Degenerative Disc DiseaseFACTNCT00736398
Fusion Assessment Clinical Trial
An observational study of Degenerative Disc Disease, run by Flexuspine, Inc. at 6 sites in United States.
Trial summary
This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Spinal fusion
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring spinal fusion
Who may be able to join
- Lumbar DDD
- Candidate for spinal fusion
- Provide written informed consent
Who cannot join
- Prior lumbar spinal fusion
- Metabolic bone disease
- Morbid obesity
- Systemic infection or active malignancy
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Greater Baltimore Medica Center
Baltimore, Maryland, 21204
MUSC
Charleston, South Carolina, 29425
Florida Spine Institute
Clearwater, Florida, 33765
Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, 33637
Guy Danielson, M.D.
Tyler, Texas, 75701
The Washington Hospital
Washington, Pennsylvania, 15301
About this study
Official title: Fusion Assessment Clinical Trial (FACT)
This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.
- Conditions
- Degenerative Disc Disease
- Being tested
- Spinal fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal fusionProcedure or surgery
Spinal fusion
| Study group | Role | What they receive |
|---|---|---|
| Observation | Spinal fusion Receives: Procedure: Spinal fusion |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flexuspine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736398
- Sponsor's protocol ID
- 01000-T02
- Acronym
- FACT
- Status last verified
- Apr 2013
- First submitted
- 14 Aug 2008
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion Assessment Clinical Trial (FACT)
- ClinicalTrials.gov ID
- NCT00736398
- Acronym / sponsor ID
- FACT / 01000-T02
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Flexuspine, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- First posted
- 15 Aug 2008 (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.
This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Procedure: Spinal fusionSpinal fusion |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring spinal fusion
Key inclusion criteria (3 listed)
- Lumbar DDD
- Candidate for spinal fusion
- Provide written informed consent
Key exclusion criteria (5 listed)
- Prior lumbar spinal fusion
- Metabolic bone disease
- Morbid obesity
- Systemic infection or active malignancy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal fusionSpinal fusion | Procedure or surgery | Observation |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Flexuspine, Inc. at 6 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Apr 2013.