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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD | Clinical Trials | Clareo Health

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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease

NCT00667459•Medtronic Spinal and Biologics

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Detailed Description

This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
•One level requiring surgical treatment
•C3-C4 disc to C6-C7 disc level involvement
•Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
•No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
•Preop Neck Disability index score ≥ 30
•Preop Neck Pain score of ≥ 20 based on the Preop Neck \& Arm Pain Questionnaire
•Not pregnant at time of surgery
•Willing and able to comply with study plan and able to understand and sign patient informed consent

Exclusion Criteria

•Any other cervical spinal condition requiring surgical treatment at the involved level
•Documented or diagnosed cervical instability defined by radiographs showing
•1. Sagittal plane translation \> 3.5mm or
•2. Sagittal plane angulation \> 20 degrees.
•More than one cervical level requiring surgery
•A fused level adjacent to the level to be treated
•Severe pathology of the facet joint of involved bodies
•Previous surgery at the involved level
•Previously diagnosed osteopenia or osteomalacia
•Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)
+19 more criteria

Locations (16)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

The Hughston Clinic, P.C.

Columbus, Georgia, United States

Coeur d'Alene Spine and Brain, PLLC

Coeur d'Alene, Idaho, United States

Central Illinois Neuroscience

Bloomington, Illinois, United States

Indiana Spine

Carmel, Indiana, United States

OrthoIndy

Indianapolis, Indiana, United States

Cedar Neurological Surgeons, PC

Cedar Rapids, Iowa, United States

Sports Medicine North

Peabody, Massachusetts, United States

The Orthopaedic Center of St. Louis

Chesterfield, Missouri, United States

Springfield Neurological Institute

Springfield, Missouri, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

January 1, 2008

Completion Date

June 1, 2014

Last Updated

June 6, 2023

Enrollment

280

ACTUAL participants

Conditions

Cervical Degenerative Disc Disease

Interventions

PRESTIGE® LP Cervical Disc

DEVICE

ATLANTIS Anterior Cervical Plate

DEVICE

Real World Data Collection on the Synergy Disc

NCT06383949

Cervical Degenerative Disc Disease

View study

RECRUITING

Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

NCT05880823

Cervical Degenerative Disc Disease

View study

ACTIVE_NOT_RECRUITINGNA

The Synergy Disc To Anterior Cervical Discectomy and Fusion

NCT04469231

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Inclusion Criteria

Exclusion Criteria

Real World Data Collection on the Synergy Disc

Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

The Synergy Disc To Anterior Cervical Discectomy and Fusion

M6-C Post Approval Study (PAS)

Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion

Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy