Trials Sponsors Conditions Drugs Pricing

Conditions

Cervical Disc Degenerative Disorder

Keywords

Single LevelCervical Disc Disease

Outcome Measures

Primary Outcomes (1)

Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status
August 2010

Secondary Outcomes (1)

ROM; Fusion/migration of device; SF-36 imp of ≥15% at 24 months comp to Baseline; VAS imp of > 20 mm at 24 months comp to Baseline; Disc ht from lateral x-ray showing maintenance or imp from Baseline at 24
August 2010

Study Arms (2)

1

EXPERIMENTAL

NeoDisc

Device: NeoDisc

2

ACTIVE COMPARATOR

ACDF

Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)

Interventions

NeoDiscDevice

The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.

Instrumented Anterior Cervical Discectomy and Fusion (ACDF)Device

Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

years of age (inclusive and skeletally mature)
Diagnosis of symptomatic cervical disc disease, defined as image- confirmed pathology: herniated disc, spondylosis, and/or loss of disc height. Spondylosis is defined as MRI or CT-confirmed disc dessication, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25% less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining.

Sponsors & Collaborators

NuVasive
Industrylead

Study Sites (22)

San Diego Center for Spinal Disorders

La Jolla, California, 92037, United States

Diagnostic and Interventional Surgical Center

Marina del Rey, California, 90245, United States

The Spine Institute

Santa Monica, California, 90404, United States

Spine Colorado / Durango Orthopedic Associates

Durango, Colorado, 81301, United States

Rocky Mountain Spine Arthroplasty (RMA Ortho)

Loveland, Colorado, 80538, United States

Florida Spine Specialists

Fort Lauderdale, Florida, 33308, United States

Florida Research Network, LLC

Study Officials

Scott Kitchel, MD
Medical Monitor
PRINCIPAL INVESTIGATOR

Enrollment

488 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations