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Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws

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ClinicalTrials.gov Identifier: NCT00762723
Recruitment Status : Terminated (Study was stopped due to slow enrollment)
First Posted : September 30, 2008
Results First Posted : March 26, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Device: Trinica Anterior Lumbar Plate System Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Clinical Outcomes Comparing Fixed-angle, Variable-angle, and Hybrid Screw Configuration for the Trinica(R) Anterior Lumbar Plate System
Study Start Date : February 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Trinica Anterior Lumbar Plate System with fixed screws only
 Device: Trinica Anterior Lumbar Plate System
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.
Experimental: Group 2
Trinica Anterior Lumbar Plate System with variable screws only
 Device: Trinica Anterior Lumbar Plate System
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.
Experimental: Group 3
Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).
 Device: Trinica Anterior Lumbar Plate System
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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".
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762723


Locations
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United States, Alabama
Alabama Spine Institute
Daphne, Alabama, United States, 36526
Ronderos Neurosurgery Center
Mobile, Alabama, United States, 36608
United States, California
Loma Linda University Orthopedic Center
San Bernardino, California, United States, 92408
Sponsors and Collaborators
Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00762723    
Other Study ID Numbers: 2006-016
First Posted: September 30, 2008    Key Record Dates
Results First Posted: March 26, 2014
Last Update Posted: April 17, 2014
Last Verified: March 2014
Keywords provided by Zimmer Biomet:
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
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
 Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis