Trial Outcomes & Findings for Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion (NCT NCT03041896)
NCT ID: NCT03041896
Last Updated: 2020-05-19
Results Overview
To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.
COMPLETED
5050 participants
Study Duration Up to 6 months for data collection
2020-05-19
Participant Flow
Participant milestones
| Measure |
Decompression
Standard of care decompression for spinal stenosis, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Fusion
Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Coflex®
Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Hybrid
coflex and fusion at adjacent levels
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1486
|
1009
|
2299
|
256
|
|
Overall Study
COMPLETED
|
1486
|
1009
|
2236
|
253
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
63
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
Baseline characteristics by cohort
| Measure |
Decompression
n=1486 Participants
Standard of care decompression for spinal stenosis, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Fusion
n=1009 Participants
Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Coflex®
n=2299 Participants
Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Hybrid
n=256 Participants
coflex and fusion at adjacent levels
|
Total
n=5050 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
61.9 years
STANDARD_DEVIATION 15.46 • n=99 Participants
|
65.4 years
STANDARD_DEVIATION 11.54 • n=107 Participants
|
68.1 years
STANDARD_DEVIATION 9.96 • n=206 Participants
|
65.8 years
STANDARD_DEVIATION 10.34 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 12.5 • n=31 Participants
|
|
Sex/Gender, Customized
Male
|
856 Participants
n=99 Participants
|
402 Participants
n=107 Participants
|
1257 Participants
n=206 Participants
|
137 Participants
n=7 Participants
|
2652 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Female
|
629 Participants
n=99 Participants
|
607 Participants
n=107 Participants
|
1040 Participants
n=206 Participants
|
119 Participants
n=7 Participants
|
2395 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
162 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
564 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
539 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
1324 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
829 Participants
n=99 Participants
|
792 Participants
n=107 Participants
|
1720 Participants
n=206 Participants
|
223 Participants
n=7 Participants
|
3564 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
80 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
211 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
789 Participants
n=99 Participants
|
251 Participants
n=107 Participants
|
1009 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
2102 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Not Specified
|
607 Participants
n=99 Participants
|
717 Participants
n=107 Participants
|
1198 Participants
n=206 Participants
|
189 Participants
n=7 Participants
|
2711 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Study Duration Up to 6 months for data collectionPopulation: The following arms: coflex® and Decompression, were the only arms where this data was collected and compared for this study.
To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.
Outcome measures
| Measure |
Coflex®
n=2058 Participants
Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Decompression
n=1428 Participants
Standard of care decompression for spinal stenosis, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Fusion
Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
|
Hybrid
coflex and fusion at adjacent levels
coflex® Interlaminar Technology: Interlaminer Technology
|
|---|---|---|---|---|
|
Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology
|
201.26 days
Standard Deviation 208.64
|
191.75 days
Standard Deviation 247.23
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Duration up to 6 months dataPopulation: The following arms: coflex® , Fusion, and Decompression, were the only arms where this data was collected and compared for this study.
To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.
Outcome measures
| Measure |
Coflex®
n=1428 Participants
Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Decompression
n=2058 Participants
Standard of care decompression for spinal stenosis, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology
|
Fusion
n=1009 Participants
Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
|
Hybrid
coflex and fusion at adjacent levels
coflex® Interlaminar Technology: Interlaminer Technology
|
|---|---|---|---|---|
|
Overall Incidence of Secondary Surgical Interventions Post Surgeries.
|
126 Participants
|
125 Participants
|
99 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Duration Up to 6 months for data collectionPopulation: The data (clinical, radiologic, and PROs) was not collected from the sites.
To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device. The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.
Outcome measures
Outcome data not reported
Adverse Events
Decompression
Fusion
Coflex®
Hybrid
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
Restriction type: GT60