Back to resultsOsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Primary Purpose
Degenerative Changes, Stenosis, Spondylosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterolateral Fusion
Sponsored by
About this trial
This is an interventional other trial for Degenerative Changes
Eligibility Criteria
Inclusion Criteria:
- Are 18 (eighteen) years of age or older at the time of surgery.
- 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.
- 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.
- Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
- Are willing and able to sign study specific informed consent.
Exclusion Criteria:
- 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.
- 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.
- Are being treated with radiotherapy.
- 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).
- Are pregnant, lactating or women wishing to become pregnant.
- Are a prisoner.
- BMI ≥ 40
- Are smokers and/or nicotine/tobacco users
- 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.
- 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.
- 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).
Sites / Locations
- Sherban Orthopaedic and Spine Surgery, PLLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OsteoStrux Collagen Ceramic Scaffold
Local autograft
Arm Description
OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side)
Local autograft (posterolateral gutter at the contralateral side)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score.
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan
Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point.
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.
The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable."
The study in this scale is used for the worst leg pain. A lower score represents a better score.
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable."
The study in this scale is used for back pain. A lower score represents a better score.
Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.
Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral posterolateral spinal side is local autograft.
NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01873586
Brief Title
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Official Title
Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeaSpine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Changes, Stenosis, Spondylosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OsteoStrux Collagen Ceramic Scaffold
Arm Type
Experimental
Arm Description
OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side)
Arm Title
Local autograft
Arm Type
Active Comparator
Arm Description
Local autograft (posterolateral gutter at the contralateral side)
Intervention Type
Procedure
Intervention Name(s)
Posterolateral Fusion
Primary Outcome Measure Information:
Title
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
Description
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 Outcome Measure Information:
Title
Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT
Description
Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan.
Time Frame
12 months
Title
Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months
Description
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
Title
Interbody Fusion as Determined by CT Post-surgery at Available Time-points
Description
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.
Time Frame
12 months
Title
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points
Description
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score.
Time Frame
upto 24 months
Title
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan
Description
Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point.
Time Frame
12 months
Title
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.
Description
The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.
Time Frame
upto 24 months
Title
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.
Description
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable."
The study in this scale is used for the worst leg pain. A lower score represents a better score.
Time Frame
upto 24 months
Title
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.
Description
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable."
The study in this scale is used for back pain. A lower score represents a better score.
Time Frame
upto 24 months
Title
Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.
Description
Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral posterolateral spinal side is local autograft.
NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable.
Time Frame
upto 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are 18 (eighteen) years of age or older at the time of surgery.
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.
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.
Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
Are willing and able to sign study specific informed consent.
Exclusion Criteria:
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.
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.
Are being treated with radiotherapy.
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).
Are pregnant, lactating or women wishing to become pregnant.
Are a prisoner.
BMI ≥ 40
Are smokers and/or nicotine/tobacco users
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.
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.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Sherban, DO
Organizational Affiliation
Sherban Orthopaedic and Spine Surgery, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherban Orthopaedic and Spine Surgery, PLLC
City
Kenmore
State/Province
New York
ZIP/Postal Code
14217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
We'll reach out to this number within 24 hrs