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

This study has been terminated.
(Study was stopped due to slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00762723
First received: September 26, 2008
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Device: Trinica Anterior Lumbar Plate System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    - Fusion Assessment


Enrollment: 19
Study Start Date: February 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762723

Locations
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, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00762723     History of Changes
Other Study ID Numbers: 2006-016
Study First Received: September 26, 2008
Results First Received: February 10, 2014
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
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:
Constriction, Pathologic
Spinal Diseases
Spinal Stenosis
Spondylolisthesis
Intervertebral Disk Degeneration
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on July 29, 2014