Degenerative Lumbar SpondylolisthesisNCT00678353
Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
An observational study of Degenerative Lumbar Spondylolisthesis, run by Olympus Biotech Corporation at 22 sites in 2 countries.
Trial summary
This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis
- How many people
- 202 participants
- Where
- 22 sitesin 2 countries
- Study dates
- May 2007to Aug 2007
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in clinical protocol S01-01US
Who may be able to join
- The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
- The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
- The patient agrees to complete the necessary clinical and radiographic evaluations.
Who cannot join
- 1. There are no exclusion criteria for participation in this protocol.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States19 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
New York, New York
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
Official title: Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.
Read the detailed description
Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft
- Conditions
- Degenerative Lumbar Spondylolisthesis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Follow-up to S01-01US, conducted to expand information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of bone by CT scan
Measured: 3+ years post-treatment from the Pivotal study S01-01US
Secondary outcomes (1)
Re-assessments of all clinical parameters from S01-01US
Measured: 3+ years post-treatment from the Pivotal study S01-01US
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 startMay 2007
- Study completionAug 2007
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Biotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678353
- Sponsor's protocol ID
- 06-UPLF-01
- 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
- Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
- ClinicalTrials.gov ID
- NCT00678353
- Acronym / sponsor ID
- 06-UPLF-01
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Keywords
- Degenerative disc disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Olympus Biotech CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Study completion
- Aug 2007 (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.
This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.
Detailed description
Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Follow-up to S01-01US, conducted to expand information |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in clinical protocol S01-01US
Key inclusion criteria (3 listed)
- The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
- The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
- The patient agrees to complete the necessary clinical and radiographic evaluations.
Key exclusion criteria (1 listed)
- 1. There are no exclusion criteria for participation in this protocol.
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
Evidence of bone by CT scan
Time frame: 3+ years post-treatment from the Pivotal study S01-01US
1 secondary outcome
Re-assessments of all clinical parameters from S01-01US
Time frame: 3+ years post-treatment from the Pivotal study S01-01US
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.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spondylolisthesis, run by Olympus Biotech Corporation at 22 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 3 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: 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 22 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?
Evidence of bone by CT scan (time frame: 3+ years post-treatment from the Pivotal study S01-01US). 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.