Assessment of nanOss Bioactive 3D in the Posterolateral Spine

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Pioneer Surgical Technology, Inc.
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier:
NCT01829997
First received: April 8, 2013
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention
Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Device: nanOss Bioactive 3D BVF

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Post-Market Assessment Of NanOss Bioactive 3D in the Posterolateral Spine

Resource links provided by NLM:


Further study details as provided by Pioneer Surgical Technology, Inc.:

Primary Outcome Measures:
  • Number of patients with fusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Number of participants with improvement in physical disability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of participants with improvement in quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of participants with improvement in pain scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of participants with decreased usage of pain medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Returning to work [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Satisfaction with surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829997

Contacts
Contact: Margot MacDonald-Berko 906-225-5860 margotberko@pioneersurgical.com
Contact: Melinda Wooten 252-353-8204 melindawooten@pioneersurgical.com

Locations
United States, South Carolina
MUSC Neurosurgery & Spine Services Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Abhay K Varma, MD         
United States, Wisconsin
Milwaukee Spinal Specialists Recruiting
Glendale, Wisconsin, United States, 53212
Principal Investigator: Stephen Robbins, MD         
Sponsors and Collaborators
Pioneer Surgical Technology, Inc.
Investigators
Principal Investigator: Stephen Robbins, MD Milwaukee Spinal Specialists
  More Information

No publications provided

Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT01829997     History of Changes
Other Study ID Numbers: NB3D012012
Study First Received: April 8, 2013
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Stenosis
Spondylolisthesis
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on July 29, 2014