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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
William Beaumont Hospitals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Camber Spine Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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