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

Not Applicable

Terminated

Conditions: Cervical Radiculopathy
Cervical Disc Disease

Interventions: Device: Spira-C Interbody Device

Registration Number: NCT03786432

Lead Sponsor: William Beaumont Hospitals

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 13

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spira-C Interbody Device	Spira-C Interbody Device	40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device

Primary Outcome Measures

Name	Time	Method
Successful Cervical Fusion Measured Radiographically	12 months postoperative	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

Secondary Outcome Measures

Name	Time	Method
Decreased Neck Disability Index for Pain and Function	12 months postoperative	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.
Count of Participants With Development of Pseudoarthrosis by Month 12	12 months postoperative	Count of participants with development of pseudoarthrosis by month 12
Decreased Visual Analog Scale for Neck Pain	12 months postoperative	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.
Eating Assessment Tool-10 for Dysphagia	12 months postoperative	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.
Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)	12 months postoperative	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.
Worsening Neurological Deficit Per Cervical Spine Examination	12 months postoperative	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.
Count of Participants With Revision Surgery by Month 12	12 months postoperative	Count of participants with revision surgery by month 12