Spinal Stenosis
Conditions
Brief summary
To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.
Detailed description
The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of moderate to severe lumbar spinal stenosis. The device is specifically designed to provide stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two levels in the region of L1 - L5. The height of the neuroforamen is maintained and the facet joints will be relieved. By this a further destruction is prevented. Unlike conventional stabilization methods as for example spinal fusion, the function of the segment will be maintained and adjacent structures will be effectively protected. Possible risks, which could occur after implantation of the coflex® Interlaminar Technology are breakage of the implant, displacement of the implant, pain which is caused by the implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that first-time retrospective data is raised for potential improvement regarding therapy of lumbar back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an improvement of the therapy. In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for patients treated with the coflex® Interlaminar Technology during normal conditions of use. This data will provide evidence to support publications and marketing.
Interventions
Interlaminer Technology
Sponsors
MCRA
Paradigm Spine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must meet the criteria specified in the device labeling including radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from L1-L5 that require surgical decompression.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology | Study Duration Up to 6 months for data collection | To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression. |
| Overall Incidence of Secondary Surgical Interventions Post Surgeries. | Study Duration up to 6 months data | To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits. | Study Duration Up to 6 months for data collection | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decompression Standard of care decompression for spinal stenosis, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology | 1,486 |
| Fusion Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology | 1,009 |
| Coflex® Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
coflex® Interlaminar Technology: Interlaminer Technology | 2,299 |
| Hybrid coflex and fusion at adjacent levels | 256 |
| Total | 5,050 |
Baseline characteristics
| Characteristic | Decompression | Fusion | Coflex® | Hybrid | Total |
|---|---|---|---|---|---|
| Age, Customized Age | 61.9 years STANDARD_DEVIATION 15.46 | 65.4 years STANDARD_DEVIATION 11.54 | 68.1 years STANDARD_DEVIATION 9.96 | 65.8 years STANDARD_DEVIATION 10.34 | 65.6 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 93 Participants | 21 Participants | 40 Participants | 8 Participants | 162 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 564 Participants | 196 Participants | 539 Participants | 25 Participants | 1324 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 829 Participants | 792 Participants | 1720 Participants | 223 Participants | 3564 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 4 Participants | 1 Participants | 5 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 4 Participants | 6 Participants | 0 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Black or African American | 80 Participants | 36 Participants | 81 Participants | 14 Participants | 211 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Not Specified | 607 Participants | 717 Participants | 1198 Participants | 189 Participants | 2711 Participants |
| Race/Ethnicity, Customized Race White | 789 Participants | 251 Participants | 1009 Participants | 53 Participants | 2102 Participants |
| Sex/Gender, Customized Female | 629 Participants | 607 Participants | 1040 Participants | 119 Participants | 2395 Participants |
| Sex/Gender, Customized Male | 856 Participants | 402 Participants | 1257 Participants | 137 Participants | 2652 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology
To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.
Time frame: Study Duration Up to 6 months for data collection
Population: The following arms: coflex® and Decompression, were the only arms where this data was collected and compared for this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coflex® | 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 |
| Decompression | Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology | 191.75 days | Standard Deviation 247.23 |
Primary
Overall Incidence of Secondary Surgical Interventions Post Surgeries.
To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.
Time frame: Study Duration up to 6 months data
Population: The following arms: coflex® , Fusion, and Decompression, were the only arms where this data was collected and compared for this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coflex® | Overall Incidence of Secondary Surgical Interventions Post Surgeries. | 126 Participants |
| Decompression | Overall Incidence of Secondary Surgical Interventions Post Surgeries. | 125 Participants |
| Fusion | Overall Incidence of Secondary Surgical Interventions Post Surgeries. | 99 Participants |
Secondary
The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.
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.
Time frame: Study Duration Up to 6 months for data collection
Population: The data (clinical, radiologic, and PROs) was not collected from the sites.