Disc Degeneration of Pfirrmann Grade III or GreaterSNAPNCT01557829
Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial
A study testing Posterior lumbar interbody fusion with a PEEK cage and Posterior lumbar interbody fusion with a Valeo OL cage in people with Disc Degeneration of Pfirrmann Grade III or Greater and Degenerative Spondylolisthesis, run by Amedica Corporation at 2 sites in Netherlands.
Trial summary
This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or II
- What is being tested?
- Posterior lumbar interbody fusion with a PEEK cage and Posterior lumbar interbody fusion with a Valeo OL cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2012to Mar 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age 18-75 years
- Chronic low back pain unresponsive to at least six months of conservative care
- MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II
Who cannot join
- Osteoporosis
- Patients with prior failed fusion at the same level
- Degenerative scoliosis
- Degenerative spondylolisthesis greater than Grade II
- Pregnancy
- Psychiatric or mental disease
Show all 12Show fewer
- Alcoholism (drinking more than 5 units per day)
- Active infection or prior infection at the surgical site
- Active cancer
- Insufficient language skills to complete questionnaires
- Participation in another study
- More than two symptomatic levels that need fusion
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medical Center Haaglanden
The Hague, 2501 CK
Diakonessenhuis
Utrecht
About this study
Official title: Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
- Conditions
- Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or II
- Being tested
- Posterior lumbar interbody fusion with a PEEK cage, Posterior lumbar interbody fusion with a Valeo OL cage
- Keywords
- spondylolisthesis, disc degeneration, lumbar interbody fusion, randomized controlled trial, ceramic interbody spacer
- Medical subject headings
- Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior lumbar interbody fusion with a PEEK cageDevice
Also called Amedica Phantom Plus or Pioneer Bullet-Tip cage
PEEK cage suitable for oblique placement in the lumbar spine
Posterior lumbar interbody fusion with a Valeo OL cageDevice
Also called Valeo OL, silicon nitride ceramic
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
| Study group | Role | What they receive |
|---|---|---|
| PEEK interbody cage | Active comparator | Posterior fusion with an interbody spacer (cage) made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is filled with local bone or bone harvested from the iliac crest. Receives: Device: Posterior lumbar interbody fusion with a PEEK cage |
| Valeo OL ceramic cage | Experimental | Posterior fusion with the Valeo OL cage, a silicon nitride ceramic interbody spacer. The center area of the cage is filled with autograft local bone or bone harvested from the iliac crest. Receives: Device: Posterior lumbar interbody fusion with a Valeo OL cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire (RMDQ)
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
Measured: 12 months post-op
Secondary outcomes (2)
Fusion status
Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.
Measured: 3 mo., 6 mo., 12 mo., 24 months
Oswestry Disability Index (ODI)
The improvement in the ODI over the pre-op ODI for each Group
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disc Degeneration of Pfirrmann Grade III or GreaterStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amedica Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557829
- Sponsor's protocol ID
- Amedica 2011-9
- Other IDs
- NL34808.100.10
- Acronym
- SNAP
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kersten RF, van Gaalen SM, Arts MP, Roes KC, de Gast A, Corbin TP, Oner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord. 2014 Feb 25;15:57. doi: 10.1186/1471-2474-15-57.
PubMed 24568365
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT01557829
- Acronym / sponsor ID
- SNAP / Amedica 2011-9
- Conditions
- Disc Degeneration of Pfirrmann Grade III or Greater, Degenerative Spondylolisthesis, Isthmic Spondylolisthesis of Grade I or II
- Keywords
- spondylolisthesis, disc degeneration, lumbar interbody fusion, randomized controlled trial, ceramic interbody spacer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amedica CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Mar 2012 (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 randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK interbody cage | Active comparator | Device: Posterior lumbar interbody fusion with a PEEK cagePosterior fusion with an interbody spacer (cage) made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is filled with local bone or bone harvested from the iliac crest. |
| Valeo OL ceramic cage | Experimental | Device: Posterior lumbar interbody fusion with a Valeo OL cagePosterior fusion with the Valeo OL cage, a silicon nitride ceramic interbody spacer. The center area of the cage is filled with autograft local bone or bone harvested from the iliac crest. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients age 18-75 years
- Chronic low back pain unresponsive to at least six months of conservative care
- MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II
Key exclusion criteria (12 listed)
- Osteoporosis
- Patients with prior failed fusion at the same level
- Degenerative scoliosis
- Degenerative spondylolisthesis greater than Grade II
- Pregnancy
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 |
|---|---|---|
| Posterior lumbar interbody fusion with a PEEK cageAlso: Amedica Phantom Plus or Pioneer Bullet-Tip cagePEEK cage suitable for oblique placement in the lumbar spine | Device | PEEK interbody cage |
| Posterior lumbar interbody fusion with a Valeo OL cageAlso: Valeo OL, silicon nitride ceramicPosterior lumbar interbody fusion with a single Valeo OL ceramic cage. | Device | Valeo OL ceramic cage |
Primary outcome
Roland Morris Disability Questionnaire (RMDQ)
Time frame: 12 months post-op
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
2 secondary outcomes
Fusion status
Time frame: 3 mo., 6 mo., 12 mo., 24 months
Oswestry Disability Index (ODI)
Time frame: 12 months post-op
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 4 Apr 2017.
- Derived from this study: PubMed 24568365Kersten RF, van Gaalen SM, Arts MP, Roes KC, de Gast A, Corbin TP, Oner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord. 2014 Feb 25;15:57. doi: 10.1186/1471-2474-15-57.
- Individual participant dataSharing planned: No
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 study testing Posterior lumbar interbody fusion with a PEEK cage and Posterior lumbar interbody fusion with a Valeo OL cage in people with Disc Degeneration of Pfirrmann Grade III or Greater and Degenerative Spondylolisthesis, run by Amedica Corporation at 2 sites in Netherlands.
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 12 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 4 Apr 2017. 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 Netherlands. 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?
Roland Morris Disability Questionnaire (RMDQ) (time frame: 12 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557829, which also lists 1 linked publication.
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 4 Apr 2017.