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Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using X-ray or CT). All patients were enrolled and followed through 60 months under the IDE and extended follow-up protocol.
The specific objective of this CT Study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coflex | Experimental | Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Scan | Radiation | Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months. There are no other interventions. It is just a onetime CT post 60 month time point. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan | Any coflex patients with radiographic observations of spinous process fracture at post-24 months, will be examined via CT at 5 years for evidence of fracture or of healing. | Post-60 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hal Mathews, MD | Paradigm Spine | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coflex | Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan. CT Scan: Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months. There are no other interventions. It is just a onetime CT post 60 month time point. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who presented with spinous process fractures at 24 months in the Paradigm Spine coflex® IDE Study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Coflex | Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan. CT Scan: Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months. There are no other interventions. It is just a onetime CT post 60 month time point. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan | Any coflex patients with radiographic observations of spinous process fracture at post-24 months, will be examined via CT at 5 years for evidence of fracture or of healing. | To examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fractures at 24 months in the Paradigm Spine coflex IDE Study. | Posted | Count of Participants | Participants | Post-60 Months |
|
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Adverse events were not monitored/assessed as part of this study. The only data collected was the CT scan which was reviewed by an independent radiographic lab.
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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 | Coflex | Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months. There are no other interventions. It is just a onetime CT post 60 month time point. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fran Magee, DVM | Paradigm Spine | 212-367-7274 | fran.magee@paradigmspine.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 2, 2016 | Oct 9, 2018 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 20, 2016 | Oct 9, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| CT Scan of the coflex® in patients who presented with spinous process fractures at 24 months | Count of Participants | Participants |
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| Post-Hoc | Fracture Location | 0 None; no evidence of spinous process fracture
| Posted | Number | fractures | >/= 5 years |
|
|
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| Post-Hoc | Fracture Displacement | 0 N/A; no spinous process fracture reported
| Posted | Number | fractures | >/= 5 years |
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| Post-Hoc | Fracture Healing | 0 N/A; no spinous process fracture reported
| Posted | Number | fractures | >/= 5 years |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Title | Measurements |
|---|
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| Indeterminate |
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