NCT03367052

Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.

Clinical and Radiological Outcomes of a 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Trial: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 542 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.

Detailed description

This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterior cervical discectomy fusion) and ProDisc-C vivo to treat degenerative disc disease (DDD). 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be done at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Conditions

• Cervical Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Two level Prodisc-C vivo	Two level of Prodisc-C vivo artificial disc replacement will be done in one group of patients.
PROCEDURE	Hybrid	The hybrid method will be used in one group of patients.

Timeline

• Start date: 2018-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2017-12-08
• Last updated: 2017-12-08