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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CervicalStim PEMF group | all subjects will receive active CervicalStim bone growth stimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CervicalStim bone growth stimulator | Device | Orthofix CervicalStim bone growth stimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| cervical fusion rate | fusion rate assessed via radiographic confirmation (Xray and CT) | 12 months |
| 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 |
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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.
a. Surgical approach is at the physician's discretion.
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).
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).
Exclusion Criteria:
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Subjects from all over the United States will be eligible for enrollment as long as they meet the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| James T Ryaby, PhD | Orthofix Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinTech Center for Spine Health | Johnstown | Colorado | 80534 | United States |
if we decide to share, we will share only deidentified summary data
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| ID | Term |
|---|---|
| D007714 | Klippel-Feil Syndrome |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013122 | Spinal Diseases |