A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion

Status: Completed
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
Spine Institute of San Diego
San Diego
Connecticut
Connecticut Neck & Back Specialists, LLC
Danbury
Maryland
Anne Arundel Medical Group
Annapolis
Texas
Orthopedic Specialists of Austin
Austin
Time Frame
Start Date: 2018-05-14
Completion Date: 2021-06-30
Participants
Target number of participants: 95
Treatments
Cervical Fusion - ACDF
Up to 50 patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled.
Lumbar Interbody Fusion
Up to 50 patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.
Sponsors
Leads: Aziyo Biologics, Inc.

This content was sourced from clinicaltrials.gov