Degenerative Disc DiseaseNCT00762723
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
A study testing Trinica Anterior Lumbar Plate System in people with Degenerative Disc Disease and Spinal Stenosis, run by Zimmer Biomet at 3 sites in United States.
Trial summary
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- What is being tested?
- Trinica Anterior Lumbar Plate System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Spinal stenosis
- Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Fracture (including dislocation or subluxation)
- Spine tumor
- Scoliosis
- Lordotic deformities of the spine
Who cannot join
- An active systemic or local infection
- Previous fusion attempt at index level
- A local inflammation with or without fever or leukocytosis
- Pregnancy
- Obesity (BMI >40 kg/m2)
- Drug or alcohol abuse
Show all 12Show fewer
- Uncooperativeness or neurological or mental illness rendering the individual unwilling or unable to follow instructions
- Inability to restrict high activity level
- A suspected or documented metal allergy or intolerance
- A poor prognosis for good wound healing (e.g., decubitus ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition)
- Any medical or surgical condition that would preclude the potential benefit of spinal implant surgery, prevent secure component fixation, or seriously increase the risk of tolerating any surgical procedure,
- Any other "contraindications" as enumerated in the device's "Instructions for Use".
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alabama Spine Institute
Daphne, Alabama, 36526
Ronderos Neurosurgery Center
Mobile, Alabama, 36608
Loma Linda University Orthopedic Center
San Bernardino, California, 92408
About this study
Official title: A Comparison of Clinical Outcomes Comparing Fixed-angle, Variable-angle, and Hybrid Screw Configuration for the Trinica(R) Anterior Lumbar Plate System
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The device's bone-plate interface is enhanced through use of fixed-angled screws,variable-angle screws or a combination of both to accommodate various combinations of screw configurations, resulting in enhanced fixation tailored to individual patient needs. Clinical outcomes data, including a comparison of different screw configurations, is needed to support the use and of the Trinica ALP System.
Read the detailed description
In the cervical spine, literature shows that a static plate utilizing fixed screws loses its ability to load share and to limit motion following subsidence of the interbody spacer. In contrast, a dynamic plate system utilizing variable-angle screws maintains load-sharing and stiffness following subsidences. Increasing the load on the bone graft in the interbody space increases the rate of graft fusion. Although literature exists supporting the in vivo use of anterior cervical plate systems and the advantages of screw angulation, there is no data evaluating and supporting the use of anterior plate systems in the lumbar spine. The different biomechanical loads between cervical and lumbar spine suggest cervical data may not generalize to the lumbar spine. Additionally, it will be useful to characterize the effect of different screw configurations on subsidence and stress shielding and fusion success. The proposed study will not only assess clinical outcomes following Trinica ALP implantation, but will also provide valuable comparison data regarding two different screw configurations.
The study is a prospective, randomized, between groups design. The subject pool will be comprised of individuals who are appropriate for spinal fusion surgery, and who meet the inclusion criteria. Subjects will be randomly assigned to one of three screw configurations. All subjects will receive structural allograft (Puros A Anterior Allograft) as interbody support. Other procedures identified by the surgeon to be in the best interest of the patient may be completed but are not required by the protocol.
- Being tested
- Trinica Anterior Lumbar Plate System
- Keywords
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, ALIF, fusion success, Anterior Lumbar Plate, fixed versus variable screw configurations, Anterior Lumbar Interbody Fusion to treat spinal instability
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trinica Anterior Lumbar Plate SystemDevice
Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Trinica Anterior Lumbar Plate System with fixed screws only Receives: Device: Trinica Anterior Lumbar Plate System |
| Group 2 | Experimental | Trinica Anterior Lumbar Plate System with variable screws only Receives: Device: Trinica Anterior Lumbar Plate System |
| Group 3 | Experimental | Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws). Receives: Device: Trinica Anterior Lumbar Plate System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)
- Fusion Assessment
Measured: Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, 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 posted30 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Study was stopped due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762723
- Sponsor's protocol ID
- 2006-016
- Status last verified
- Mar 2014
- First submitted
- 26 Sep 2008
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Clinical Outcomes Comparing Fixed-angle, Variable-angle, and Hybrid Screw Configuration for the Trinica(R) Anterior Lumbar Plate System
- ClinicalTrials.gov ID
- NCT00762723
- Acronym / sponsor ID
- 2006-016
- Keywords
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, ALIF, fusion success, Anterior Lumbar Plate, fixed versus variable screw configurations, Anterior Lumbar Interbody Fusion to treat spinal instability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to slow enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The device's bone-plate interface is enhanced through use of fixed-angled screws,variable-angle screws or a combination of both to accommodate various combinations of screw configurations, resulting in enhanced fixation tailored to individual patient needs. Clinical outcomes data, including a comparison of different screw configurations, is needed to support the use and of the Trinica ALP System.
Detailed description
In the cervical spine, literature shows that a static plate utilizing fixed screws loses its ability to load share and to limit motion following subsidence of the interbody spacer. In contrast, a dynamic plate system utilizing variable-angle screws maintains load-sharing and stiffness following subsidences. Increasing the load on the bone graft in the interbody space increases the rate of graft fusion. Although literature exists supporting the in vivo use of anterior cervical plate systems and the advantages of screw angulation, there is no data evaluating and supporting the use of anterior plate systems in the lumbar spine. The different biomechanical loads between cervical and lumbar spine suggest cervical data may not generalize to the lumbar spine. Additionally, it will be useful to characterize the effect of different screw configurations on subsidence and stress shielding and fusion success. The proposed study will not only assess clinical outcomes following Trinica ALP implantation, but will also provide valuable comparison data regarding two different screw configurations.
The study is a prospective, randomized, between groups design. The subject pool will be comprised of individuals who are appropriate for spinal fusion surgery, and who meet the inclusion criteria. Subjects will be randomly assigned to one of three screw configurations. All subjects will receive structural allograft (Puros A Anterior Allograft) as interbody support. Other procedures identified by the surgeon to be in the best interest of the patient may be completed but are not required by the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Trinica Anterior Lumbar Plate SystemTrinica Anterior Lumbar Plate System with fixed screws only |
| Group 2 | Experimental | Device: Trinica Anterior Lumbar Plate SystemTrinica Anterior Lumbar Plate System with variable screws only |
| Group 3 | Experimental | Device: Trinica Anterior Lumbar Plate SystemTrinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Spinal stenosis
- Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Fracture (including dislocation or subluxation)
- Spine tumor
- Scoliosis
Key exclusion criteria (12 listed)
- An active systemic or local infection
- Previous fusion attempt at index level
- A local inflammation with or without fever or leukocytosis
- Pregnancy
- Obesity (BMI >40 kg/m2)
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 |
|---|---|---|
| Trinica Anterior Lumbar Plate SystemTrinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration. | Device | Group 1, Group 2, Group 3 |
Primary outcome
Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)
Time frame: Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months
- Fusion Assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trinica Anterior Lumbar Plate System in people with Degenerative Disc Disease and Spinal Stenosis, run by Zimmer Biomet at 3 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 6 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: stopped early, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment) (time frame: Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, 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 17 Apr 2014.