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Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine

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ClinicalTrials.gov Identifier: NCT01968993
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.

Brief Summary:
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the treated level(s). 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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Device: nanOss Bioactive - posterolateral gutter Not Applicable

Detailed Description:

The post market clinical investigation is designed to assess instrumented posterolateral fusion (PLF) using nanOss Bioactive bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1.

Preoperatively, the participant will provide his/her medical history and complete self assessment forms. The investigator will perform a clinical evaluation and x-rays will be performed if recent x-rays are not available. Participants will undergo instrumented PLF with an interbody fusion device (with autograft or allograft) using nanOss Bioactive in combination with autograft bone and bone marrow aspirate in one posterolateral gutter and autograft alone in the opposite posterolateral gutter.

Following surgery, operative and discharge information will be collected and a clinical evaluation will be performed prior to discharge. Participants will be evaluated 6 and 12 months postoperatively. One investigational site will participate in long-term followup of 24 months. Each participant will complete x-rays and self assessment documents. A CT scan performed at the 12 month postoperative visit will be evaluated by an independent radiologist to assess fusion results. Complication data will be recorded throughout the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using nanOss Bioactive and Autograft Bone.
Study Start Date : January 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nanOss Bioactive - posterolateral gutter
Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter.
Device: nanOss Bioactive - posterolateral gutter
Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter.




Primary Outcome Measures :
  1. Fusion [ Time Frame: 12 months ]
    Based on x-ray and CT scan. Defined as bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion. X-rays obtained at 6 months and 12 months. CT obtained at 12 months.


Secondary Outcome Measures :
  1. Improvement in Oswestry Disability Index score [ Time Frame: Preoperatively, 6 months, 12 months ]
    As compared to baseline levels

  2. Improvement in VAS pain scores [ Time Frame: Preoperatively, 6 months, 12 months ]
    As compared to baseline levels.

  3. Improvement in Short Form-36 scores (SF-36) [ Time Frame: Preoperatively, 6 months, 12 months ]
    As compared to baseline levels.

  4. Decrease in medication usage [ Time Frame: Preoperatively, 6 months, 12 months ]
    As compared to baseline levels.

  5. Work status [ Time Frame: Preoperatively, 6 months, 12 months ]
    As compared to baseline levels.

  6. Patient satisfaction [ Time Frame: Preoperatively, 6 months, 12 months ]
    As compared to baseline levels.


Other Outcome Measures:
  1. Complications, adverse events and neurological status [ Time Frame: 6 months, 12 months ]
    Incidence of reoperations, revisions, supplemental fixations, neurological failures, unexpected adverse events or complications will be calculated. Percentage of patients in each category will be reported and exact 95% confidence intervals will be calculated using the inverse beta distribution.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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% 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:

  • symptomatic at more than 2 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.
  • 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 100lbs over ideal body weight.
  • 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.
  • psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse.
  • active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
  • documented allergies to porcine collagen or titanium
  • pregnancy, or interested in becoming pregnant in the next four years.
  • participation in another investigational study within 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968993


Locations
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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
University of California San Francisco
San Francisco, California, United States, 94143
United States, Missouri
Columbia Orthopedic Group
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
Pioneer Surgical Technology, Inc.
Investigators
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Principal Investigator: Robert Eastlack, MD Scripps Green Hospital
Principal Investigator: Thomas Highland, MD Columbia Orthopedic Group

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Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT01968993     History of Changes
Other Study ID Numbers: 2010-02
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pioneer Surgical Technology, Inc.:
Degenerative Disc Disease
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis