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

• Conditions: Pseudarthrosis After Fusion or Arthrodesis

• Registration Number: NCT01409954
• Lead Sponsor: University of Utah

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Study Start: 2011-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Read More

Exclusion Criteria

• Patients not undergoing spinal decompression with an instrumented posterolateral fusion

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteogenic Potential of Mesenchymal Stem Cells	21 days

Trial Locations

Locations (1)

University of Utah Orthopaedic Center; 🇺🇸 Salt Lake City, Utah, United States