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

July 11, 2023 updated by: Jad Khalil MD, William Beaumont Hospitals

A Prospective Clinical Pilot Study Of Fusion Rates Using Spira™-C Titanium 3-D Printed Interbody Device For Anterior Cervical Discectomy And Fusion

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Visual Analog Scale for Neck Pain
Time Frame: 12 months postoperative
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
Decreased Neck Disability Index for Pain and Function
Time Frame: 12 months postoperative
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
Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)
Time Frame: 12 months postoperative
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
Eating Assessment Tool-10 for Dysphagia
Time Frame: 12 months postoperative
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
Worsening 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.
12 months postoperative
Count of Participants With Revision Surgery by Month 12
Time Frame: 12 months postoperative
Count of participants with revision surgery by month 12
12 months postoperative
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
12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Collaborators

Camber Spine Technologies

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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