Study Using the CervicalStim Device Following Cervical Fusion

Completed

Conditions studied: Vertebral Cervical Fusion Syndrome, Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT03177473

Run by

Orthofix Inc.

People needed

211

Starts

2017-06-28

Expected to finish

2021-08-03

Last updated by the study team

2022-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• a. 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
• 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).
• 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.
• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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