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

November 7, 2016 updated by: Pioneer Surgical Technology, Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90048
        • Tower Orthopaedics & Neurosurgical Spine Institute
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital Neurosurgery
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Facility
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Advanced Center for Orthopedics
    • Missouri
      • Springfield, Missouri, United States, 65804
        • St. Johns Spine and Pain Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Neurology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Milwaukee Spinal Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The patient can be included in the study if all of the following criteria are met;

  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:

The patient must not exhibit any of the following 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
  20. participation in another investigational study within 30 days *Osteoporosis will be assessed at the time of the preoperative evaluation based on the patient"s history, physical examination and review of the radiographic evaluations. All patients at risk for osteoporosis must obtain a DEXA scan of the spine and hip to determine if the patient has severe osteoporosis. The definition of a patient at risk used by the National Osteoporosis Foundation includes the following: i. Premature menopause (< 45 years) ii. Prolonged amenorrhea (> one year) iii. Maternal history of hip fracture iv. Primary hyperparathyroidism or hyperthyroidism v. Chronic renal failure vi. Previous fragility fractures, particularly of the hip, spine or wrist vii. Patients who have ever taken corticosteroids in doses >7.5 mg/day for one year or more. Patients will be excluded if their bone mineral density (BMD) in the spine or hip is more than 1.0 standard deviation (SD) below the mean of normal adults in the presence of one or more fragility fractures indicating severe osteoporosis. If severe osteoporosis is diagnosed, the patient must be excluded from the investigational study. If the patient has osteoporosis or osteopenia, they may be included in the study if he or she meets the rest of the inclusion and exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal fusion
Time Frame: 12 months
  1. Bridging trabecular bone
  2. Less than 3mm of translational motion
  3. Less than 5mm of angular motion
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in Oswestry Disability Index score
Time Frame: 12 months
12 months
Improvement in VAS pain scores
Time Frame: 12 months
12 months
Improvement in Quality of Life scores
Time Frame: 12 months
12 months
Decrease in medication usage
Time Frame: 12 months
12 months
Patient returning to work
Time Frame: 12 months
12 months
Patient satisfaction (surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mathew Songer, MD, Advanced Center for Orthopedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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