CompletedNot Applicable

Study Using the CervicalStim Device Following Cervical Fusion

United States211 participantsStarted 2017-06-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. Is currently using nicotine
. multi-level cervical fusion surgery planned
. Prior failed fusion at any cervical level
. Subject reported diabetes
. Subject reported osteoporosis

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cervical fusion rate

Timeframe: 12 months

Trial details

NCT IDNCT03177473

SponsorOrthofix Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-08-03

View on ClinicalTrials.gov More Vertebral Cervical Fusion Syndrome trials