Assessment of nanOss Bioactive 3D in the Posterolateral Spine

NCT01829997 | Completed Results

• 1 other identifier: NB3D012012
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

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.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants With Improvement in Quality of Life

  12 months

• Number of Participants With Improvement in Pain Scores

  12 months

• Number of Participants With Decreased Usage of Pain Medication

  12 months

• Returning to Work

  12 Months

• Satisfaction With Surgery

  12 months

Study Arms (1)

nanOss Bioactive 3D BVF

EXPERIMENTAL

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

Interventions

nanOss Bioactive 3D BVF 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.

nanOss Bioactive 3D BVF

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pioneer Surgical Technology, Inc.: lead

Study Sites (4)

Hospital for Joint Disease

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MUSC Neurosurgery & Spine Services

Charleston, South Carolina, 29425, United States

Location

Milwaukee Spinal Specialists

Glendale, Wisconsin, 53212, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Results Point of Contact

• Title: Kristina Shine
• Organization: RTI Surgical

kshine@rtix.com

386-418-8888

Study Officials

• Stephen Robbins, MD

  Milwaukee Spinal Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 17, 2019
• Results First Posted: April 17, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)