A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo

Study Overview
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Brief Summary
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The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.

Detailed Description
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This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degenerative disc disease (DDD). 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other group will be treated with ACDF. The clinical outcomes and radiographic measurements will be compared between two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Official Title
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Clinical and Radiographic Analysis of ProDisc-C Vivo to Treat Degenerative Disc Disease: A 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Clinical Trial.

Conditions
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Disk Degeneration, Cervical Disc Disease

Intervention / Treatment
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* Procedure: ProDisc-C vivo
* Procedure: Anterior cervical discectomy fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single-level cervical disc disease. At least one additional confirmatory neuroradiographic study, such as MRI or CT- enhanced myelography that showed findings consistent with clinical findings and complaints. Exclusion Criteria: Patients have cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability. Symptomatic disc disease at level C2 -3 or C7-T1. A history of discitis. A medical condition that required medication,such as steroids or nonsteroidal antiinflammatory medications that could interfere with fusion.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other groups will be treated with ACDF.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProDisc-C vivo<br>This group of patients will be treated with ProDisc-C vivo disc replacement (single segment). | Procedure: ProDisc-C vivo<br>* Total Disc Replacement using ProDisc-C vivo.<br>|
| Active Comparator: Anterior cervical discectomy fusion<br>This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment). | Procedure: Anterior cervical discectomy fusion<br>* Anterior Cervical Discectomy and Fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of overall success rate | A patient's outcome was considered an overall success if all of the following conditions were met: 1) postoperative (Neck Disability Index) NDI score improvement of at least a 15-point increase from preoperative score; 2) maintenance or improvement in neurological status; 3) disc height success; 4) no serious adverse event classified as implant associated or implant/surgical procedure associated; and 5) no additional surgical procedure classified as a failure. | The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sagittal angular motion | Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured. | The radiographic outcomes will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments). | 
| Change of neck disability index scores | The neck disability index(NDI) questionnaire measures the level of pain and disability associated with various activities. The NDI is a 10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. Each item is scored 0 to 5. The NDI score is a sum of the scores of the10-item. Clinical effects will be evaluated based on scores of the NDI. Higher values represent a better outcome. | The NDI scores will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments). | 
| Change of Arm and Neck pain intensity | Neck and arm pain scores will be measured using a visual analogue scale (VAS) from 0' (no sensation) to '100(the most intense pain imaginable) where 30 means pain threshold. | Neck and arm pain scores will be measured at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProDisc-C vivo, ACDF, Cervical degenerative disc disease