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

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 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.

Inclusion Criteria:

1. ≥ 18 years of age and skeletally mature

2. Able to provide consent

3. Undergoing a primary, single-level ACDF between C3-C7

4. Diagnosis of symptomatic degenerative disc disease

5. Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4cm
(0-10cm scale)

6. Baseline Neck Disability Index score of ≥ 20

7. Attempted at least 6-weeks of conservative non-operative treatment

Exclusion Criteria:

1. Any prior history of cervical fusion

2. Requires cervical fusion of more than one level

3. Acute cervical spine trauma requiring immediate intervention

4. BMI > 40

5. Active systemic bacterial or fungal infection or infection at the operative site

6. History of vertebral fracture or osteoporotic fracture

7. Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid
therapy

8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal
surgery

9. Psychological or physical condition in the opinion of the investigator that would
interfere with completing study participation including completion of patient reported
outcomes

10. History of neurological condition in the opinion of the investigator that may affect
cervical spine function and pain assessments

11. Subjects with a history of cancer must be disease free for at least 3 years; with the
exception of squamous cell skin carcinoma

12. Pregnant, or plans on becoming pregnant

13. History of allergy to titanium