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Study Using the CervicalStim Device Following Cervical Fusion

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ClinicalTrials.gov Identifier: NCT03177473
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.

Brief Summary:
This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. All participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.

Condition or disease Intervention/treatment
Vertebral Cervical Fusion Syndrome Degenerative Disc Disease Device: CervicalStim bone growth stimulator

Detailed Description:
The purpose of this post market prospective study is to examine the effect of the adjunctive use of the Orthofix CervicalStim device on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. High risk subjects are those who are having a multi-level (2 or more) cervical fusion, who are smokers, who are diabetic or those who are osteoporotic. Because this is a post market prospective study, subjects who are enrolled in this study will be identified by the Investigator as needing cervical fusion surgery and asked to participate in a study looking at the efficacy of cervical fusion with adjunctive use of the CervicalStim bone growth simulator. The type of cervical fusion surgery performed is up to the Investigator; the subjects in the study must be agreeable to using the bone growth stimulator for 6 months post-surgery. The subjects will be followed for 12 months.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: A Multi-Center, Open-Label, Prospective Study of CervicalStim Device™ as Adjunctive Care Following Cervical Fusion
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : July 10, 2020
Estimated Study Completion Date : September 30, 2021


Group/Cohort Intervention/treatment
CervicalStim PEMF group
all subjects will receive active CervicalStim bone growth stimulator
Device: CervicalStim bone growth stimulator
Orthofix CervicalStim bone growth stimulator




Primary Outcome Measures :
  1. cervical fusion rate [ Time Frame: 12 months ]
    fusion rate assessed via radiographic confirmation (Xray and CT)


Secondary Outcome Measures :
  1. Device Compliance [ Time Frame: 6 months ]
    actual minutes per day device was used compared with prescribed use

  2. revision rate [ Time Frame: 12 months ]
    how many subjects had to be revised at the same level(s) during the course of the study

  3. SF-36 [ Time Frame: 12 months ]
    used to assess the effect of PEMF therapy on the subject's quality of life

  4. Neck Disability Index (NDI) [ Time Frame: 12 months ]
    used to assess the effect of PEMF therapy on the reduction of neck pain

  5. EQ-5D [ Time Frame: 12 months ]
    used to assess the effect of PEMF therapy on quality of life as well as economic impact

  6. VAS pain [ Time Frame: 12 months ]
    used to assess the effect of PEMF therapy on reduction of pain



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
Sampling Method:   Non-Probability Sample
Study Population
Subjects from all over the United States will be eligible for enrollment as long as they meet the inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  1. Male or female, ≥ 18 years of age at the time of Informed Consent.
  2. Requires a cervical fusion surgery within 30 days of Informed Consent signing.

    a. Surgical approach is at the physician's discretion.

  3. Subject has one or more high risk factors:

    1. Is currently using nicotine
    2. multi-level cervical fusion surgery planned
    3. Prior failed fusion at any cervical level
    4. Subject reported diabetes
    5. Subject reported osteoporosis
  4. Body mass index ≤ 45 kg/m2 at the time of consent.
  5. Must have reliable access to an iPhone or an iPad with Wi-Fi access for downloading the free device-specific app (iPhone 5S or higher, iPad, iPad Pro, iPad mini or iTouch using iOS v.9.3 or later).

    a. When the android version of the mobile app for the CervicalStim device becomes available (estimated to be Dec. 2017), subjects who have reliable access to devices using android operating systems will be eligible for study inclusion.

  6. Able and willing to complete electronic questionnaires and able to read and understand study instructions in English.
  7. Able and willing to comply with the study plan and able to understand and sign the study-specific Informed Consent Form (ICF).

Exclusion Criteria:

  1. Current alcoholism and/or any known current addiction to pain medications.
  2. Any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin).
  3. Any clinically significant finding that places the subject at health risk, impacts the study, or affects completion of the study, in the opinion of the Investigator.
  4. Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator.
  5. Subject is a prisoner.

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): NCT03177473


Locations
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United States, Colorado
ClinTech Center for Spine Health
Johnstown, Colorado, United States, 80534
Sponsors and Collaborators
Orthofix Inc.
Investigators
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Principal Investigator: James T Ryaby, PhD Orthofix Inc.
Additional Information:

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Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT03177473    
Other Study ID Numbers: CP-1703CSPM
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: if we decide to share, we will share only deidentified summary data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Orthofix Inc.:
degenerative disc disease
CervicalStim devic
cervical
cervical fusion
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Klippel-Feil Syndrome
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dysostoses
Bone Diseases, Developmental
Musculoskeletal Abnormalities
Congenital Abnormalities