A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion

Seoul National University

Status: Active, not recruiting

Conditions: Myelopathy; Radiculopathy, Cervical

Treatments: Device: Cage and Plate; Procedure: anterior cervical discectomy and fusion; Device: Cage alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01911013

KSSS-001

Details and patient eligibility

About

The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.

Enrollment: 500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• degenerative cervical disease
• radiculopathy or myelopathy refractory to conservative treatment
• be scheduled to undergo one segment anterior cervical discectomy and fusion
• age is more than 19 years old
• all requirements of preoperative image studies are satisfied

Exclusion criteria

• previous neck surgery or radiation treatments at neck area
• fusion at adjacent segments
• two segment fusion is expected
• C2-3 or C7-T1
• high risk for additional cervical surgery within one year
• ossification of posterior longitudinal ligaments, trauma, infection, tumor, congenital or developmental disease
• inadequate radiological images
• patient is not expected to be observed at long term follow-up (foreigner, international student)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Cage and Plate

Active Comparator group

Description:

anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system

Treatment:

Device: Cage and Plate

Procedure: anterior cervical discectomy and fusion

Cage alone

Experimental group

Description:

anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate

Treatment:

Procedure: anterior cervical discectomy and fusion

Device: Cage alone