NCT02030899

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

6.1 years

First QC Date

January 2, 2014

Last Update Submit

April 16, 2024

Conditions

Cervical VertebraeSingleDegenerative Disease

Keywords

Cervical vertebraesingledegenerative diseaseFusionSagittal angle

Outcome Measures

Primary Outcomes (1)

  • Fusion rate

    The rate of interbody fusion at 2 years

    2 years

Secondary Outcomes (4)

  • Segmental angle

    2 years

  • cervical lordosis

    2 years

  • pain change

    2 years

  • functional status change.

    2 years

Study Arms (2)

Cage

ACTIVE COMPARATOR

Cage filled with autologous bone

Procedure: Cage fusion

Plate

OTHER

Plate augmentation after iliac bone graft

Procedure: Plate fusion

Interventions

Cage fusionPROCEDURE

Randomized selection of surgery type

Also known as: Use of stand-alone Cage filled with autologous bone
Cage
Plate fusionPROCEDURE

Randomized selection of surgery type

Also known as: Use of Plate augmentation after autologous iliac bone graft
Plate

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: ACDF with plate and autologous bone
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 9, 2014

Study Start

December 1, 2013

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

KR(1)