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

Purpose

This study is intended to evaluate if for patients with symptomatic degenerative disc disease at one or two adjacent levels of the cervical spine, will total disc replacement with the DISCOVER Artificial Cervical Disc compared to cervical fusion be safe and effective at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

Condition	Intervention
Cervical Degenerative Disc Disease	Device: Cervical TDR Device: ACDF with plate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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:

Overall Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.

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:	500
Study Start Date:	July 2006
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.	Device: Cervical TDR Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Other Names: cervical arthroplasty cervical disc c-TDR DISCOVER disc
Active Comparator: 1-level ACDF with plate Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.	Device: ACDF with plate Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Other Names: ACDF Slim-Loc Anterior cervical discectomy and fusion with plate
Experimental: 2-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.	Device: Cervical TDR Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Other Names: cervical arthroplasty cervical disc c-TDR DISCOVER disc
Active Comparator: 2-level ACDF Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.	Device: ACDF with plate Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Other Names: ACDF Slim-Loc Anterior cervical discectomy and fusion with plate

Detailed Description:

This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and 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, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participating at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

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:	DePuy Spine
ClinicalTrials.gov Identifier:	NCT00432159 History of Changes
Other Study ID Numbers:	06-DISCOVER
Study First Received:	February 5, 2007
Last Updated:	February 19, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by DePuy Spine:

cervical
spinal
arthroplasty
disc

surgical
ACDF
DDD

Additional relevant MeSH terms:

Spinal Diseases
Intervertebral Disk Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013