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

NCT01452516 | Terminated

• 1 other identifier: B01-2010
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

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.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis

Keywords

PLF; lumbar fusion; bone graft; biologics

Outcome Measures

Primary Outcomes (1)

• Spinal fusion

  1. Bridging trabecular bone 2. Less than 3mm of translational motion 3. Less than 5mm of angular motion

  12 months

Secondary Outcomes (6)

• Improvement in Oswestry Disability Index score

  12 months

• Improvement in VAS pain scores

  12 months

• Improvement in Quality of Life scores

  12 months

• Decrease in medication usage

  12 months

• Patient returning to work

  12 months

Study Arms (1)

nanOss Bioactive Bone void filler

OTHER

Lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler

Device: nanOss Bioactive Bone void filler; Device: Interbody FCage

Interventions

nanOss Bioactive Bone void filler DEVICE

Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler

nanOss Bioactive Bone void filler

Interbody FCage DEVICE

Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion

nanOss Bioactive Bone void filler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• active infection or surgical site infection
• rheumatoid arthritis or other autoimmune disease
• 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
• systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
• morbid obesity defined as body mass index (BMI) \>40 or a weight more than 100 lbs over ideal body weight

Sponsors & Collaborators

• Pioneer Surgical Technology, Inc.: lead

Study Sites (7)

Tower Orthopaedics & Neurosurgical Spine Institute

Beverly Hills, California, 90048, United States

Location

Scripps Memorial Hospital Neurosurgery

La Jolla, California, 92037, United States

Location

Northwestern Medical Facility

Chicago, Illinois, 60611, United States

Location

Advanced Center for Orthopedics

Marquette, Michigan, 49855, United States

Location

St. Johns Spine and Pain Clinic

Springfield, Missouri, 65804, United States

Location

Medical University of South Carolina Neurology

Charleston, South Carolina, 29425, United States

Location

Milwaukee Spinal Specialists

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Mathew Songer, MD

  Advanced Center for Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: October 17, 2011
• Study Start: July 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)