Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
NCT ID: NCT01452516
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
28 participants
INTERVENTIONAL
2010-07-31
2013-09-30
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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nanOss Bioactive Bone void filler
Lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
nanOss Bioactive Bone void filler
Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
Interbody FCage
Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion
Interventions
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nanOss Bioactive Bone void filler
Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
Interbody FCage
Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion
Eligibility Criteria
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Inclusion Criteria
1. is at least 18 years of age and skeletally mature
2. 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
3. must have completed a minimum of three months of unsuccessful conservative, non-operative care
4. must have discogenic back pain with or without leg pain
5. DDD must be confirmed by MRI or CT scans followed by discography (if necessary)
6. must score at least 40 points on the Oswestry Disability Index
7. must score at least a 4 on a 10 cm Visual Analog Scale for back pain
8. must be able to comply with the protocol"s follow-up schedule
9. must understand and sign the informed consent document
Exclusion Criteria
1. symptomatic at more than two levels
2. 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)
3. more than 50% spondylolisthesis
4. lumbar scoliosis greater than 11 degrees
5. osteoporosis\*, osteopenia, osteomalacia, Paget"s disease or metabolic bone disease.
6. spinal tumors
7. active arachnoiditis Pioneer Surgical Technology Confidential nanOss Bioactive Post Marketing Clinical Study: March 11, 2010 Page 8
8. fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
9. Impaired calcium metabolism
10. active infection or surgical site infection
11. rheumatoid arthritis or other autoimmune disease
12. chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing
13. systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
14. morbid obesity defined as body mass index (BMI) \>40 or a weight more than 100 lbs over ideal body weight
15. smokers unless the patient agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery
16. psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse
17. active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years
18. documented allergies to porcine collagen or titanium
19. pregnancy, or interested in becoming pregnant in the next four years
18 Years
ALL
No
Sponsors
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Pioneer Surgical Technology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mathew Songer, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Center for Orthopedics
Locations
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Tower Orthopaedics & Neurosurgical Spine Institute
Beverly Hills, California, United States
Scripps Memorial Hospital Neurosurgery
La Jolla, California, United States
Northwestern Medical Facility
Chicago, Illinois, United States
Advanced Center for Orthopedics
Marquette, Michigan, United States
St. Johns Spine and Pain Clinic
Springfield, Missouri, United States
Medical University of South Carolina Neurology
Charleston, South Carolina, United States
Milwaukee Spinal Specialists
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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B01-2010
Identifier Type: -
Identifier Source: org_study_id