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: February 19, 2013
Last verified: February 2013

February 5, 2007
February 19, 2013
July 2006
May 2013   (final data collection date for primary outcome measure)
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.
  • Neck Disability Index
  • Significant permanent abnormalities in neurological function
  • Subsequent secondary surgical interventions at the index level(s)
  • Device-related serious adverse events
Complete list of historical versions of study NCT00432159 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Disc height
  • Foraminal height
  • Global Cervical range of motion
  • Sagittal angulation
  • Adjacent level degeneration and/or disease
  • Pain measured by Visual Analogue Scale
  • Quality of Life by SF-36
  • Dysphagia Disability Index
  • Patient Satisfaction
  • Work Status Assessment
Not Provided
Not Provided
 
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Degenerative Disc Disease
  • Device: Cervical TDR
    Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
    Other Names:
    • cervical arthroplasty
    • cervical disc
    • c-TDR
    • DISCOVER disc
  • 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: 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.
    Intervention: Device: Cervical TDR
  • 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.
    Intervention: Device: ACDF 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.
    Intervention: Device: Cervical TDR
  • 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.
    Intervention: Device: ACDF with plate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
May 2016
May 2013   (final data collection date for primary outcome measure)

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)
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Netherlands
 
NCT00432159
06-DISCOVER
Yes
DePuy Spine
DePuy Spine
Not Provided
Not Provided
DePuy Spine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP