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Cervical I/F Cage for Anterior Cervical Fusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00215293
First received: September 13, 2005
Last updated: May 22, 2014
Last verified: May 2014

September 13, 2005
May 22, 2014
August 2000
October 2007   (final data collection date for primary outcome measure)
  • Fusion Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Neck Disability Index [ Designated as safety issue: No ]
  • Neurological Status [ Designated as safety issue: Yes ]
  • Secondary Surgical Interventions [ Designated as safety issue: Yes ]
  • Fusion Status
  • Neck Disability Index
  • Neurological Status
  • Secondary Surgical Interventions
Complete list of historical versions of study NCT00215293 on ClinicalTrials.gov Archive Site
  • Adverse Events [ Designated as safety issue: Yes ]
  • Donor Site Pain [ Designated as safety issue: No ]
  • Neck Pain [ Designated as safety issue: No ]
  • Arm Pain [ Designated as safety issue: No ]
  • Disc Space Height [ Designated as safety issue: No ]
  • Sagittal Alignment [ Designated as safety issue: No ]
  • SF-36, Health Related Quality of Life [ Designated as safety issue: No ]
  • Adverse Events
  • Donor Site Pain
  • Neck Pain
  • Arm Pain
  • Disc Space Height
  • Sagittal Alignment
  • SF-36, Health Related Quality of Life
Not Provided
Not Provided
 
Cervical I/F Cage for Anterior Cervical Fusion
A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Intervertebral Disc Degeneration
  • Device: Cervical I/F Cage
  • Device: Autograft or allograft with a plate, or autograft alone.
  • Experimental: Cervical Cage
    Cervical I/F Cage
    Intervention: Device: Cervical I/F Cage
  • Active Comparator: Graft Spacer
    Autograft or allograft with a plate, or autograft alone.
    Intervention: Device: Autograft or allograft with a plate, or autograft alone.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00215293
G000019
No
DePuy Spine
DePuy Spine
Not Provided
Not Provided
DePuy Spine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP