A Study Evaluating 3-Level OLIF Spine Fusion (NCT03896347) | Clinical Trial Compass
WithdrawnNot Applicable
A Study Evaluating 3-Level OLIF Spine Fusion
Stopped: Lack of enrollment
0Started 2019-07-01
Plain-language summary
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Subjects will be followed for 12 months following surgery to assess degree of mineralization via computed tomography (CT) scan at 6 and 12 months, mean time to fusion, and maturation of fusion mass postoperatively via x-ray radiograph.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria
* Male or female, 18-80 years of age
* Patient must have degenerative disc disease, defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, affecting three contiguous levels between L2 and S1. Affected levels may also have up to Grade 1 spondylolisthesis or retrolisthesis
* Patient must have at least 6 months on non-operative treatment prior to study enrollment
* Patient signed Informed Consent Form
* Patient signed HIPAA Authorization (may be part of the ICF)
* Appropriate candidate for OLIF surgery using ViBone®, DBM, and BMP)
* Patient will adhere to the scheduled follow-up visits and requirements of the protocol
* Routine patient exams include pre-operative, operative, and three post-operative visits (3, 6, and 12 months post-surgery)
* CT scan of surgical site 6 and 12 months post-surgery
Exclusion Criteria
* Long-term, chronic use of medications that are known to inhibit fusion, bone metabolism, or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
* Treatment with radiotherapy
* Patients who have who have had surgery for primary tumors or metastatic malignant tumors of the lumbar or sacral 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 are eligible.
* Inability to provi…