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

NCT03786432 | Terminated Results DMC FDA Device

• 1 other identifier: 2018-378
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy; Cervical Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Decreased Visual Analog Scale for Neck Pain

  12 months postoperative

• Decreased Neck Disability Index for Pain and Function

  12 months postoperative

• Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)

  12 months postoperative

• Eating Assessment Tool-10 for Dysphagia

  12 months postoperative

• Worsening Neurological Deficit Per Cervical Spine Examination

  12 months postoperative

Study Arms (1)

Spira-C Interbody Device

EXPERIMENTAL

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

Device: Spira-C Interbody Device

Interventions

Spira-C Interbody Device DEVICE

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

Spira-C Interbody Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead
• Camber Spine Technologies: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (10)

• 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.

  PMID: 29496624 BACKGROUND

• 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.

  PMID: 27585553 BACKGROUND

• 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.

  PMID: 22978810 BACKGROUND

• 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.

  PMID: 24890288 BACKGROUND

• 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.

  PMID: 29805806 BACKGROUND

• 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.

  PMID: 20124907 BACKGROUND

• 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.

  PMID: 24827519 BACKGROUND

• 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.

  PMID: 23568254 BACKGROUND

• 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.

  PMID: 28736113 BACKGROUND

• 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.

  PMID: 29057355 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Early termination leading to small numbers of participants analyzed.

Results Point of Contact

• Title: Grace San Agustin
• Organization: William Beaumont University Hospital

grace.sanagustin@beaumont.org

248 551 6679

Study Officials

• Jad G Khalil, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Spine surgeon and Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: January 10, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)