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

Degenerative Disc Disease Clinical Trial

Official title:

A Comparison of Clinical Outcomes Comparing Fixed-angle, Variable-angle, and Hybrid Screw Configuration for the Trinica(R) Anterior Lumbar Plate System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00762723
• Other study ID #: 2006-016
• Status: Terminated
• Phase: N/A
• First received: September 26, 2008
• Last updated: March 26, 2014
• Start date: February 2008
• Est. completion date: September 2012

Study information

• Verified date: March 2014
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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".

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spondylolisthesis

Intervention

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.

Locations

Country	Name	City	State
United States	Alabama Spine Institute	Daphne	Alabama
United States	Ronderos Neurosurgery Center	Mobile	Alabama
United States	Loma Linda University Orthopedic Center	San Bernardino	California

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No