Study to Investigate the Long Term Survivorship of Coflex CT Study: Sub-Analysis of 24 Month Spinous Process Fractures Via Post-60 Month CT Scan
Phase: NA
Conditions: Spinal Fractures
Sponsor: Paradigm Spine

 
 
 
coflex® CT Study 
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STUDY TO INVESTIGATE THE LONG TERM SURVIVORSHIP OF COFLEX  
CT Study: Sub-Analysis of 24 Month Spinous Process Fractures via Post-60 Month CT Scan 
 
1. Objective 
The primary objective of this study is 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.  
 
The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two 
level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in 
function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without 
back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended 
to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. 
Interlaminar stabilization is performed after decompression of stenosis at the affected level(s). 
 
2. Study Design 
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 the site and/or 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 time point.  
 
3. Study Population 
The study population consists of all living subjects who participated in the coflex® IDE Study and had a 
spinous process fractures at 24 months. The spinous process fractures include those identified by the site 
and/or those identified by the independent radiographic review lab (via X-ray or CT). The following 17 
subjects presented with a spinous process fracture at 24 months, and will be reviewed based on the exclusion 
criteria. Those patients available for enrollment will be asked to return for a CT Scan: 
Site 05 
05-114 
05-202 
05-206 
05-229 
 
Site 06 
06-104 
06-219 
 
 
 
Site 07 
07-204 
 
 
 
 
Site 15 
15-217 
 
 
 
 
Site 17 
17-120 
17-207 
 
 
 
Site 19 
19-110 
19-119 
19-209 
19-210 
19-211 
Site 23 
23-204 
 
 
 
 
Site 32 
32-112 
 
 
 
 
 

 
 
 
coflex® CT Study 
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Since the subjects have already been screened as part of the IDE Study, and only patients that participated 
in that study make up the patient cohort for this CT Study population, the only inclusion criteria necessary 
for this study are: 
1. Participant in coflex® IDE Study  
2. Willing and able to give informed consent 
3. Spinous process fracture identified by site and/or radiographic lab at 24 months 
Exclusion criteria for the study are as follows: 
1. Subjects who died, were withdrawn or withdrew consent to participate in the study 
2. Subjects who are pregnant, or planning to become pregnant, during the course of this study 
3. Subjects who have cancer, whether active or in remission. 
 
4. Subject Recruitment 
Each site will be responsible for contacting those patients that participated in the IDE Study and consent 
them for the current CT Study. Each patient will be asked to return for a CT Scan. To encourage enrollment 
in the study, each patient will receive a $500 gift card upon completion of the CT Scan to cover the cost of 
time, travel and expenses. 
 
5. Study Procedures 
Patients will have undergone placement of the coflex® Interlaminar Stabilization Device as part of the IDE 
study.  
The only procedure performed as part of the CT Study is a CT Scan of the lumbar spine at least 5 years 
post-implantation of the coflex® device. 
The scans will be sent to the independent radiographic review lab for analysis. 
 
6. Risks 
There are risks associated with CT Scan. The subject will be exposed to a small amount of radiation 
called "ionizing radiation".  Studies have shown that getting a lot of radiation at one time or getting 
many small doses over time may cause cancer.  The risk of getting cancer from the one small 
radiation dose in this study is very small. 
 
The standard effective dose for a lumbar spine CT Scan is 1.5 mSv, which is equivalent to 75 chest 
x-rays. All patients will have 1 CT Scan. 
 

 
 
 
coflex® CT Study 
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7. Informed Consent 
All patients will be consented prior to enrollment in the CT Study. The informed consent will clearly 
identify the procedures to be performed (i.e., CT Scan), the costs subject to payment by the participant, and 
compensation for participation. 
 
8. Study Data 
The data will be submitted to the Food and Drug Administration (FDA) to support the long-term safety and 
effectiveness of the coflex® Interlaminar Stabilization device.