Assessment of nanOss Bioactive 3D in the Posterolateral Spine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis

Intervention / Treatment
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* Device: nanOss Bioactive 3D BVF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nanOss Bioactive 3D BVF<br>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<br>* 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.<br>|

What is the study measuring?
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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 |