Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03367039
Study type Interventional
Source Peking University People's Hospital
Contact Weiwei Xia, Ph.D.
Phone 008613260001978
Email weiweixia2016@163.com
Status Not yet recruiting
Phase N/A
Start date March 1, 2018
Completion date March 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT04597112 - Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy N/A
Recruiting NCT06102681 - Examination of the Effect of Early Mobilization on Postoperative Recovery, Pain, Quality of Life and Complication Development in Elective Minimally Invasive Spine Surgery N/A
Not yet recruiting NCT04627454 - Dynamic Cervical Implant in Treatment of Cervical Disc Disease N/A
Completed NCT03077516 - Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
Active, not recruiting NCT04547959 - Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA® N/A
Enrolling by invitation NCT05066711 - NuVasive® ACP System Study
Active, not recruiting NCT03036007 - Physiotherapy After Anterior Cervical Spine Surgery N/A
Terminated NCT01433367 - A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease N/A
Enrolling by invitation NCT04770571 - Posterior Cervical Fixation Study
Active, not recruiting NCT04564885 - A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels N/A
Active, not recruiting NCT04520776 - A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease N/A
Terminated NCT00945243 - Clinical Outcomes Study Evaluating the Zero-P PEEK N/A
Enrolling by invitation NCT05691231 - Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Recruiting NCT04623593 - Cervical Arthroplasty Cost Effectiveness Study (CACES) N/A
Withdrawn NCT04239638 - Analysis of Cervical Spinal MRI With Deep Learning
Terminated NCT03786432 - Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery N/A
Completed NCT05262478 - Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis
Completed NCT04734977 - Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: N/A
Not yet recruiting NCT03541681 - Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy N/A
Not yet recruiting NCT03367052 - Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct. N/A