Study Using the CervicalStim Device Following Cervical Fusion

A Multi-Center, Open-Label, Prospective Study of CervicalStim Device™ as Adjunctive Care Following Cervical Fusion

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Vertebral Cervical Fusion Syndrome
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Johnstown, Colorado, United States, 80534
      • ClinTech Center for Spine Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical fusion rate	fusion rate assessed via radiographic confirmation (Xray and CT)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Compliance	actual minutes per day device was used compared with prescribed use	6 months
revision rate	how many subjects had to be revised at the same level(s) during the course of the study	12 months
SF-36	used to assess the effect of PEMF therapy on the subject's quality of life	12 months
Neck Disability Index (NDI)	used to assess the effect of PEMF therapy on the reduction of neck pain	12 months
EQ-5D	used to assess the effect of PEMF therapy on quality of life as well as economic impact	12 months
VAS pain	used to assess the effect of PEMF therapy on reduction of pain	12 months

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: Principal Investigator: James T Ryaby, PhD, Orthofix Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2017
• Primary Completion (ACTUAL): August 3, 2021
• Study Completion (ACTUAL): August 3, 2021

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: cervical; degenerative disc disease; CervicalStim devic; cervical fusion
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Intervertebral Disc Degeneration; Klippel-Feil Syndrome
• Other Study ID Numbers: CP-1703CSPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: if we decide to share, we will share only deidentified summary data

Drug and device information, study documents

• 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