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

Degenerative Disease Clinical Trial

— CAP_2014  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030899
• Other study ID #: CAP_2014
• Status: Completed
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

cage: MC+® cage plate: atlantis® plate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Vertebrae
• Degenerative Disease
• Single

Intervention

Procedure:
• Cage fusion
Randomized selection of surgery type
• Plate fusion
Randomized selection of surgery type

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion rate	The rate of interbody fusion at 2 years	2 years
Secondary	Segmental angle	the segmental angle at the fused level	2 years
Secondary	cervical lordosis	The cervical lordosis at 2 years	2 years
Secondary	pain change	Visual analogue pain score	2 years
Secondary	functional status change.	Neck disability index	2 years