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

Peking University

Status: Not yet enrolling

Conditions: Cervical Disc Disease; Disk Degeneration

Treatments: Procedure: Anterior cervical discectomy fusion; Procedure: ProDisc-C vivo

Study type: Interventional

Funder types: Other

Identifiers

NCT03367039

Prodisc-C vivo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 648 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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648 participants in 2 patient groups

ProDisc-C vivo

Experimental group

Description:

This group of patients will be treated with ProDisc-C vivo disc replacement (single segment).

Treatment:

Procedure: ProDisc-C vivo

Anterior cervical discectomy fusion

Active Comparator group

Description:

This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).

Treatment:

Procedure: Anterior cervical discectomy fusion