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

Cervical Radiculopathy Clinical Trial

— ACDF  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03786432
• Other study ID #: 2018-378
• Status: Terminated
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Disease
• Cervical Radiculopathy
• Radiculopathy

Intervention

Device:
• Spira-C Interbody Device
40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Camber Spine Technologies

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View Citation

Hsu MR, Haleem MS, Hsu W. 3D Printing Applications in Minimally Invasive Spine Surgery. Minim Invasive Surg. 2018 Apr 1;2018:4760769. doi: 10.1155/2018/4760769. eCollection 2018. — View 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. — View 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. — View 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. — View 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. — View Citation

Rao PJ, Pelletier MH, Walsh WR, Mobbs RJ. Spine interbody implants: material selection and modification, functionalization and bioactivation of surfaces to improve osseointegration. Orthop Surg. 2014 May;6(2):81-9. doi: 10.1111/os.12098. — View 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. — View Citation

Wilcox B, Mobbs RJ, Wu AM, Phan K. Systematic review of 3D printing in spinal surgery: the current state of play. J Spine Surg. 2017 Sep;3(3):433-443. doi: 10.21037/jss.2017.09.01. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Count of Participants With Revision Surgery by Month 12	Count of participants with revision surgery by month 12	12 months postoperative
Secondary	Count of Participants With Development of Pseudoarthrosis by Month 12	Count of participants with development of pseudoarthrosis by month 12	12 months postoperative