Lumbar FusionPhase 3NCT00620399
A Study on the Use of a Brace Following Low Back Surgery
A Phase 3 study testing lumbar corset in people with Lumbar Fusion, run by Sunnybrook Health Sciences Centre at 1 site in United States.
Trial summary
This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Fusion
- What is being tested?
- lumbar corset
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1996to Jun 2003
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Undergoing posterior lumbar fusion surgery for degenerative conditions
Who cannot join
- Unable to complete questionnaires due to language or cognitive barrier
- Declined study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study
This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery
- Conditions
- Lumbar Fusion
- Being tested
- lumbar corset
- Keywords
- lumbar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar corsetOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | brace Receives: Other: lumbar corset |
| 2 | Placebo comparator | no brace Receives: Other: lumbar corset |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome scores
Measured: 2 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startMay 1996
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar FusionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Sofamor Danek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620399
- Sponsor's protocol ID
- 019511
- Status last verified
- Apr 2020
- First submitted
- 11 Feb 2008
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00620399
- Acronym / sponsor ID
- 019511
- Conditions
- Lumbar Fusion
- Keywords
- lumbar fusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Medtronic Sofamor Danek
- Study start
- May 1996
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 21 Feb 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 study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: lumbar corsetbrace |
| 2 | Placebo comparator | Other: lumbar corsetno brace |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80
- Undergoing posterior lumbar fusion surgery for degenerative conditions
Key exclusion criteria (2 listed)
- Unable to complete questionnaires due to language or cognitive barrier
- Declined study participation
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 |
|---|---|---|
| lumbar corset | Other | 1, 2 |
Primary outcome
functional outcome scores
Time frame: 2 years following surgery
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 20 Apr 2020.
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Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lumbar corset in people with Lumbar Fusion, run by Sunnybrook Health Sciences Centre 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 2 inclusion and 2 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 20 Apr 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
functional outcome scores (time frame: 2 years following surgery). 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 20 Apr 2020.