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
Cervical Intervertebral Disc Degeneration
Device: Cervical I/F Cage
Device: Autograft or allograft with a plate, or autograft alone.
|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|
- 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 ]
- 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 ]
|Study Start Date:||August 2000|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.|
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.