Pseudarthrosis After Fusion or ArthrodesisNCT01409954
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
An observational study of Pseudarthrosis After Fusion or Arthrodesis, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudarthrosis After Fusion or Arthrodesis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Specialty clinic, University of Utah Orthopaedic Center
Who may be able to join
- Patients electing to undergo spinal decompression with an instrumented posterolateral fusion
Who cannot join
- Patients not undergoing spinal decompression with an instrumented posterolateral fusion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Defining the Osteogenic Potential of Mesenchymal Stem Cells and Their Progenitors During Spinal Decompression and Posterolateral Lumbar Fusion
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.
Read the 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.
- Keywords
- Fusion, Spine, Decompression, Pseudarthrosis, bone harvest, Instrumented posterolateral fusion
- Medical subject headings
- Ankylosis, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal decompression | Spinal decompression with an instrumented posterolateral fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteogenic Potential of Mesenchymal Stem Cells
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudarthrosis After Fusion or ArthrodesisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Lawrence, University of Utah
- Investigators
- Brandon Lawrence, MD, Principal investigator, University of Utah Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409954
- Sponsor's protocol ID
- 46970
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2011
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Osteogenic Potential of Mesenchymal Stem Cells and Their Progenitors During Spinal Decompression and Posterolateral Lumbar Fusion
- ClinicalTrials.gov ID
- NCT01409954
- Acronym / sponsor ID
- 46970
- Keywords
- Fusion, Spine, Decompression, Pseudarthrosis, bone harvest, Instrumented posterolateral fusion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal decompression | – | –Spinal decompression with an instrumented posterolateral fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specialty clinic, University of Utah Orthopaedic Center
Key inclusion criteria (1 listed)
- Patients electing to undergo spinal decompression with an instrumented posterolateral fusion
Key exclusion criteria (1 listed)
- Patients not undergoing spinal decompression with an instrumented posterolateral fusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Osteogenic Potential of Mesenchymal Stem Cells
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Lawrence, MD principal investigator
University of Utah Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudarthrosis After Fusion or Arthrodesis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteogenic Potential of Mesenchymal Stem Cells (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.