Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
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| ClinicalTrials.gov Identifier: NCT00432159 |
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Recruitment Status :
Completed
First Posted : February 7, 2007
Results First Posted : August 7, 2014
Last Update Posted : October 20, 2017
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Sponsor:
DePuy Spine
Information provided by (Responsible Party):
DePuy Spine
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Degenerative Disc Disease | Device: Cervical TDR Device: ACDF with plate | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Masking Description: | Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked. |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | July 1, 2006 |
| Actual Primary Completion Date : | May 1, 2013 |
| Actual Study Completion Date : | May 1, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Intervertebral disc disease
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Cervical TDR
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Other Names:
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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.
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Device: ACDF with plate
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Other Names:
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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.
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Device: Cervical TDR
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Other Names:
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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.
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Device: ACDF with plate
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Other Names:
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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.
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Device: Cervical TDR
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Other Names:
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Primary Outcome Measures :
- Overall Success [ Time Frame: 24 months ]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.
Secondary Outcome Measures :
- NDI Success [ Time Frame: 24 months ]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.
- Neurological Component of Success [ Time Frame: 24 months ]no new clinically significant permanent abnormalities in neurological function
- Subsequent Secondary Surgery Component of Success [ Time Frame: 24 months ]no subsequent secondary surgical intervention at the index level
- Device-Related SAE Component of Success [ Time Frame: 24 months ]no device related serious adverse events
- NDI - Change From Baseline [ Time Frame: 24 months ]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.
- Neck Pain VAS Scores - Change From Baseline [ Time Frame: 24 months ]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.
- Maximum Arm Pain VAS - Change From Baseline [ Time Frame: 24 months ]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.
- Average Arm Pain VAS - Change From Baseline [ Time Frame: 24 months ]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.
- Maximum Shoulder Pain VAS - Change From Baseline [ Time Frame: 24 months ]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.
- Average Shoulder Pain VAS - Change From Baseline [ Time Frame: 24 months ]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.
- Dysphagia Disability Index - Change From Baseline [ Time Frame: 24 months ]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.
- SF-36 - Physical Composite Scores (PCS) - Change From Baseline [ Time Frame: 24 months ]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)
- SF-36 - Mental Composite Scores (MCS) - Change From Baseline [ Time Frame: 24 months ]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)
- Work Status Assessment [ Time Frame: 24 months ]
- Return to Work [ Time Frame: 24 months ]Estimated Proportion of Subjects Returning to Work
- Activity [ Time Frame: 24 months ]Clinical Assessment of Activity
- Subject Satisfaction [ Time Frame: 24 months ]Subject Satisfaction (Would you have this procedure again?)
- Global Cervical Range of Motion - Change From Baseline [ Time Frame: 24 months ]
- Average Radiographic Disc Height (mm) - Change From Post-op [ Time Frame: 24 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432159
Locations
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Sponsors and Collaborators
DePuy Spine
| Responsible Party: | DePuy Spine |
| ClinicalTrials.gov Identifier: | NCT00432159 |
| Other Study ID Numbers: |
06-DISCOVER |
| First Posted: | February 7, 2007 Key Record Dates |
| Results First Posted: | August 7, 2014 |
| Last Update Posted: | October 20, 2017 |
| Last Verified: | September 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by DePuy Spine:
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cervical spinal arthroplasty disc |
surgical ACDF DDD |
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases |