Kyphosis, Neurologic Deficits, Pseudarthrosis, Spondylolisthesis
Conditions
Keywords
Spondylolisthesis, Neurologic impairment, Kyphosis, Pseudarthrosis
Brief summary
The purpose of the Post-Market Surveillance study is to evaluate safety.
Detailed description
Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.
Interventions
DEVICEDynamic Stabilization System (DSS)
Dynamic Stabilization System
Sponsors
MCRA
Paradigm Spine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient is skeletally mature (21-85 years old). * Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level. * Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations. * Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.
Exclusion criteria
* The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications. * Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general. * Acute or chronic systemic, spinal or localized infections. * Active, severe systemic and metabolic diseases. * Obesity defined as Body Mass Index \> 35. * Subject is pregnant or interested in becoming pregnant in the next 36 months. * Dependency on pharmaceutical drugs, drug abuse, or alcoholism. * Lack of patient cooperation. * Foreign body sensitivity to the implant material. * Degenerative scoliosis greater than 25 degrees. * Grade 4 degenerative spondylolisthesis (\>75% slip). * Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required\*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia). * Soft tissue deficit not allowing wound closure. * Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device. * Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae. * Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication. * Pars defect. * Clinically compromised vertebral bodies at affected level due to current or past trauma. * Prisoner or ward of the state. * Currently in litigation regarding a spinal condition. * Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents. * Is currently involved in a study of another investigational product for similar purpose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure. | 6 months | The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI). | 6 months | ODI is a questionnaire that provides information on back and the affects on managing every day life by diving questions into 10 sections. The total possible score for each section is 0-5. The scores are then converted into percentages ranging from 0% (minimal disability) to 100% (maximum possible disability). |
| Measurement of Lower Back Pain as Assessed by Visual Analog Scale | 6 months | Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain) |
| Measurement of Right Leg Pain as Assessed by Visual Analog Scale | 6 months | Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain) |
| Measurement of Left Leg Pain as Assessed by Visual Analog Scale | 6 months | Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain) |
| Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline. | Pre-Op, 6 weeks, 6 months, 12 months, and 24 months | The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 worst imaginable health state to 100 best imaginable health state. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSS Stabilization System DSS Stabilization System | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | FDA reclassified Dynamic Stabilization D | 1 |
Baseline characteristics
| Characteristic | DSS Stabilization System |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dynamic Stabilization System | Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure. | 0 Participants |
Secondary
Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).
ODI is a questionnaire that provides information on back and the affects on managing every day life by diving questions into 10 sections. The total possible score for each section is 0-5. The scores are then converted into percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dynamic Stabilization System | Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI). | 2 score on a scale |
Secondary
Measurement of Left Leg Pain as Assessed by Visual Analog Scale
Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dynamic Stabilization System | Measurement of Left Leg Pain as Assessed by Visual Analog Scale | 12 units on a scale |
Secondary
Measurement of Lower Back Pain as Assessed by Visual Analog Scale
Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dynamic Stabilization System | Measurement of Lower Back Pain as Assessed by Visual Analog Scale | 2 units on a scale |
Secondary
Measurement of Right Leg Pain as Assessed by Visual Analog Scale
Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dynamic Stabilization System | Measurement of Right Leg Pain as Assessed by Visual Analog Scale | 2 units on a scale |
Secondary
Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline.
The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 worst imaginable health state to 100 best imaginable health state.
Time frame: Pre-Op, 6 weeks, 6 months, 12 months, and 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dynamic Stabilization System | Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline. | 1 participants |