Cervical I/F Cage for Anterior Cervical Fusion

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion

Conditions
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Cervical Intervertebral Disc Degeneration

Intervention / Treatment
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* Device: Cervical I/F Cage
* Device: Autograft or allograft with a plate, or autograft alone.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical Cage<br>Cervical I/F Cage | Device: Cervical I/F Cage<br> <br> |
| Active Comparator: Graft Spacer<br>Autograft or allograft with a plate, or autograft alone. | Device: Autograft or allograft with a plate, or autograft alone.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Status |  | 24 months | 
| Neck Disability Index |  |  | 
| Neurological Status |  |  | 
| Secondary Surgical Interventions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  |  | 
| Donor Site Pain |  |  | 
| Neck Pain |  |  | 
| Arm Pain |  |  | 
| Disc Space Height |  |  | 
| Sagittal Alignment |  |  | 
| SF-36, Health Related Quality of Life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fusion, cervical, spine