A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo
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|ClinicalTrials.gov Identifier: NCT03367039|
Recruitment Status : Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Disk Degeneration Cervical Disc Disease||Procedure: ProDisc-C vivo Procedure: Anterior cervical discectomy fusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||648 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||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.|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 1, 2025|
|Estimated Study Completion Date :||March 1, 2025|
Experimental: ProDisc-C vivo
This group of patients will be treated with ProDisc-C vivo disc replacement (single segment).
Procedure: ProDisc-C vivo
Total Disc Replacement using ProDisc-C vivo.
Active Comparator: Anterior cervical discectomy fusion
This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).
Procedure: Anterior cervical discectomy fusion
Anterior Cervical Discectomy and Fusion
- Change of overall success rate [ Time Frame: 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). ]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".
- Change of sagittal angular motion [ Time Frame: 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). ]Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured.
- Change of neck disability index scores [ Time Frame: 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). ]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.
- Change of Arm and Neck pain intensity [ Time Frame: 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). ]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".
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367039
|Contact: Weiwei Xia, Ph.D.||email@example.com|
|Contact: Zhenqi Zhu, Masterfirstname.lastname@example.org|
|Principal Investigator:||Zhenqi Zhu, Master||Peking University People's Hospital|