Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study) - Full Text View

Sponsor:	DePuy Spine
Information provided by:	DePuy Spine
ClinicalTrials.gov Identifier:	NCT00432159

Purpose

The purpose of this study is to determine the safety and effectiveness of the DISCOVER Artificial Cervical Disc in the treatment of degenerative disc disease in one level in the cervical spine.

Condition	Intervention
Cervical Degenerative Disc Disease	Device: Arthroplasty (DISCOVER™ Artificial Cervical Disc) Device: ACDF (allograft with SLIM LOC® Anterior Cervical Plate System)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease

Further study details as provided by DePuy Spine:

Primary Outcome Measures:

Neck Disability Index [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Significant permanent abnormalities in neurological function [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Subsequent secondary surgical interventions at the index level(s) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Device related serious adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disc and foraminal height [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Global cervical range of motion [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Sagittal angulation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Adjacent level degeneration and/or disease [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Pain measured by Visual Analogue Scale [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Quality of Life by SF-36 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Dysphagia Disability Index [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Patient Satisfaction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Work Status Assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	550
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DISCOVER DISCOVER™ Artificial Cervical Disc	Device: Arthroplasty (DISCOVER™ Artificial Cervical Disc) DISCOVER Artificial Cervical Disc
Active Comparator: SLIM-Loc Allograft with SLIM-LOC™ Anterior Cervical Plate System	Device: ACDF (allograft with SLIM LOC® Anterior Cervical Plate System) SLIM Loc

Detailed Description:

This study is designed as a multi-center, prospective, randomized, controlled trial. Subjects will be randomized using a 1:1 ratio. Participants in the treatment group will receive the DISCOVER Artificial Cervical Disc. Participants in the control group will receive fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, 2, 3, 4 and 5 years post-surgery.

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
Moderate Neck Disability Index (NDI) score
Able to give informed consent for study participation
Able and willing to return for all follow-up visits

Key Exclusion Criteria:

Significant cervical degenerative disc disease
Prior fusion procedure at any level(s) (C1-T1)
Marked cervical instability on lateral or flexion/extension radiographs
Presence of systemic infection or infection at the surgical site
Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
History of alcohol and/or drug abuse
Any known allergy to a metal alloy or polyethylene
Morbid obesity
Any significant general illness (e.g., metastatic cancer, HIV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432159

Show 32 Study Locations

Sponsors and Collaborators

DePuy Spine

More Information

No publications provided

Responsible Party:	Christopher Fang, DePuy Spine
ClinicalTrials.gov Identifier:	NCT00432159 History of Changes
Other Study ID Numbers:	06-DISCOVER
Study First Received:	February 5, 2007
Last Updated:	February 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by DePuy Spine:

cervical
spinal
arthroplasty

disc
surgical
ACDF

Additional relevant MeSH terms:

Spinal Diseases
Intervertebral Disk Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012