NCT01452516

Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions

A Prospective, Multi-Center, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pioneer Surgical Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to obtain new bone growth during the healing process. It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion. In addition, patients are expected to see an improvement in Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the use of pain medication, returning to work, and finding satisfaction in the results of their surgery.

Detailed description

The post marketing clinical trial is designed to assess lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler in patients with degenerative disc disease (DDD) characterized by the inclusion and exclusion criteria listed below. Patients for this study will be recruited from up to 10 clinical sites. It is estimated that 100 patients will be enrolled in the study. At least 10 investigators will participate in the study. Patients who meet the inclusion and exclusion criteria will be asked to sign the informed consent. Preoperatively, the patient will provide his /her medical history and complete self assessment forms. The investigator will perform a clinical evaluation. Patients who meet the criteria for entrance into the study will undergo lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive in combination with local autograft and bone marrow aspirate (BMA). Anterior lumbar interbody fusion procedures are not allowed. Following surgery, operative and discharge information will be collected. The patients will be evaluated at 6 weeks, 6 months and 12 months postoperatively. At each postoperative visit, the investigator will clinically evaluate the patient and the patient will complete self assessment documents, Oswestry Disability Index, Quality of Life questionnaires and a surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery. Fusion status will be evaluated radiographically at each visit using plain films. CT scans at 12 months will be evaluated by an independent radiologist. Complication data will be recorded throughout the study.

Conditions

• Degenerative Disc Disease
• Spinal Stenosis
• Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	nanOss Bioactive Bone void filler	Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
DEVICE	Interbody FCage	Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-10-17
• Last updated: 2016-12-07

Locations

7 sites across 1 country: United States