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 range18 Years

SexALL

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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.
✕. Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator.
✕. Subject is a prisoner.

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