Degenerative Lumbar SpondylolisthesisNCT00679107
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
A study testing Use of OP-1 Putty in Uninstrumented posterolateral fusion in people with Degenerative Lumbar Spondylolisthesis, run by Olympus Biotech Corporation at 5 sites in United States.
Trial summary
This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis
- What is being tested?
- Use of OP-1 Putty in Uninstrumented posterolateral fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 1999to Jul 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 81 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Akron, Ohio
Study site
Chicago, Illinois
Study site
New Haven, Connecticut
Study site
Philadelphia, Pennsylvania
Study site
Royal Oak, Michigan
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
Read the detailed description
It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Being tested
- Use of OP-1 Putty in Uninstrumented posterolateral 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.
Use of OP-1 Putty in Uninstrumented posterolateral fusionDevice
Also called Uninstrumented posterolateral fusion
Use of OP-1 Putty in Uninstrumented posterolateral fusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | autogenous bone graft with the addition of OP-1 Putty Receives: Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion |
| 2 | Active comparator | autogenous bone graft alone Receives: Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
Measured: 6 weeks; 3, 6, 9, 12, and 24 months
Secondary outcomes (1)
Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).
Measured: 6 weeks; 3, 6, 9, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startJun 1999
- Primary completionDec 2000
- Study completionJul 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Biotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679107
- Sponsor's protocol ID
- S99-01US
- 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
- A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
- ClinicalTrials.gov ID
- NCT00679107
- Acronym / sponsor ID
- S99-01US
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Keywords
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Olympus Biotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Dec 2000 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 16 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 will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
Detailed description
It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Use of OP-1 Putty in Uninstrumented posterolateral fusionautogenous bone graft with the addition of OP-1 Putty |
| 2 | Active comparator | Device: Use of OP-1 Putty in Uninstrumented posterolateral fusionautogenous bone graft alone |
Who may qualify
- Ages
- 18 to 81 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 |
|---|---|---|
| Use of OP-1 Putty in Uninstrumented posterolateral fusionAlso: Uninstrumented posterolateral fusionUse of OP-1 Putty in Uninstrumented posterolateral fusion | Device | 1, 2 |
Primary outcome
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
Time frame: 6 weeks; 3, 6, 9, 12, and 24 months
1 secondary outcome
Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).
Time frame: 6 weeks; 3, 6, 9, 12, and 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of OP-1 Putty in Uninstrumented posterolateral fusion in people with Degenerative Lumbar Spondylolisthesis, run by Olympus Biotech Corporation at 5 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 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 5 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.
What does the primary outcome measure?
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone). (time frame: 6 weeks; 3, 6, 9, 12, and 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.