Spinal Fractures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONCT 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.
Sponsors
Paradigm Spine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant in coflex IDE Study * Willing and able to give informed consent * Spinous process fracture identified by site and/or radiographic lab at 24 months
Exclusion criteria
* Subjects who died, were withdrawn or withdrew consent to participate in the study * Subjects who are pregnant, or planning to become pregnant, during the course of this study * Subjects who have cancer, whether active or in remission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan | Post-60 Months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Coflex |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| CT Scan of the coflex® in patients who presented with spinous process fractures at 24 months | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Post-60 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coflex | Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan | 8 Participants |
Post Hoc
Fracture Displacement
0 N/A; no spinous process fracture reported 1. Non-displaced; no evidence of a displaced spinous process fracture 2. Displaced; presence of a displaced spinous process fracture. No contact between the fragment and the remaining vertebra should exist, and at least 2 mm wide gap should exist at a point along the fracture gap 3. Indeterminate; assessment cannot be made due to technical factors such as obscured anatomy due to the device wings, poor contrast, high parallax or significant artifacts that result in images being of non-diagnostic quality
Time frame: >/= 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coflex | Fracture Displacement | Displaced | 5 fractures |
| Coflex | Fracture Displacement | Non-Displaced | 6 fractures |
Post Hoc
Fracture Healing
0 N/A; no spinous process fracture reported 1. Not healed; no evidence of a spinous process fracture healing 2. Healed; presence of a healed spinous process fracture 3. Remodeled; fracture line is absent due to bone remodeling at the site of a previously detected fracture 4. Indeterminate - no follow-up imaging available; no images are available at time points later than the time point when the fracture was identified 5. Indeterminate - inadequate image quality; the quality of available images is inadequate to determine the fracture healing status 6. Indeterminate - implant obscures fracture; the coflex implant obscures visualization of the fracture line so healing cannot be determined
Time frame: >/= 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coflex | Fracture Healing | Healed | 4 fractures |
| Coflex | Fracture Healing | Remodeled | 3 fractures |
| Coflex | Fracture Healing | Not Healed | 2 fractures |
| Coflex | Fracture Healing | Indeterminate | 2 fractures |
Post Hoc
Fracture Location
0 None; no evidence of spinous process fracture 1. Posterior avulsion; presence of a fracture pattern consistent with lumbar spinous process avulsion fractures 2. Posterior to implant wings; presence of a spinous process fracture posterior 3. Coincident with implant wings: presence of a spinous process fracture in the same coronal plane as the implant wings 4. Anterior to implant wings; presence of a spinous process fracture anterior to the implant wings 5. Indeterminate; assessment cannot be made due to technical factors such as obscured anatomy due to the device wings, poor contrast, high parallax or significant artifacts that result in images being of non-diagnostic quality
Time frame: >/= 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coflex | Fracture Location | Anterior to wings | 6 fractures |
| Coflex | Fracture Location | Coincident with implant wings | 2 fractures |