Degenerative Disc DiseaseNCT04566874
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
A study testing ALIF in people with Degenerative Disc Disease and Spinal Stenosis, run by Camber Spine Technologies at 2 sites in United States.
Trial summary
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- What is being tested?
- ALIF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2020to Jul 2021
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- skeletally mature adults
- completed 6 month non-operative or conservative therapy
- signed informed consent
- back pain with radicular symptoms as evidenced by leg pain
- Degenerative Disc Disease involving a single level between L2 and S1
- subject willing to participate in study and follow protocol
- subject willing to comply with Post-op management program
Who cannot join
- systemic infection such as AIDS, HIV or Active hepatitis
- autoimmune disease
- significant metabolic disease that might compromise bone growth
- history of malignancy
- previous surgery for primary tumor, trauma or infection
- subject requires 2 or more levels of fusion
- previous spinal instrumentation or previous interbody fusion at involved level
- spondylolisthesis of grade greater than/equal to 2
Trial locations and contacts
2 sites in 1 country.
Noel Hetrick contact
United States2 sites, 2 recruiting
- Recruiting
Rothman Orthopaedic Institure
Philadelphia, Pennsylvania, 19107
David Kaye, MD
- Recruiting
Texas Back Institute
Plano, Texas, 75093
Shannon Rusch, CCRC, 972-608-5143, srusch@texasback.com
About this study
Official title: SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
Read the detailed description
This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).
- Being tested
- ALIF
- Keywords
- lumbar spinal fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIFDevice
Anterior Lumbar Interbody Fusion
| Study group | Role | What they receive |
|---|---|---|
| Spira-A with HCT/p DBM | Other | Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM Receives: Device: ALIF |
| Medtronic PEEK ALIF with Infuse | Active comparator | Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse) Receives: Device: ALIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Measured: 6 months
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Measured: 12 months
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Measured: 24 months
Secondary outcomes (4)
Oswestry Disability Index
Improvement in the ODI as measured by a minimum of a 15 point improvement
Measured: up to and including 24 months
Back and Leg VAS
Improvement in the VAS as measured by a minimum of a 20 point improvement.
Measured: up to and including 24 months
VR-12 Health Survey
Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation
Measured: up to and including 24 months
PROMIS score
Change in the PROMIS score
Measured: up to and including 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start13 Jul 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind randomized 1:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camber Spine Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kaye, MD, Principal investigator, Rothman Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566874
- Sponsor's protocol ID
- SPA-2018
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: data to be share with investigators only.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2
- ClinicalTrials.gov ID
- NCT04566874
- Acronym / sponsor ID
- SPA-2018
- Keywords
- lumbar spinal fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Camber Spine TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- 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.
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
Detailed description
This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blind randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Spira-A with HCT/p DBM | Other | Device: ALIFSingle level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM |
| Medtronic PEEK ALIF with Infuse | Active comparator | Device: ALIFSingle level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse) |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- skeletally mature adults
- completed 6 month non-operative or conservative therapy
- signed informed consent
- back pain with radicular symptoms as evidenced by leg pain
- Degenerative Disc Disease involving a single level between L2 and S1
Key exclusion criteria (8 listed)
- systemic infection such as AIDS, HIV or Active hepatitis
- autoimmune disease
- significant metabolic disease that might compromise bone growth
- history of malignancy
- previous surgery for primary tumor, trauma or infection
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 |
|---|---|---|
| ALIFAnterior Lumbar Interbody Fusion | Device | Medtronic PEEK ALIF with Infuse, Spira-A with HCT/p DBM |
Primary outcome
Radiographic Fusion
Time frame: 6 months
AP/Lateral, Flexion, Extension and CT radiographs
Radiographic Fusion
Time frame: 12 months
AP/Lateral, Flexion, Extension and CT radiographs
Radiographic Fusion
Time frame: 24 months
AP/Lateral, Flexion, Extension and CT radiographs
4 secondary outcomes
Oswestry Disability Index
Time frame: up to and including 24 months
Back and Leg VAS
Time frame: up to and including 24 months
VR-12 Health Survey
Time frame: up to and including 24 months
PROMIS score
Time frame: up to and including 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No. data to be share with investigators only.
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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.
Noel Hetrick contact
David Kaye, MD principal investigator
Rothman Orthopaedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALIF in people with Degenerative Disc Disease and Spinal Stenosis, run by Camber Spine Technologies 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 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald W Guthner, BS (646.460.2984, dguthner@cambermedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Fusion (time frame: 6 months). The study lists 3 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 28 Sep 2020.