Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells

NCT ID: NCT01409954

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2027-01-31

Brief Summary

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The purpose of this study is to improve fusion (bony healing) techniques and improve patient recovery by identifying cells in your body that make bone. Patients with spine problems often need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a slower recovery and may require revision (another) surgery. By using a small portion of the graft taken during surgery the investigators hope to define the cells that make bone most efficiently. This will help reduce the need for revision surgeries and improve patient recovery.

Detailed Description

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This study requests using your additional bone tissue (the extra tissue not needed after your back surgery is complete).

This tissue will be measured for total volume (amount), labeled with your age, gender, date and time the tissue was removed (date and time of surgery), and taken to a lab for analysis. You will not be billed for the collection of your additional tissue or the lab analysis. All routine procedures (surgery and all follow-up care relating to your back surgery) will still be paid for by you or your insurance.

Once your extra tissue sample has been collected, measured, labeled, and sent to the lab for testing, no further participation is required from you in this research study. The investigators will use your sample in our research to enhance bone healing.

Conditions

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Pseudarthrosis After Fusion or Arthrodesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal decompression

Spinal decompression with an instrumented posterolateral fusion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients electing to undergo spinal decompression with an instrumented posterolateral fusion

Exclusion Criteria

* Patients not undergoing spinal decompression with an instrumented posterolateral fusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Brandon Lawrence

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon Lawrence, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Department of Orthopaedics

Locations

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University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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46970

Identifier Type: -

Identifier Source: org_study_id

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