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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT00215293     History of Changes
Other Study ID Numbers: G000019
Study First Received: September 13, 2005
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Spine:
fusion
cervical
spine

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

ClinicalTrials.gov processed this record on October 20, 2014