NCT00762723

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 26, 2014

Completed
Last Updated

April 17, 2014

Status Verified

March 1, 2014

Enrollment Period

4.6 years

First QC Date

September 26, 2008

Results QC Date

February 10, 2014

Last Update Submit

March 26, 2014

Conditions

Degenerative Disc DiseaseSpinal StenosisSpondylolisthesis

Keywords

Degenerative Disc DiseaseSpinal StenosisSpondylolisthesisALIFfusion successAnterior Lumbar Platefixed versus variable screw configurationsAnterior Lumbar Interbody Fusion to treat spinal instability

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)

    \- Fusion Assessment

    Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months

Study Arms (3)

Group 1

EXPERIMENTAL

Trinica Anterior Lumbar Plate System with fixed screws only

Device: Trinica Anterior Lumbar Plate System

Group 2

EXPERIMENTAL

Trinica Anterior Lumbar Plate System with variable screws only

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).

Device: Trinica Anterior Lumbar Plate System

Interventions

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.

Group 1Group 2Group 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alabama Spine Institute

Daphne, Alabama, 36526, United States

Location

Ronderos Neurosurgery Center

Mobile, Alabama, 36608, United States

Location

Loma Linda University Orthopedic Center

San Bernardino, California, 92408, United States

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal StenosisSpondylolisthesis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Results Point of Contact

Title
Laura Herdrich
Organization
Zimmer
laura.herdrich@zimmer.com
952-830-6224

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 17, 2014

Results First Posted

March 26, 2014

Record last verified: 2014-03

Locations

US(3)