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Assessment of nanOss Bioactive 3D in the Posterolateral Spine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01829997
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.

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 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process.

nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D 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 3D BVF Not Applicable

Detailed Description:

The post market clinical investigation is designed to assess instrumented PLF using nanOss Bioactive 3D bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1 characterized by the inclusion and exclusion criteria.

Patients will be evaluated at Preop, discharge, 6 and 12 months. X-rays will be obtained at each visit; Additionally, a CT scan will be performed at the 12 month postoperative visit to assess fusion status.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Post-Market Assessment Of NanOss Bioactive 3D in the Posterolateral Spine
Study Start Date : April 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: nanOss Bioactive 3D BVF
Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.
Device: nanOss Bioactive 3D BVF
nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed.

Primary Outcome Measures :
  1. Number of Patients With Fusion [ Time Frame: 12 months ]
    Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.

Secondary Outcome Measures :
  1. Number of Participants With Improvement in Quality of Life [ Time Frame: 12 months ]
    Number of participants with improvement in quality of life after surgery using the RAND-36 (a short form health survey). It is a 36 set of easily administered quality of life measures answered by the patient.

  2. Number of Participants With Improvement in Pain Scores [ Time Frame: 12 months ]
    Number of participants with improvement in pain scores after surgery using the Visual Analog Scale. The scale measured from (0) no pain to (10) unbearable pain.

  3. Number of Participants With Decreased Usage of Pain Medication [ Time Frame: 12 months ]
    Number of participants with decreased usage of pain medication after surgery

  4. Returning to Work [ Time Frame: 12 Months ]
    Time frame in which patient returned to work after surgery

  5. Satisfaction With Surgery [ Time Frame: 12 months ]
    Overall satisfaction with the procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 21 years of age and skeletally mature.
  • Symptomatic spinal stenosis secondary to DDD with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1 requiring instrumented PLF surgery.
  • Completed a minimum of 6 months of non-operative treatment.
  • Pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (AP, Lateral, Flexion and Extension images and an MRI or CT scan).
  • Is willing and able to return for post-treatment exams according to the follow-up called for in the protocol.
  • Is able to review, understand and sign the informed consent document.

Exclusion Criteria:

  • Symptomatic at more than two levels.
  • Has had previous fusion surgery at the level(s) to be treated (previous discectomy, laminotomy, laminectomy or nucleolysis at the level(s) to be treated < 6 months ago is ok).
  • Has > 11 degrees lumbar scoliosis.
  • Has > 40 BMI.
  • Has > Grade 1 spondylolisthesis.
  • Has osteoporosis (T-score of -2.5 or below), osteomalacia, Paget's disease or metabolic bone disease.
  • Has a disease that significantly inhibits bone healing (e.g., diabetes type 1, renal failure, impaired calcium metabolism).
  • Has a medical condition that requires or has a history of chronic steroid use (i.e., oral steroids), with the exception of inhaled/nasal corticosteroids steroids or has any medical condition that requires treatment with drugs known to interfere with bone healing.
  • Has a neurological disease (e.g., Parkinson's disease), a psychosocial disorder (e.g., suicidal, diminished capacity) or has a history of substance abuse which would preclude accurate evaluation or limit the ability to comply with study requirements.
  • Has either an active infection or infection at the site of surgery
  • Has a systemic disease (e.g., AIDS, HIV, active hepatitis, tuberculosis)
  • Has rheumatoid arthritis or other autoimmune disease.
  • Has spinal tumors.
  • Has an active malignancy (except non-melanoma skin cancer) or history of any invasive malignancy unless treated and in remission for at least five years.
  • Has a known sensitivity or allergies to porcine collagen, PEEK, tantalum or titanium.
  • Has active arachnoiditis.
  • Has fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
  • Is a prisoner.
  • Is involved in spinal litigation at the treated level(s).
  • Is participating in another clinical study that would confound Study data.
  • Is pregnant or is interested in becoming pregnant while participating in the Study.

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 identifier (NCT number): NCT01829997

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United States, New York
Hospital for Joint Disease
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
United States, South Carolina
MUSC Neurosurgery & Spine Services
Charleston, South Carolina, United States, 29425
United States, Wisconsin
Milwaukee Spinal Specialists
Glendale, Wisconsin, United States, 53212
Sponsors and Collaborators
Pioneer Surgical Technology, Inc.
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Principal Investigator: Stephen Robbins, MD Milwaukee Spinal Specialists
  Study Documents (Full-Text)

Documents provided by Pioneer Surgical Technology, Inc.:
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Responsible Party: Pioneer Surgical Technology, Inc. Identifier: NCT01829997    
Other Study ID Numbers: NB3D012012
First Posted: April 11, 2013    Key Record Dates
Results First Posted: April 17, 2019
Last Update Posted: April 17, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases