ViBone in Cervical and Lumbar Spine Fusion (NCT03425682) | Clinical Trial Compass
CompletedNot Applicable
ViBone in Cervical and Lumbar Spine Fusion
United States118 participantsStarted 2018-05-14
Plain-language summary
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, 18-80 years of age
* For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
* For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
* Patient signed Consent Form with HIPAA Authorization
* Appropriate candidate for surgery
* Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).
Exclusion Criteria:
* Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
* Treatment with radiotherapy
* Acute or chronic systemic or localized spinal infections
* Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
* Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
* TLIF, PLIF, ALIF, or LLIF patients) spine
* Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
* Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma …
What they're measuring
1
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale