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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Pioneer Surgical Technology, Inc.
- Enrollment
- 28
- Locations
- 7
- Primary Endpoint
- Spinal fusion
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient can be included in the study if all of the following criteria are met;
- •is at least 18 years of age and skeletally mature
- •must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1 requiring a fusion
- •must have completed a minimum of three months of unsuccessful conservative, non-operative care
- •must have discogenic back pain with or without leg pain
- •DDD must be confirmed by MRI or CT scans followed by discography (if necessary)
- •must score at least 40 points on the Oswestry Disability Index
- •must score at least a 4 on a 10 cm Visual Analog Scale for back pain
- •must be able to comply with the protocol"s follow-up schedule
- •must understand and sign the informed consent document
Exclusion Criteria
- •The patient must not exhibit any of the following criteria;
- •symptomatic at more than two levels
- •previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level \> 6 months is permitted)
- •more than 50% spondylolisthesis
- •lumbar scoliosis greater than 11 degrees
- •osteoporosis\*, osteopenia, osteomalacia, Paget"s disease or metabolic bone disease.
- •spinal tumors
- •active arachnoiditis Pioneer Surgical Technology Confidential nanOss Bioactive Post Marketing Clinical Study: March 11, 2010 Page 8
- •fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- •Impaired calcium metabolism
Outcomes
Primary Outcomes
Spinal fusion
Time Frame: 12 months
1. Bridging trabecular bone 2. Less than 3mm of translational motion 3. Less than 5mm of angular motion
Secondary Outcomes
- Improvement in Oswestry Disability Index score(12 months)
- Improvement in Quality of Life scores(12 months)
- Patient satisfaction (surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery)(12 months)
- Improvement in VAS pain scores(12 months)
- Decrease in medication usage(12 months)
- Patient returning to work(12 months)