Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery

Study Overview
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Brief Summary
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The objective of this study is to perform a prospective, single-arm clinical evaluation utilizing the Spira™-C 3-D printed titanium interbody device for treatment of degenerative disc disease and spinal stenosis of the cervical spine to evaluate fusion status and patient reported outcomes. The primary objective is fusion status or bony healing within the device. Patient reported outcomes, i.e. pain, function, and quality of life will also be measured postoperatively.

Detailed Description
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This is a post-market, single-arm, prospective clinical study to evaluate fusion status and patient reported outcomes using the Spira-C titanium interbody cage for degenerative disc disease where single-level ACDF surgery is indicated. The treatment group will consist of 40 subjects treated with the Spira™-C interbody device at one level. Patients with a diagnosis of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and planning to undergo a 1-level ACDF surgery between C3-C7 will be screened and consented, if eligibility requirements are met. Once the subject has been enrolled and the surgery has taken place; data will be collected regarding the surgical details will be collected. Subjects will be followed up postoperatively at 6-weeks, 3-months, 6-months, and 12-months as per standard of care, at the private practice or clinic. Subjects will be asked to complete questionnaires regarding pain, function, and quality of life before and after surgery during the postoperative follow-up visits. Radiographic assessments will be performed at all postoperative visits; fusion status will be measured using cervical x-rays and CT scan at 12 months. Radiographs will also be utilized to assess for device-related complications, including implant failure. Any clinically significant complications related to the device will be recorded as an adverse event. This study design reflects the current standard of care for cervical degenerative disc disease and spinal stenosis with symptoms of radiculopathy or myelopathy. Data collected from subjects treated with the Spira™-C Interbody Device will be compared to historical data based on literature review of polyetheretherketone (PEEK) cage fusion rates and patient reported outcomes. Anterior cervical discectomy and fusion using an interbody device with plate and screw fixation is the treatment of choice after conservative therapies (non-surgical, i.e., physical therapy, epidural steroid injections, pain medications) have been exhausted.

Official Title
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A Prospective Clinical Pilot Study Of Fusion Rates Using Spira™-C Titanium 3-D Printed Interbody Device For Anterior Cervical Discectomy And Fusion

Conditions
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Cervical Radiculopathy, Cervical Disc Disease

Intervention / Treatment
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* Device: Spira-C Interbody Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age and skeletally mature Able to provide consent Undergoing a primary, single-level ACDF between C3-C7 Diagnosis of symptomatic degenerative disc disease Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4cm (0-10cm scale) Baseline Neck Disability Index score of ≥ 20 Attempted at least 6-weeks of conservative non-operative treatment Exclusion Criteria: Any prior history of cervical fusion Requires cervical fusion of more than one level Acute cervical spine trauma requiring immediate intervention BMI > 40 Active systemic bacterial or fungal infection or infection at the operative site History of vertebral fracture or osteoporotic fracture Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma Pregnant, or plans on becoming pregnant History of allergy to titanium

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spira-C Interbody Device<br>40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device | Device: Spira-C Interbody Device<br>* 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Cervical Fusion Measured Radiographically | Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level | 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased Visual Analog Scale for Neck Pain | Count of participants with equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months in the neck region. | 12 months postoperative | 
| Decreased Neck Disability Index for Pain and Function | Count of participants with equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount disability, 100 = most severe disability) from baseline to 12-months. | 12 months postoperative | 
| Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36) | Count of participants with Equal to or greater than 15-point increase in patient reported general health score as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months. | 12 months postoperative | 
| Eating Assessment Tool-10 for Dysphagia | Count of participants with score of less than 3 or equal to baseline in patient reported outcomes as measured by Eating Assessment Tool-10 from baseline to 12-months. | 12 months postoperative | 
| Worsening Neurological Deficit Per Cervical Spine Examination | Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine (motor and sensory) examination from baseline to 12-months. | 12 months postoperative | 
| Count of Participants With Revision Surgery by Month 12 | Count of participants with revision surgery by month 12 | 12 months postoperative | 
| Count of Participants With Development of Pseudoarthrosis by Month 12 | Count of participants with development of pseudoarthrosis by month 12 | 12 months postoperative |