Degenerative Disc DiseasePhase 3NCT00215319
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
A Phase 3 study testing Lumbar I/F with cage and pedicle screws in people with Degenerative Disc Disease, run by DePuy Spine at 2 sites in United States.
Trial summary
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Lumbar I/F with cage and pedicle screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2000to Nov 2006
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
- Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1.
Who cannot join
- Abnormality at more than two levels,
- Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed,
- Infection in the disc or spine, past or present,
- Active infection at time of surgery,
- Tumor in the spine,
- Significant osteoporosis or metabolic bone disease,
- Greater than Grade I spondylolisthesis or significant bony defect in the lumbar spine,
- Pregnant or lactating, or wishes to become pregnant within duration of study,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
TSM Investigational Site A
Dothan, Alabama, 36301
TSM Investigational Site B
Fort Wayne, Indiana, 46825
About this study
Official title: A Multi-center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
Read the detailed description
This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1).
Study Success is as a compound endpoint requiring:
- Radiographic Fusion,
- Improvement in Pain/Function,
- Maintenance/Improvement in Neurologic Status, and
- Freedom from Secondary Surgical Intervention.
- The rate of Adverse Events must be no worse than in the control group as well.
Secondary Endpoints Include:
- Adverse Events
- SF-36 Health Related Quality of Life
- Disc Space Height
- Work Status
Comparison:
Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
- Conditions
- Degenerative Disc Disease
- Being tested
- Lumbar I/F with cage and pedicle screws
- Keywords
- Degenerative disc disease at up to 2 levels (L2-S1)
- 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.
Lumbar I/F with cage and pedicle screwsDevice
Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
| Study group | Role | What they receive |
|---|---|---|
| TSM Cage | Experimental | Lumbar I/F with cage and pedicle screws Receives: Device: Lumbar I/F with cage and pedicle screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
Oswestry Disability Index
Motor Function
Adverse Events
Secondary Surgical Interventions
Secondary outcomes (5)
SF-36
Graft site pain
Back pain
Leg pain
Disc space height
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2000
- Primary completionNov 2006
- Study completionNov 2006
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215319
- Sponsor's protocol ID
- G990313
- Status last verified
- May 2014
- First submitted
- 13 Sep 2005
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine
- ClinicalTrials.gov ID
- NCT00215319
- Acronym / sponsor ID
- G990313
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative disc disease at up to 2 levels (L2-S1)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Sep 2005 (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 purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
Detailed description
This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1).
Study Success is as a compound endpoint requiring:
- Radiographic Fusion,
- Improvement in Pain/Function,
- Maintenance/Improvement in Neurologic Status, and
- Freedom from Secondary Surgical Intervention.
- The rate of Adverse Events must be no worse than in the control group as well.
Secondary Endpoints Include:
- Adverse Events
- SF-36 Health Related Quality of Life
- Disc Space Height
- Work Status
Comparison:
Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSM Cage | Experimental | Device: Lumbar I/F with cage and pedicle screwsLumbar I/F with cage and pedicle screws |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
- Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1.
Key exclusion criteria (8 listed)
- Abnormality at more than two levels,
- Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed,
- Infection in the disc or spine, past or present,
- Active infection at time of surgery,
- Tumor in the spine,
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 I/F with cage and pedicle screwsSurgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws | Device | TSM Cage |
Primary outcome
Radiographic Fusion
Oswestry Disability Index
Motor Function
Adverse Events
Secondary Surgical Interventions
5 secondary outcomes
SF-36
Graft site pain
Back pain
Leg pain
Disc space height
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 23 May 2014.
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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.
2 sites 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 I/F with cage and pedicle screws in people with Degenerative Disc Disease, run by DePuy Spine at 2 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 2 inclusion and 8 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 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Radiographic Fusion. The study lists 5 primary outcomes in all. 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 23 May 2014.