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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00432159
Registration number
NCT00432159
Ethics application status
Date submitted
5/02/2007
Date registered
7/02/2007
Date last updated
20/10/2017
Titles & IDs
Public title
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
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Scientific 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
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Secondary ID [1]
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06-DISCOVER
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Degenerative Disc Disease
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Cervical TDR
Treatment: Devices - ACDF 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.
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.
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.
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.
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.
Treatment: Devices: Cervical TDR
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Treatment: Devices: ACDF with plate
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Success
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Assessment method [1]
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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.
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Timepoint [1]
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24 months
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Secondary outcome [1]
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NDI Success
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Assessment method [1]
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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.
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Neurological Component of Success
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Assessment method [2]
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no new clinically significant permanent abnormalities in neurological function
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Subsequent Secondary Surgery Component of Success
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Assessment method [3]
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no subsequent secondary surgical intervention at the index level
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Device-Related SAE Component of Success
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Assessment method [4]
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no device related serious adverse events
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Timepoint [4]
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24 months
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Secondary outcome [5]
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NDI - Change From Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Neck Pain VAS Scores - Change From Baseline
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Assessment method [6]
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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.
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Timepoint [6]
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24 months
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Secondary outcome [7]
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Maximum Arm Pain VAS - Change From Baseline
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Assessment method [7]
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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.
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Average Arm Pain VAS - Change From Baseline
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Assessment method [8]
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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.
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Maximum Shoulder Pain VAS - Change From Baseline
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Assessment method [9]
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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.
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Timepoint [9]
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24 months
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Secondary outcome [10]
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Average Shoulder Pain VAS - Change From Baseline
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Assessment method [10]
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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.
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Timepoint [10]
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24 months
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Secondary outcome [11]
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Dysphagia Disability Index - Change From Baseline
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Assessment method [11]
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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.
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Timepoint [11]
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24 months
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Secondary outcome [12]
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SF-36 - Physical Composite Scores (PCS) - Change From Baseline
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Assessment method [12]
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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)
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Timepoint [12]
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24 months
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Secondary outcome [13]
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SF-36 - Mental Composite Scores (MCS) - Change From Baseline
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Assessment method [13]
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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)
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Timepoint [13]
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24 months
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Secondary outcome [14]
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Work Status Assessment
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Assessment method [14]
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Timepoint [14]
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24 months
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Secondary outcome [15]
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Return to Work
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Assessment method [15]
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Estimated Proportion of Subjects Returning to Work
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Timepoint [15]
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24 months
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Secondary outcome [16]
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Activity
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Assessment method [16]
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Clinical Assessment of Activity
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Timepoint [16]
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24 months
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Secondary outcome [17]
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Subject Satisfaction
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Assessment method [17]
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Subject Satisfaction (Would you have this procedure again?)
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Timepoint [17]
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24 months
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Secondary outcome [18]
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Global Cervical Range of Motion - Change From Baseline
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Assessment method [18]
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Timepoint [18]
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24 months
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Secondary outcome [19]
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Average Radiographic Disc Height (mm) - Change From Post-op
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Assessment method [19]
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Timepoint [19]
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24 months
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
21
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2016
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Sample size
Target
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Accrual to date
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Final
500
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Pacific Private Clinic - Queensland
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Recruitment postcode(s) [1]
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4215 - Queensland
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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Country [5]
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United States of America
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State/province [5]
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Georgia
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Country [6]
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United States of America
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State/province [6]
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Illinois
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Country [7]
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United States of America
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Kansas
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Country [8]
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United States of America
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State/province [8]
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Kentucky
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Maryland
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Country [10]
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United States of America
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State/province [10]
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Massachusetts
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Country [11]
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United States of America
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State/province [11]
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Michigan
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Minnesota
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Missouri
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Montana
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Country [15]
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Nebraska
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Nevada
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New Jersey
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Country [18]
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United States of America
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State/province [18]
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New York
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Country [19]
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State/province [19]
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North Carolina
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Country [20]
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Oregon
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Texas
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Utah
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Country [23]
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United States of America
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State/province [23]
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Virginia
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Country [24]
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Netherlands
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State/province [24]
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Tilburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
DePuy Spine
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00432159
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00432159
Download to PDF