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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00432159
First received: February 5, 2007
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy 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

Resource links provided by NLM:


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:
  • NDI Success [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.

  • Neurological Component of Success [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    no new clinically significant permanent abnormalities in neurological function

  • Subsequent Secondary Surgery Component of Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    no subsequent secondary surgical intervention at the index level

  • Device-Related SAE Component of Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    no device related serious adverse events

  • NDI - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.

  • Neck Pain VAS Scores - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.

  • Maximum Arm Pain VAS - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.

  • Average Arm Pain VAS - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.

  • Maximum Shoulder Pain VAS - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.

  • Average Shoulder Pain VAS - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.

  • Dysphagia Disability Index - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.

  • SF-36 - Physical Composite Scores (PCS) - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)

  • SF-36 - Mental Composite Scores (MCS) - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)

  • Work Status Assessment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Return to Work [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Estimated Proportion of Subjects Returning to Work

  • Activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Clinical Assessment of Activity

  • Subject Satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Subject Satisfaction (Would you have this procedure again?)

  • Global Cervical Range of Motion - Change From Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Average Radiographic Disc Height (mm) - Change From Post-op [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: July 2006
Estimated Study Completion Date: May 2016
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
Experimental: Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Device: Cervical TDR
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Other Names:
  • cervical arthroplasty
  • cervical disc
  • c-TDR
  • DISCOVER disc

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 participation 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Olympia Medical Center
Beverly Hills, California, United States, 90211
Sutter Medical Center
Sacramento, California, United States, 95816
United States, Colorado
Rocky Mountain Associates in Orthopedic Medicine, PC
Loveland, Colorado, United States, 80538
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Orthopaedic Institute
Tampa, Florida, United States, 33607
United States, Georgia
Emory Orthopaedics and Spine Center
Atlanta, Georgia, United States, 30329
United States, Illinois
Rush University/Midwest Orthopaedics
Chicago, Illinois, United States, 60607
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
United States, Kansas
Johnson County Spine
Overland Park, Kansas, United States, 66210
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21210
United States, Massachusetts
Boston Spine Group
Newton, Massachusetts, United States, 02458
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Twin Cities Spine
Minneapolis, Minnesota, United States, 55404
United States, Missouri
St. John's Regional Medical Center
Springfield, Missouri, United States, 65804
United States, Montana
St. Patrick Hospital Neurological Associates
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Spine Center, LLC
Omaha, Nebraska, United States, 68154
United States, Nevada
Center for Diseases and Surgery of the Spine
Las Vegas, Nevada, United States, 89106
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07101
United States, New York
Southern NY Neurosurgical Group
Johnson City, New York, United States, 13790
Upstate Medical College/SUNY
Syracuse, New York, United States, 13202
United States, North Carolina
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States, 28204
Triangle Orthopaedic Associates
Durham, North Carolina, United States, 27704
United States, Oregon
Neurospine Institute
Eugene, Oregon, United States, 97401
United States, Texas
North Texas Spine Care at Baylor Health
Dallas, Texas, United States, 75246
Texas Back Institute
Plano, Texas, United States, 75093
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Australia
Pacific Private Clinic
Queensland, Australia, 4215
Netherlands
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
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
Results First Received: May 27, 2014
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Spine:
cervical
spinal
arthroplasty
disc
surgical
ACDF
DDD

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014