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

• ClinicalTrials.gov Identifier: NCT03786432
• Recruitment Status: Active, not recruiting
• First Posted: December 26, 2018
• Last Update Posted: February 1, 2022
• Sponsor: William Beaumont Hospitals
• Collaborator: Camber Spine Technologies
• Information provided by (Responsible Party): Jad Khalil MD, William Beaumont Hospitals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Radiculopathy; Cervical Disc Disease	Device: Spira-C Interbody Device	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 10, 2019
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Spira-C Interbody Device; 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device	Device: Spira-C Interbody Device; 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device

Outcome Measures

Primary Outcome Measures :

1. Incidence of successful cervical fusion measured radiographically [ Time Frame: 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 :

1. Visual Analog Scale for Pain [ Time Frame: 12 months postoperative ]
   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.
2. Neck Disability Index for Pain and Function [ Time Frame: 12 months postoperative ]
   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.
3. Short Form Health Survey-36 for Quality of Life [ Time Frame: 12 months postoperative ]
   Equal to or greater than 15-point increase in patient reported outcomes 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.
4. Eating Assessment Tool-10 for Dysphagia [ Time Frame: 12 months postoperative ]
   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.
5. Neurological Deficit per Cervical Spine Examination [ Time Frame: 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.
6. Count of participants with revision surgery by month 12 [ Time Frame: 12 months postoperative ]
   Count of participants with revision surgery by month 12
7. Count of participants with development of pseudoarthrosis by month 12 [ Time Frame: 12 months postoperative ]
   Count of participants with development of pseudoarthrosis by month 12

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Michigan

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Camber Spine Technologies

Investigators

• Principal Investigator: Jad G Khalil, MD; William Beaumont Hospitals

  Study Documents (Full-Text)

Documents provided by Jad Khalil MD, William Beaumont Hospitals:

Study Protocol and Statistical Analysis Plan  [PDF] December 12, 2018

More Information

Publications:

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.

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;17:379. doi: 10.1186/s12891-016-1234-1.

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.

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. Review.

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. Review.

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.

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.

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.

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. Review.

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. Review.

• Responsible Party: Jad Khalil MD, Orthopaedic Spine surgeon and Assistant Professor of Orthopaedic Surgery, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT03786432
• Other Study ID Numbers: 2018-378
• First Posted: December 26, 2018
• Last Update Posted: February 1, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Radiculopathy; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases