Vertebral Cervical Fusion SyndromeNCT03177473
Study Using the CervicalStim Device Following Cervical Fusion
An observational study of Vertebral Cervical Fusion Syndrome and Degenerative Disc Disease, run by Orthofix Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Cervical Fusion Syndrome, Degenerative Disc Disease
- What is being tested?
- CervicalStim bone growth stimulator
- Type of treatment
- Medical device
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 3 Aug 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects from all over the United States will be eligible for enrollment as long as they meet the inclusion/exclusion criteria.
Who may be able to join
- Male or female, ≥ 18 years of age at the time of Informed Consent.
- Requires a cervical fusion surgery within 30 days of Informed Consent signing.
- Surgical approach is at the physician's discretion.
- Subject has one or more high risk factors:
- Is currently using nicotine
- multi-level cervical fusion surgery planned
Show all 14Show fewer
- Prior failed fusion at any cervical level
- Subject reported diabetes
- Subject reported osteoporosis
- Body mass index ≤ 45 kg/m2 at the time of consent.
- 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).
- 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.
- Able and willing to complete electronic questionnaires and able to read and understand study instructions in English.
- Able and willing to comply with the study plan and able to understand and sign the study-specific Informed Consent Form (ICF).
Who cannot join
- Current alcoholism and/or any known current addiction to pain medications.
- Any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin).
- 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.
- Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator.
- Subject is a prisoner.
Trial locations and contacts
1 site in 1 country.
United States1 site
ClinTech Center for Spine Health
Johnstown, Colorado, 80534
About this study
Official title: 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.
Read the 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.
- Being tested
- CervicalStim bone growth stimulator
- Keywords
- degenerative disc disease, CervicalStim devic, cervical, cervical fusion
- Medical subject headings
- Klippel-Feil Syndrome, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervicalStim bone growth stimulatorDevice
Orthofix CervicalStim bone growth stimulator
| Study group | Role | What they receive |
|---|---|---|
| CervicalStim PEMF group | all subjects will receive active CervicalStim bone growth stimulator Receives: Device: CervicalStim bone growth stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical fusion rate
fusion rate assessed via radiographic confirmation (Xray and CT)
Measured: 12 months
Secondary outcomes (6)
Device Compliance
actual minutes per day device was used compared with prescribed use
Measured: 6 months
revision rate
how many subjects had to be revised at the same level(s) during the course of the study
Measured: 12 months
SF-36
used to assess the effect of PEMF therapy on the subject's quality of life
Measured: 12 months
Neck Disability Index (NDI)
used to assess the effect of PEMF therapy on the reduction of neck pain
Measured: 12 months
EQ-5D
used to assess the effect of PEMF therapy on quality of life as well as economic impact
Measured: 12 months
VAS pain
used to assess the effect of PEMF therapy on reduction of pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start28 Jun 2017
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Cervical Fusion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James T Ryaby, PhD, Principal investigator, Orthofix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177473
- Sponsor's protocol ID
- CP-1703CSPM
- Status last verified
- Sep 2022
- First submitted
- 27 Apr 2017
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: if we decide to share, we will share only deidentified summary data
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Prospective Study of CervicalStim Device™ as Adjunctive Care Following Cervical Fusion
- ClinicalTrials.gov ID
- NCT03177473
- Acronym / sponsor ID
- CP-1703CSPM
- Keywords
- degenerative disc disease, CervicalStim devic, cervical, cervical fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CervicalStim PEMF group | – | Device: CervicalStim bone growth stimulatorall subjects will receive active CervicalStim bone growth stimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from all over the United States will be eligible for enrollment as long as they meet the inclusion/exclusion criteria.
Key inclusion criteria (14 listed)
- Male or female, ≥ 18 years of age at the time of Informed Consent.
- Requires a cervical fusion surgery within 30 days of Informed Consent signing.
- Subject has one or more high risk factors:
- Body mass index ≤ 45 kg/m2 at the time of consent.
- 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).
Key exclusion criteria (5 listed)
- Current alcoholism and/or any known current addiction to pain medications.
- Any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin).
- 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.
- Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator.
- Subject is a prisoner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CervicalStim bone growth stimulatorOrthofix CervicalStim bone growth stimulator | Device | CervicalStim PEMF group |
Primary outcome
cervical fusion rate
Time frame: 12 months
fusion rate assessed via radiographic confirmation (Xray and CT)
6 secondary outcomes
Device Compliance
Time frame: 6 months
revision rate
Time frame: 12 months
SF-36
Time frame: 12 months
Neck Disability Index (NDI)
Time frame: 12 months
EQ-5D
Time frame: 12 months
VAS pain
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: Undecided. if we decide to share, we will share only deidentified summary data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Ryaby, PhD principal investigator
Orthofix Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Cervical Fusion Syndrome and Degenerative Disc Disease, run by Orthofix Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical fusion rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022; AzTrials last refreshed its copy on 27 Oct 2026.