Assessment of nanOss Bioactive 3D in the Posterolateral Spine

A Prospective, Post-Market Assessment Of NanOss Bioactive 3D in the Posterolateral Spine

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis
• Intervention / Treatment: Device: nanOss Bioactive 3D BVF

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • New York, New York, United States, 10003
      • Hospital for Joint Disease
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Neurosurgery & Spine Services
  • Wisconsin
    • Glendale, Wisconsin, United States, 53212
      • Milwaukee Spinal Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Fusion	Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improvement in Quality of Life	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.	12 months
Number of Participants With Improvement in Pain Scores	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.	12 months
Number of Participants With Decreased Usage of Pain Medication	Number of participants with decreased usage of pain medication after surgery	12 months
Returning to Work	Time frame in which patient returned to work after surgery	12 Months
Satisfaction With Surgery	Overall satisfaction with the procedure	12 months

Collaborators and Investigators

• Sponsor: Pioneer Surgical Technology, Inc.
• Investigators: Principal Investigator: Stephen Robbins, MD, Milwaukee Spinal Specialists

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: NB3D012012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO