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OpenTrials
Completed

NCT Number: NCT02030899

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

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

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Key information

Conditions

Cervical Vertebrae Degenerative Disease Single

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

cage: MC+® cage plate: atlantis® plate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cage fusion

Procedure

Randomized selection of surgery type

Other names: Use of stand-alone Cage filled with autologous bone

Plate fusion

Procedure

Randomized selection of surgery type

Other names: Use of Plate augmentation after autologous iliac bone graft

Primary outcomes

  1. Fusion rate

    Time frame: 2 years

    The rate of interbody fusion at 2 years

Secondary outcomes

  1. Segmental angle

    Time frame: 2 years

    the segmental angle at the fused level

  2. cervical lordosis

    Time frame: 2 years

    The cervical lordosis at 2 years

  3. pain change

    Time frame: 2 years

    Visual analogue pain score

  4. functional status change.

    Time frame: 2 years

    Neck disability index

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: CAP_2014

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2014
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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