Trial Outcomes & Findings for Study to Investigate the Long Term Survivorship of Coflex (NCT NCT02918669)
NCT ID: NCT02918669
Last Updated: 2020-02-24
Results Overview
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.
COMPLETED
NA
12 participants
Post-60 Months
2020-02-24
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Long Term Survivorship of Coflex
Baseline characteristics by cohort
| Measure |
Coflex
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
CT Scan of the coflex® in patients who presented with spinous process fractures at 24 months
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-60 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Coflex
n=8 Participants
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.
|
|---|---|
|
Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan
|
8 Participants
|
POST_HOC outcome
Timeframe: >/= 5 years0 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
Outcome measures
| Measure |
Coflex
n=8 Participants
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.
|
|---|---|
|
Fracture Location
Anterior to wings
|
6 fractures
|
|
Fracture Location
Coincident with implant wings
|
2 fractures
|
POST_HOC outcome
Timeframe: >/= 5 years0 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
Outcome measures
| Measure |
Coflex
n=8 Participants
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.
|
|---|---|
|
Fracture Displacement
Displaced
|
5 fractures
|
|
Fracture Displacement
Non-Displaced
|
6 fractures
|
POST_HOC outcome
Timeframe: >/= 5 years0 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
Outcome measures
| Measure |
Coflex
n=8 Participants
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.
|
|---|---|
|
Fracture Healing
Healed
|
4 fractures
|
|
Fracture Healing
Remodeled
|
3 fractures
|
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Fracture Healing
Not Healed
|
2 fractures
|
|
Fracture Healing
Indeterminate
|
2 fractures
|
Adverse Events
Coflex
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place