Status:
TERMINATED
Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery
Lead Sponsor:
Corewell Health East
Collaborating Sponsors:
Camber Spine Technologies
Conditions:
Cervical Radiculopathy
Cervical Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 spin...
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 sing...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03786432
Start Date
January 10 2019
End Date
June 30 2022
Last Update
July 28 2023
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073