The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine (CAP_2014)

Seoul National University

Status: Completed

Conditions: Degenerative Disease; Cervical Vertebrae; Single

Treatments: Procedure: Plate fusion; Procedure: Cage fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02030899

CAP_2014

Details and patient eligibility

About

The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.

Full description

cage: MC+® cage plate: atlantis® plate

Enrollment: 90 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single level degenerative cervical spine disease
• aged 30 - 70
• no improvement of symptom for 8 weeks of non-surgical treatment.
• degeneration in other levels without stenosis, accepted

Exclusion criteria

• osteoporosis
• disease with poor bone quality
• Cancer
• Previous cervical spine surgery
• Multiple levels disease
• Ossification of posterior longitudinal ligament
• Kyphosis at the index level
• Developmental stenosis (diameter of C7 spinal canal < 10mm)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Cage

Active Comparator group

Description:

Cage filled with autologous bone

Treatment:

Procedure: Cage fusion

Plate

Other group

Description:

Plate augmentation after iliac bone graft

Treatment:

Procedure: Plate fusion