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

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ClinicalTrials.gov Identifier: NCT03786432
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Camber Spine Technologies
Information provided by (Responsible Party):
Jad Khalil MD, William Beaumont Hospitals

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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, 2020
Estimated Study Completion Date : December 31, 2022

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786432


Contacts
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Contact: Lisa L Motowski, BSN 248-551-6679 lisa.motowski@beaumont.org

Locations
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United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Lisa L Motowski, RN    248-551-6679    lisa.motowski@beaumont.org   
Principal Investigator: Jad G Khalil, MD         
Sub-Investigator: Jeffrey S Fischgrund, MD         
Sub-Investigator: Kevin C Baker, PhD         
Sponsors and Collaborators
William Beaumont Hospitals
Camber Spine Technologies
Investigators
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Principal Investigator: Jad G Khalil, MD William Beaumont Hospitals
  Study Documents (Full-Text)

Documents provided by Jad Khalil MD, William Beaumont Hospitals:

Publications:

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Responsible Party: Jad Khalil MD, Orthopaedic Spine surgeon and Assistant Professor of Orthopaedic Surgery, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03786432     History of Changes
Other Study ID Numbers: 2018-378
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases