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 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.

Study Overview

• Status: Completed
• Conditions: Cervical Degenerative Disc Disease
• Intervention / Treatment: Device: Cervical TDR; Device: ACDF 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 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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 disc; cervical arthroplasty; 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 disc; cervical arthroplasty; 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 disc; cervical arthroplasty; c-TDR; DISCOVER disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Success	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NDI Success	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.	24 months
Neurological Component of Success	no new clinically significant permanent abnormalities in neurological function	24 months
Subsequent Secondary Surgery Component of Success	no subsequent secondary surgical intervention at the index level	24 months
Device-Related SAE Component of Success	no device related serious adverse events	24 months
NDI - Change From Baseline	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.	24 months
Neck Pain VAS Scores - Change From Baseline	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.	24 months
Maximum Arm Pain VAS - Change From Baseline	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.	24 months
Average Arm Pain VAS - Change From Baseline	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.	24 months
Maximum Shoulder Pain VAS - Change From Baseline	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.	24 months
Average Shoulder Pain VAS - Change From Baseline	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.	24 months
Dysphagia Disability Index - Change From Baseline	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.	24 months
SF-36 - Physical Composite Scores (PCS) - Change From Baseline	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)	24 months
SF-36 - Mental Composite Scores (MCS) - Change From Baseline	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)	24 months
Work Status Assessment		24 months
Return to Work	Estimated Proportion of Subjects Returning to Work	24 months
Activity	Clinical Assessment of Activity	24 months
Subject Satisfaction	Subject Satisfaction (Would you have this procedure again?)	24 months
Global Cervical Range of Motion - Change From Baseline		24 months
Average Radiographic Disc Height (mm) - Change From Post-op		24 months

Collaborators and Investigators

• Sponsor: DePuy Spine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2006
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 5, 2007
• First Submitted That Met QC Criteria: February 5, 2007
• First Posted (Estimate): February 7, 2007

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: DDD; arthroplasty; surgical; ACDF; spinal; cervical; disc
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 06-DISCOVER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes