Degenerative Lumbar SpondylolisthesisNCT00677950
OP-1 Putty for Posterolateral Fusions
A study testing Spinal fusion in people with Degenerative Lumbar Spondylolisthesis, run by Olympus Biotech Corporation at 24 sites in 2 countries.
Trial summary
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis
- What is being tested?
- Spinal fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Oct 2001to Nov 2005
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
- The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
- The subject requires one level lumbar fusion (L-3 to S-1).
- The subject has a preoperative Oswestry Disability Index of 30-100.
Who cannot join
- The subject has active spinal and/or systemic infection.
- The subject is morbidly obese.
- The subject has a known sensitivity to any component of the OP-1 Putty.
- The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
- The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States21 sites
Study site
Akron, Ohio
Study site
Charlotte, North Carolina
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Clearwater, Florida
Study site
Denver, Colorado
Study site
Fairfax, Virginia
Study site
Fort Lauderdale, Florida
Study site
Germantown, Tennessee
Study site
Kalamazoo, Michigan
Study site
Miami, Florida
Study site
New York, New York
Study site
Newark, Delaware
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
Santa Monica, California
Study site
Southfield, Michigan
Study site
St Louis, Missouri
Study site
Stanford, California
Canada3 sites
Study site
Halifax, Nova Scotia
Study site
London, Ontario
Study site
Toronto, Ontario
About this study
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
Read the detailed description
A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Being tested
- Spinal fusion
- Keywords
- Degenerative Disc Disease
- 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
Also called Lumbar Spinal Fusion
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OP-1 Putty Receives: Procedure: Spinal fusion |
| 2 | Active comparator | Autograft Receives: Procedure: Spinal fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
Measured: 3, 6, 12, 24 months
Secondary outcomes (1)
The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startOct 2001
- Primary completionNov 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar SpondylolisthesisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Biotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677950
- Sponsor's protocol ID
- S01-01US
- Status last verified
- Jun 2011
- First submitted
- 13 May 2008
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OP-1 Putty for Posterolateral Fusions
- ClinicalTrials.gov ID
- NCT00677950
- Acronym / sponsor ID
- S01-01US
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Keywords
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Olympus Biotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 15 May 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.
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
Detailed description
A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Spinal fusionOP-1 Putty |
| 2 | Active comparator | Procedure: Spinal fusionAutograft |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
- The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
- The subject requires one level lumbar fusion (L-3 to S-1).
- The subject has a preoperative Oswestry Disability Index of 30-100.
Key exclusion criteria (5 listed)
- The subject has active spinal and/or systemic infection.
- The subject is morbidly obese.
- The subject has a known sensitivity to any component of the OP-1 Putty.
- The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
- The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
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 fusionAlso: Lumbar Spinal FusionSurgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis | Procedure or surgery | 1, 2 |
Primary outcome
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
Time frame: 3, 6, 12, 24 months
1 secondary outcome
The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use
Time frame: 3, 6, 12, 24 months
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 10 Jun 2011.
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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.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal fusion in people with Degenerative Lumbar Spondylolisthesis, run by Olympus Biotech Corporation at 24 sites in 2 countries.
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 4 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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.
What does the primary outcome measure?
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations (time frame: 3, 6, 12, 24 months). 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 10 Jun 2011.