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

Peking University

Status: Not yet enrolling

Conditions: Cervical Disc Disease

Treatments: Procedure: Two level Prodisc-C vivo; Procedure: Hybrid

Study type: Interventional

Funder types: Other

Identifiers

NCT03367052

twolevelprodiscC

Details and patient eligibility

About

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

Full 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.

Enrollment: 542 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-7.
• The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
• The patient demonstrates progressive symptoms calling for immediate surgery.

Exclusion criteria

• Any prior cervical spine surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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542 participants in 2 patient groups

Two level Prodisc-C vivo

Experimental group

Description:

Two level Prodisc-C vivo cervical artificial disc replacement.

Treatment:

Procedure: Two level Prodisc-C vivo

Hybrid

Active Comparator group

Description:

This group of patients will be treated with hybrid construct, i.e., one level of Prodisc-C vivo and one level of anterior cervical discectomy fusion (ACDF).

Treatment:

Procedure: Hybrid