Assessment of nanOss Bioactive 3D in the Posterolateral Spine

NCT ID: NCT01829997

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-04-30

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.

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.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

nanOss Bioactive 3D BVF

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pioneer Surgical Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Robbins, MD

Role: PRINCIPAL_INVESTIGATOR

Milwaukee Spinal Specialists

Locations

Hospital for Joint Disease

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

MUSC Neurosurgery & Spine Services

Charleston, South Carolina, United States

Milwaukee Spinal Specialists

Glendale, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NB3D012012

Identifier Type: -

Identifier Source: org_study_id