Trial record 14 of 63 for:    Open Studies | "Bone Transplantation"

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02030899
First received: January 2, 2014
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Cervical Vertebrae
Single
Degenerative Disease
Procedure: Cage fusion
Procedure: Plate fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Fusion rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The rate of interbody fusion at 2 years


Secondary Outcome Measures:
  • Segmental angle [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • cervical lordosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • pain change [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • functional status change. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cage
Cage filled with autologous bone
Procedure: Cage fusion
Randomized selection of surgery type
Other Name: Use of stand-alone Cage filled with autologous bone
Plate
Plate augmentation after iliac bone graft
Procedure: Plate fusion
Randomized selection of surgery type
Other Name: Use of Plate augmentation after autologous iliac bone graft

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030899

Contacts
Contact: Chi Heon Kim, Associated Professor +82-2-2072-3398 chiheon1@snu.ac.kr
Contact: Chun Kee Chung, Professor +82-2-2072-2352 chungc@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chi Heon Kim, MD, PhD    +82-2-2072-2358    chiheon1@snu.ac.kr   
Principal Investigator: Chun Kee Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02030899     History of Changes
Other Study ID Numbers: CAP_2014
Study First Received: January 2, 2014
Last Updated: January 7, 2014
Health Authority: Seoul National University Hospital, Seoul: Republic of Korea

Keywords provided by Seoul National University Hospital:
Cervical vertebrae
single
degenerative disease
Fusion
Sagittal angle

ClinicalTrials.gov processed this record on September 18, 2014