N/A
N=500
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Cervical Degenerative Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT00432159 ↗Enrolled (actual)
500
Serious AEs
29.2%
Results posted
Aug 2014
Primary outcome: Primary: Overall Success — 137; 110; 28; 13 participants who are successes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cervical TDR (Device); ACDF with plate (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- DePuy Spine
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Success |
137; 110; 28; 13; 65 | — |
| SECONDARY NDI Success |
139; 111; 29; 13; 67 | — |
| SECONDARY Neurological Component of Success |
161; 127; 35; 15; 77 | — |
| SECONDARY Subsequent Secondary Surgery Component of Success |
176; 160; 35; 18; 84 | — |
| SECONDARY Device-Related SAE Component of Success |
184; 167; 39; 20; 89 | — |
| SECONDARY NDI - Change From Baseline |
-33.4; -33.2; -32.8; -32.9; -34.3 | — |
| SECONDARY Neck Pain VAS Scores - Change From Baseline |
-47.0; -41.5; -36.1; -27.2; -46.3 | — |
| SECONDARY Maximum Arm Pain VAS - Change From Baseline |
-52.0; -49.5; -42.4; -30.9; -44.3 | — |
| SECONDARY Average Arm Pain VAS - Change From Baseline |
-32.1; -28.8; -30.5; -20.6; -26.6 | — |
| SECONDARY Maximum Shoulder Pain VAS - Change From Baseline |
-52.1; -47.9; -43.0; -21.4; -45.9 | — |
| SECONDARY Average Shoulder Pain VAS - Change From Baseline |
-34.1; -31.6; -31.7; -15.6; -31.0 | — |
| SECONDARY Dysphagia Disability Index - Change From Baseline |
-1.3; 0.7; 0.3; 1.2; -0.8 | — |
| SECONDARY SF-36 - Physical Composite Scores (PCS) - Change From Baseline |
14.2; 13.3; 15.2; 6.6; 15.2 | — |
| SECONDARY SF-36 - Mental Composite Scores (MCS) - Change From Baseline |
9.2; 8.8; 6.3; 12.2; 6.3 | — |
| SECONDARY Work Status Assessment |
28; 18; 6; 2; 11; 111 | — |
| SECONDARY Return to Work |
87; 86; 84; 90; 92 | — |
| SECONDARY Activity |
39; 30; 11; 5; 21; 79 | — |
| SECONDARY Subject Satisfaction |
121; 86; 24; 8; 62; 25 | — |
| SECONDARY Global Cervical Range of Motion - Change From Baseline |
5.4; -2.8; 3.0; -14.4; 2.1 | — |
| SECONDARY Average Radiographic Disc Height (mm) - Change From Post-op |
-1.0; -1.0 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00432159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.