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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
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
Secondary ID [1] 0 0
06-DISCOVER
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Degenerative Disc Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Neurological Component of Success - no new clinically significant permanent abnormalities in neurological function
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Subsequent Secondary Surgery Component of Success - no subsequent secondary surgical intervention at the index level
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Device-Related SAE Component of Success - no device related serious adverse events
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Work Status Assessment
Timepoint [14] 0 0
24 months
Secondary outcome [15] 0 0
Return to Work - Estimated Proportion of Subjects Returning to Work
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Activity - Clinical Assessment of Activity
Timepoint [16] 0 0
24 months
Secondary outcome [17] 0 0
Subject Satisfaction - Subject Satisfaction (Would you have this procedure again?)
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Global Cervical Range of Motion - Change From Baseline
Timepoint [18] 0 0
24 months
Secondary outcome [19] 0 0
Average Radiographic Disc Height (mm) - Change From Post-op
Timepoint [19] 0 0
24 months

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
Minimum age
21 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pacific Private Clinic - Queensland
Recruitment postcode(s) [1] 0 0
4215 - Queensland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Netherlands
State/province [24] 0 0
Tilburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy Spine
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00432159
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications