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The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort. The historical patient cohort has not been previously published and therefore, no reference to this group can be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Demineralized Bone Matrix | Other | a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space |
|
| rh-BMP2 | Other | A retrospective cohort of patients who were age- and sex- matched to the prospective cohort who underwent posterolateral lumbar fusion with use of rh-BMP2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demineralized Bone Matrix | Device | Accell Evo3 in posteriolateral fusion (prospective cohort) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery | Posterolateral fusion by radiographic assessment 12 months post surgery | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Klineberg, M.D. | University of CA - Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery | Sacramento | California | 95816 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | OsteoSurg 300 | Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space. |
| FG001 | rhBMP-2 | Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OsteoSurg 300 | Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery | Posterolateral fusion by radiographic assessment 12 months post surgery | One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments. | Posted | Count of Units | radiographic assessments | 12 months | radiographic assessments | radiographic assessments |
|
24 months
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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 | OsteoSurg 300 | Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Orthobiologics Research & Development | SeaSpine | 760.216.5138 | frank.vizesi@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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| rh-BMP2 | Device | rh-BMP2 in posterolateral fusion (retrospective cohort) |
|
|
| rhBMP-2 |
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| rhBMP-2 |
Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space. |
|
|
| 0 |
| 16 |
| 5 |
| 16 |
| 9 |
| 16 |
| EG001 | rhBMP-2 | Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space. | 0 | 21 | 3 | 21 | 15 | 21 |
| Loss of sensory and/or motor function | Nervous system disorders | Systematic Assessment | decreased sensation in the right lower extremity compared to the left |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Neurologic deficit | Nervous system disorders | Systematic Assessment |
|
| Unresolved pain | Nervous system disorders | Systematic Assessment | Patient presents with worsening back pain and new onset radicular symptoms into her right thigh. Also complains of fecal incontinence |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory issues | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Patient reported 2 days of vomiting and pain radiating from her abdomen to her back. She was diagnosed with symptomatic small bowel volvulus |
|
| Fractured Toe | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dural Tear | Nervous system disorders | Systematic Assessment |
|
| Gait disturbance | Nervous system disorders | Systematic Assessment |
|
| Loss of sensory and/or motor function | Nervous system disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Numbness/Tingling | Nervous system disorders | Systematic Assessment |
|
| Unresolved Pain | Nervous system disorders | Systematic Assessment |
|
| Swelling | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombosis | Cardiac disorders | Systematic Assessment |
|
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| D009140 | Musculoskeletal Diseases |