Clinical trial NCT03786432: Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery
Official title: A Prospective Clinical Pilot Study Of Fusion Rates Using Spira™-C Titanium 3-D Printed Interbody Device For Anterior Cervical Discectomy And Fusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Radiculopathy
Cervical Disc Disease
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Camber Spine Technologies
First posted: 2018-12-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Cervical Fusion Measured Radiographically
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Decreased Visual Analog Scale for Neck Pain
timeFrame: 12 months postoperative
measure: Decreased Neck Disability Index for Pain and Function
timeFrame: 12 months postoperative
measure: Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)
timeFrame: 12 months postoperative
measure: Eating Assessment Tool-10 for Dysphagia
timeFrame: 12 months postoperative
measure: Worsening Neurological Deficit Per Cervical Spine Examination
timeFrame: 12 months postoperative
measure: Count of Participants With Revision Surgery by Month 12
timeFrame: 12 months postoperative
measure: Count of Participants With Development of Pseudoarthrosis by Month 12
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Jad G Khalil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26.
citation: Li ZJ, Wang Y, Xu GJ, Tian P. Is PEEK cage better than titanium cage in anterior cervical discectomy and fusion surgery? A meta-analysis. BMC Musculoskelet Disord. 2016 Sep 1;17(1):379. doi: 10.1186/s12891-016-1234-1.
citation: Cabraja M, Oezdemir S, Koeppen D, Kroppenstedt S. Anterior cervical discectomy and fusion: comparison of titanium and polyetheretherketone cages. BMC Musculoskelet Disord. 2012 Sep 14;13:172. doi: 10.1186/1471-2474-13-172.
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citation: Niu CC, Liao JC, Chen WJ, Chen LH. Outcomes of interbody fusion cages used in 1 and 2-levels anterior cervical discectomy and fusion: titanium cages versus polyetheretherketone (PEEK) cages. J Spinal Disord Tech. 2010 Jul;23(5):310-6. doi: 10.1097/BSD.0b013e3181af3a84.
citation: Lee YS, Kim YB, Park SW. Risk factors for postoperative subsidence of single-level anterior cervical discectomy and fusion: the significance of the preoperative cervical alignment. Spine (Phila Pa 1976). 2014 Jul 15;39(16):1280-7. doi: 10.1097/BRS.0000000000000400.
citation: Chen Y, Wang X, Lu X, Yang L, Yang H, Yuan W, Chen D. Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up. Eur Spine J. 2013 Jul;22(7):1539-46. doi: 10.1007/s00586-013-2772-y. Epub 2013 Apr 9.
citation: Seaman S, Kerezoudis P, Bydon M, Torner JC, Hitchon PW. Titanium vs. polyetheretherketone (PEEK) interbody fusion: Meta-analysis and review of the literature. J Clin Neurosci. 2017 Oct;44:23-29. doi: 10.1016/j.jocn.2017.06.062. Epub 2017 Jul 21.
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