- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215293
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cervical Cage
Cervical I/F Cage
|
|
Active Comparator: Graft Spacer
Autograft or allograft with a plate, or autograft alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neck Disability Index
|
|
Fusion Status
Time Frame: 24 months
|
24 months
|
Neurological Status
|
|
Secondary Surgical Interventions
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse Events
|
Disc Space Height
|
Donor Site Pain
|
Neck Pain
|
Arm Pain
|
Sagittal Alignment
|
SF-36, Health Related Quality of Life
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G000019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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