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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)
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
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
NDI Success
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Neurological Component of Success
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Subsequent Secondary Surgery Component of Success
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Device-Related SAE Component of Success
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
NDI - Change From Baseline
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Neck Pain VAS Scores - Change From Baseline
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Maximum Arm Pain VAS - Change From Baseline
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Average Arm Pain VAS - Change From Baseline
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Maximum Shoulder Pain VAS - Change From Baseline
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Average Shoulder Pain VAS - Change From Baseline
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Dysphagia Disability Index - Change From Baseline
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
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
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Activity
Timepoint [16] 0 0
24 months
Secondary outcome [17] 0 0
Subject Satisfaction
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
Sex
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
NA
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
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
500
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
Trial website
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

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