Disease

Interventions

BIOLOGICAL

Use iliac bone graft

BIOLOGICAL

use bone morphogenetic protein

BIOLOGICAL

use bone derived allograft MSCs

BIOLOGICAL

Use adipose tissue derived MSCs

BIOLOGICAL

Use amnion/placental derived MSCs

Sponsors & Collaborators

  • Midwest Spine & Brain Institute

    lead OTHER

Principal Investigators

  • Glenn R BUTTERMANN · Midwest Spine & Brain Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2019-08-02
Completion
2020-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187362 on ClinicalTrials.gov