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Cervical I/F Cage for Anterior Cervical Fusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215293
First Posted: September 22, 2005
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy Spine
  Purpose
The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate

Condition Intervention Phase
Cervical Intervertebral Disc Degeneration Device: Cervical I/F Cage Device: Autograft or allograft with a plate, or autograft alone. Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion

Resource links provided by NLM:


Further study details as provided by DePuy Spine:

Primary Outcome Measures:
  • Fusion Status [ Time Frame: 24 months ]
  • Neck Disability Index
  • Neurological Status
  • Secondary Surgical Interventions

Secondary Outcome Measures:
  • Adverse Events
  • Donor Site Pain
  • Neck Pain
  • Arm Pain
  • Disc Space Height
  • Sagittal Alignment
  • SF-36, Health Related Quality of Life

Enrollment: 240
Study Start Date: August 2000
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical Cage
Cervical I/F Cage
Device: Cervical I/F Cage
Active Comparator: Graft Spacer
Autograft or allograft with a plate, or autograft alone.
Device: Autograft or allograft with a plate, or autograft alone.

Detailed Description:

This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between the investigational and control groups.

Comparison: The device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). For two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. Based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. However, amongst the investigators there are preferred treatments. Each investigator will choose one or more of the control treatments at study initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
  • Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)

Exclusion Criteria:

  • Significant degeneration at more than two cervical levels,
  • Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
  • Gross instability due to trauma,
  • Disability in the lumbar spine,
  • Infection in the disc or spine, past or present,
  • Any active infection at time of surgery,
  • Tumor in the spine,
  • Significant osteoporosis or metabolic bone disease,
  • Pregnant, lactating or wishes to become pregnant within duration of the study,
  • Refusal to accept the use of autograft tissue.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT00215293     History of Changes
Other Study ID Numbers: G000019
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by DePuy Spine:
fusion
cervical
spine

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases