OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

SeaSpine, Inc.29 enrolled

Overview

The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Degenerative Changes Stenosis Spondylosis

Interventions

Posterolateral FusionPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Are 18 (eighteen) years of age or older at the time of surgery. 2. Require spinal fusion using TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1. 3. Are willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 3 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months. 4. Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention. 5. Are willing and able to sign study specific informed consent. Exclusion Criteria: 1. Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled steroids are allowed), or epidural steroid injections. 2. Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery. 3. Are being treated with radiotherapy. 4. Are having medical conditions, known to impact bone metabolism, such as Paget's disease, or has established osteoporosis (i.e. has had one or more fragility fractures). 5. Are pregnant, lactating or women wishing to become pregnant. 6. Are a prisoner. 7. BMI ≥ 40 8. Are smokers and/or nicotine/tobacco users 9. Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. 10. Had prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures. 11. Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).

Locations (1)

Sherban Orthopaedic and Spine Surgery, PLLC

Kenmore, New York, United States

Outcomes

Primary Outcomes

Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.

Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

Time frame: up to 24 months

Secondary Outcomes

Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT

Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan.

Time frame: 12 months

Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months

NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was indistinguishable per arms, data were not collected due to a limitation in the method of analysis per protocol. Therefore data was not analyzed and outcome is NA.

Time frame: upto 24 months

Interbody Fusion as Determined by CT Post-surgery at Available Time-points

NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.

Data from ClinicalTrials.gov

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