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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsteoStrux Collagen Ceramic Scaffold | Experimental | OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side) |
|
| Local autograft | Active Comparator | Local autograft (posterolateral gutter at the contralateral side) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterolateral Fusion | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross Sherban, DO | Sherban Orthopaedic and Spine Surgery, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sherban Orthopaedic and Spine Surgery, PLLC | Kenmore | New York | 14217 | United States |
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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).
| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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). | Posted | Count of Units | Posterolateral Gutters | up to 24 months | Posterolateral Gutters | Posterolateral Gutters |
|
Up to 24 months
Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | 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). Adverse events are unable to be distinguished per posterolateral gutter or spinal level and therefore results are submitted on a per patient basis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bilateral hip replacement | Surgical and medical procedures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small Durotomy/Dural Tear | Surgical and medical procedures |
The following outcomes were unable to be analyzed due to the limitations of the protocol and analysis design and the inability to distinguish differences in posterolateral gutter analysis; neurological function and interbody fusion assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Affairs | SeaSpine | tish.mikoczi@seaspine.com |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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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. |
| 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. | 12 months |
| 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. | upto 24 months |
| 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. | 12 months |
| 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. | upto 24 months |
| 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. | upto 24 months |
| 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. | upto 24 months |
| 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. | upto 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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 | 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. | 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). | Posted | Count of Units | Posterolateral gutters | 12 months | Posterolateral gutters | Posterolateral gutters |
|
|
|
| Secondary | 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. | NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed. | Posted | No | upto 24 months |
|
|
| Secondary | 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. | NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed. | Posted | 12 months |
|
|
| Secondary | 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. | Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side". | Posted | Mean | Standard Deviation | units on a scale | upto 24 months |
|
|
|
| Secondary | 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. | Posted | Count of Units | Posterolateral Gutters | 12 months | Posterolateral Gutters | Posterolateral Gutters |
|
|
|
| Secondary | 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. | Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side". | Posted | Mean | Standard Deviation | units on a scale | upto 24 months |
|
|
|
| Secondary | 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. | Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side". | Posted | Mean | Standard Deviation | units on a scale | upto 24 months |
|
|
|
| Secondary | 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. | Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side". | Posted | Mean | Standard Deviation | units on a scale | upto 24 months |
|
|
|
| Secondary | 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. | 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. | Posted | upto 24 months |
|
|
| 0 |
| 29 |
| 5 |
| 29 |
| 3 |
| 29 |
| renal insufficiency | Endocrine disorders |
|
| hip infection after hip replacement | Infections and infestations |
|
| cage migration secondary to poor bone quality which required revision | Surgical and medical procedures |
|
| one episode of increased pain in low back and both legs which required hospitalization w/out surgery | Musculoskeletal and connective tissue disorders |
|
| one episode of self-admittance to hospital for 8 days to detox from medication | Social circumstances |
|
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| D009140 | Musculoskeletal Diseases |
|
| 12 Months |
|
|
| 24 Months |
|
|
| Title | Measurements |
|---|---|
|
| Local Autograft (contralateral): Disagree |
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| Title | Measurements |
|---|---|
|
| 24 Months |
|
| Title | Measurements |
|---|---|
|
| 24 Months |
|