Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
Query!
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
Query!
Secondary ID [1]
0
0
06-DISCOVER
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cervical Degenerative Disc Disease
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Success
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
24 months
Query!
Secondary outcome [1]
0
0
NDI Success
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
24 months
Query!
Secondary outcome [2]
0
0
Neurological Component of Success
Query!
Assessment method [2]
0
0
no new clinically significant permanent abnormalities in neurological function
Query!
Timepoint [2]
0
0
24 months
Query!
Secondary outcome [3]
0
0
Subsequent Secondary Surgery Component of Success
Query!
Assessment method [3]
0
0
no subsequent secondary surgical intervention at the index level
Query!
Timepoint [3]
0
0
24 months
Query!
Secondary outcome [4]
0
0
Device-Related SAE Component of Success
Query!
Assessment method [4]
0
0
no device related serious adverse events
Query!
Timepoint [4]
0
0
24 months
Query!
Secondary outcome [5]
0
0
NDI - Change From Baseline
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
24 months
Query!
Secondary outcome [6]
0
0
Neck Pain VAS Scores - Change From Baseline
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
24 months
Query!
Secondary outcome [7]
0
0
Maximum Arm Pain VAS - Change From Baseline
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
24 months
Query!
Secondary outcome [8]
0
0
Average Arm Pain VAS - Change From Baseline
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
24 months
Query!
Secondary outcome [9]
0
0
Maximum Shoulder Pain VAS - Change From Baseline
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
24 months
Query!
Secondary outcome [10]
0
0
Average Shoulder Pain VAS - Change From Baseline
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
24 months
Query!
Secondary outcome [11]
0
0
Dysphagia Disability Index - Change From Baseline
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
24 months
Query!
Secondary outcome [12]
0
0
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Query!
Assessment method [12]
0
0
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)
Query!
Timepoint [12]
0
0
24 months
Query!
Secondary outcome [13]
0
0
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Query!
Assessment method [13]
0
0
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)
Query!
Timepoint [13]
0
0
24 months
Query!
Secondary outcome [14]
0
0
Work Status Assessment
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
24 months
Query!
Secondary outcome [15]
0
0
Return to Work
Query!
Assessment method [15]
0
0
Estimated Proportion of Subjects Returning to Work
Query!
Timepoint [15]
0
0
24 months
Query!
Secondary outcome [16]
0
0
Activity
Query!
Assessment method [16]
0
0
Clinical Assessment of Activity
Query!
Timepoint [16]
0
0
24 months
Query!
Secondary outcome [17]
0
0
Subject Satisfaction
Query!
Assessment method [17]
0
0
Subject Satisfaction (Would you have this procedure again?)
Query!
Timepoint [17]
0
0
24 months
Query!
Secondary outcome [18]
0
0
Global Cervical Range of Motion - Change From Baseline
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
24 months
Query!
Secondary outcome [19]
0
0
Average Radiographic Disc Height (mm) - Change From Post-op
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
24 months
Query!
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
Key
Query!
Minimum age
21
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
500
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Pacific Private Clinic - Queensland
Query!
Recruitment postcode(s) [1]
0
0
4215 - Queensland
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Montana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
Netherlands
Query!
State/province [24]
0
0
Tilburg
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
DePuy Spine
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00432159
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00432159
Download to PDF