The purpose of this study is to assess the safety and effectiveness of the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain secondary to failed back surgery syndrome (FBSS) over a follow-up period of one…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes
1. Percentage of pain relief experienced in the area of pain identified at
baseline compared to 12 months post full implant of the Freedom SCS system.
2. Incidence and severity of device related adverse events during the study,
for example:
a. Biological response to the implant procedure requiring treatment (e.g.,
hematoma, dural puncture, skin erosion or infection, allergic reaction)
b. Technical failure of the electrode (e.g., electrode failure, fracture, or
migration/malposition requiring removal/replacement)
c. Technical failure of the external pulse generator (e.g., power level
variations, over/under/intermittent /uncomfortable stimulation, unacceptable
postural effects, device interaction with external stimulus). (Note:
programming changes to increase paresthesia coverage to capture areas of new
pain are not adverse events.)
Secondary outcome
Secondary outcomes
1. To assess compliance data to indicate usability:
o How many hours/day does the patient use the device?
o Is this congruent with the clinician*s advice?
o Is it sufficient to achieve the desired clinical result?
2. To assess the implanters* experience with the Freedom SCS system:
o Technical difficulties or unforeseen problems during implantation
o Implantation duration from skin incision to electrode entry
3. To determine additional beneficial effects such as:
o Patient satisfaction with treatment
o Reduced visits to health care institutes for chronic back and leg pain
o Improved work status
o Improved quality of life function via the ODI and EQ-5D questionnaires at 12
months compared to baseline
o Reduction in use of analgesics
o Reduced operating theater time, skin to skin time, and fluoroscope time
4. To monitor non-device and non-SCS-related adverse events (e.g., new disease
states, unrelated death).
Background summary
Conventional SCS systems have been available for patients for over 20 years.
The implant of a conventional SCS systems happens in two fases: "A trial" and
"full implant". The leads are externalized during a trial and connected to an
external trial stimulator. A "full" or permanent implant" will replace the
temporary system If the patient shows the necessary pain relief. The extensions
are to be removed and the leads will be connected to an IPG (implantable pulse
generator).
The Freedom SCS system works through wireless technology. The electrodes are
implanted and engaged by a wireless external battery unit. The electrodes are
not externalized and connected to an external trials stimulator. The same
electrodes and wireless external unit can be used after the trial if the
patient shows the necessary pain relief. There is no need for further surgery
in case of a successful trial. The patient will be advised to have the
electrodes removed If he/she does not show the necessary pain relief.
Study objective
The purpose of this study is to assess the safety and effectiveness of the
Freedom SCS (spinal cord stimulation) System for the treatment of chronic back
and leg pain secondary to failed back surgery syndrome (FBSS) over a follow-up
period of one year. (See Appendix A in protocol for a description of the
Freedom SCS System)
Study design
This is a , prospective cohort post-market study. Subjects will be placed in
one of three cohorts based on their reported baseline pain locations. The
cohorts include the following:
• Leg Pain Only - Pain localized to unilateral pain of the leg (thigh, knee,
calf, or foot).
• Back Pain Only - Pain localized to the low back or buttocks.
• Back pain and leg pain - Pain localized to both the low back and legs (back,
buttocks, thigh, knee, calf, or foot).
Investigators will have the option to select one or more stimulators for
stimulation at the spinal cord or at the dorsal root ganglion (DRG).
Stimulation programs include tonic stimulation, high frequency stimulation or
burst stimulation, all of which may be selected via the same implant.
Subjects will return the hospital on 8 different occasions (baseline, implant,
trial evaluation, 6 weeks, 3 months, 6 months, 9 months and 12 months). The
study will end after a total period of 12 months
Study burden and risks
The implantation of an SCS system involves risks that are similar to other
spinal surgical procedures. In addition, implantation or use of a
neurostimulation system containing the elements present in the Freedom SCS
System includes, but is not limited to, the following risks:
• Allergic or immune system response to implanted material
• Infection
• Bleeding
• Leakage of cerebrospinal fluid
• Inadequate pain relief
• Hematoma that can result in paralysis
• Trauma to the spinal cord
• Uncomfortable and/or extraneous stimulation, including jolting or shocking
sensations
• Seroma at the implant site
To protect the subject from these risks, all investigators have previous
experience with SCS and will be trained on the Freedom SCS System Instructions
for Use and User Manual prior to study commencement.
E. Las Olas Blvd Suite 201 901
Fort Lauderdale Fl 33301
US
E. Las Olas Blvd Suite 201 901
Fort Lauderdale Fl 33301
US
Listed location countries
Age
Inclusion criteria
• Appropriate Freedom SCS candidate as affirmed by study investigator
• Candidate has a stable spine not suitable for further surgery as confirmed by physician
• 18 years of age or older (no upper age limit)
• Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back
• At least 6 months since last surgical procedure on the spine
• Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain)
• Pain duration of at least 6 months
• Expected lifespan of at least two years
• Able to comply with study requirements
• Gives informed consent for study participation
Exclusion criteria
• A consistent VAS score of 100 over the past 24 hours as established at Visit 1
• A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy)
• Pregnant or planning to become pregnant
• Known or suspected substance abuse within the last 2 years
• Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion
• Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events)
• Documented allergy to Freedom SCS material components
• Co-existing pain condition or participation in another clinical study that could confound the results of this study
• History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL55060.028.15 |