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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Brandon Lawrence, University of Utah
ClinicalTrials.gov Identifier:
NCT01409954
First received: August 2, 2011
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition
Pseudarthrosis After Fusion or Arthrodesis

Study Type: Observational
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

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 60
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)
Groups/Cohorts
Spinal decompression
Spinal decompression with an instrumented posterolateral fusion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Specialty clinic, University of Utah Orthopaedic Center

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409954

Locations
United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Brandon Lawrence, MD University of Utah Department of Orthopaedics
  More Information

No publications provided

Responsible Party: Brandon Lawrence, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01409954     History of Changes
Other Study ID Numbers: 46970
Study First Received: August 2, 2011
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Fusion
Spine
Decompression
Pseudarthrosis
bone harvest
Instrumented posterolateral fusion

Additional relevant MeSH terms:
Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014