Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
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.
Pseudarthrosis After Fusion or Arthrodesis
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Defining the Osteogenic Potential of Mesenchymal Stem Cells and Their Progenitors During Spinal Decompression and Posterolateral Lumbar Fusion|
- Osteogenic Potential of Mesenchymal Stem Cells [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Aliquots of bone marrow aspirates and bone fragments
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Spinal decompression with an instrumented posterolateral fusion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409954
|United States, Utah|
|University of Utah Orthopaedic Center|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Brandon Lawrence, MD||University of Utah Department of Orthopaedics|