The primary objective of this study is to quantify the reduction in lumbar pain in a GelStix* treatment group compared with a control group receiving a saline solution injection as placebo.The secondary objectives are to assess: 1. the impact of…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lumbar pain intensity measured on Numeric Rating Scale at baseline and 6 months
post-treatment
Secondary outcome
1. Changes in disability: Owestry Disability Index,
2. Changes in health related quality of life: EuroQualityOfLife-5 dimensions
questionnaire,
3. Reliance on medication to relieve pain: type and dose of analgesics
4. Device-related adverse events assessed up to one year
Background summary
Degenerative Disc Disease (DDD) is one of the most common spinal pathologies,
affecting up to 10-15 % of adults. The degeneration is associated with
diminished water-binding capabilities of the nucleus pulpous leading to disc
dehydration, volume reduction, changes in cellular activity, biomechanical
changes and painful symptoms. Patients are initially treated with non-surgical
pain-management techniques, such as anti-inflammatory medications and physical
therapy, but these therapies often provide only temporary relief. When
non-surgical intervention fails, fusion or total disc arthroplasty are often
prescribed, both of which are highly invasive surgeries with significant
associated morbidity. Clearly, a meaningful solution for the treatment gap
existing between conservative care and invasive surgical intervention is needed.
The purpose of this study is to evaluate the efficacy of treatment with the
GelStix* device in a patient population that had no benefit from conservative
care.
Study objective
The primary objective of this study is to quantify the reduction in lumbar pain
in a GelStix* treatment group compared with a control group receiving a saline
solution injection as placebo.
The secondary objectives are to assess:
1. the impact of treatment with GelStix* on disability compared with the
control group
2. the impact of treatment with GelStix* on health related quality of life
compared with the control group
3. the impact of treatment with GelStix* on reliance on medication to relieve
the pain compared with the control group
4. the acute and long-term safety of the GelStix* device and implant system
Study design
Double-blind, prospective, randomized, placebo-controlled, outcome study
Intervention
Treatment group: intradiscale implantation of the GelStix* Nucleus Augmentation
Device (STX-1835S GelStix*, Replication Medical, Inc. - Cranbury, NJ, USA).
Placebo group: intradiscal injection with saline (1 mL NaCl 0.9%).
Study burden and risks
DDD is one of the most common spinal pathologies, impacting up to 10-15 % of
adults. Whereas non-invasive therapies often provide only temporary relief,
patients are often recommended for fusion or total disc arthroplasty, both of
which are highly invasive surgeries with significant associated morbidity.
Clearly, a meaningful solution for the treatment gap existing between
conservative care and invasive surgical intervention is needed.
As with a conventional surgical procedure and pain management treatments, there
is a possibility of infection, bleeding, nerve damage and/or limited motion as
a result of the procedure. There is also a chance that the nucleus augmentation
implant will not resolve difficulties that the patient has with regard to pain
and functioning. Risks associated with use of nuclear augmentation may include
displacement leading to nerve or spinal cord compression and injury. If the
surgeon encounters great difficulty in completing the nuclear augmentation, he
may choose not to proceed with implantation. Other risks include, annular tear,
extrusion into the epidural space. In order to minimize the likelihood of
complications, only physicians trained in interventional or diagnostic
procedures such as discography will perform the nuclear augmentation procedure
on a patient.
Literature on the GelStix* support the implementation of the study. There has
been only a single complication and it was deemed by the investigators to be
due to a surgically misplaced implant. Clinical risks of expulsion and endplate
remodeling have proven to be low-probability to non-existent. On the other
hand, the published data support the clinical benefit in treatment of
discogenic pain. Most patients experienced significant and sustained pain and
disability reductions assessed by the validated Visual Analog Scale and
Oswestry Disability Index.
Via Pietro Capelli 1
Viganello 6962
CH
Via Pietro Capelli 1
Viganello 6962
CH
Listed location countries
Age
Inclusion criteria
- Age between 18-66 years.
- One or two levels of lumbar degenerative disc disease on magnetic resonance imaging (MRI) scan with Pfirrmann grade 2, 3 or 4.
- Positive discography
- Predominant persistent, nociceptive low back pain that worsens with axial loading and improves with recumbence of at least 12 weeks duration.
- Failure to have symptoms resolved or reduced following at least 12 weeks conservative care (pain medication and/or physical therapy).
- Annulus must be competent as determined by lumbar discography
- Negative medial branches block results.
- Patients presenting with a baseline level scores evaluated by NRS of at least 5/10.
- Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation
Exclusion criteria
- Radiculopathy caused by nerve root compression.
- Frank herniations, extruded or sequestered fragments, bulge/protrusions >3mm at any lumbar disc level.
- Greater than grade 4 annular tear (Modified Dallas Grading) at any lumbar disc level.
- Severe symptomatic central, foraminal or lateral recess stenosis, spondylolysis, spondylolisthesis, acute fractures, or ankylosing spondylitis at any lumbar disc level.
- Coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation.
- Active infection, systemic or localized; any disease process or condition that may make the effect of the treatment difficult to evaluate (e.g. cancer, substance abuse, etc.)
- Previous surgery at any lumbar disc level.
- Disc height less than 5mm at the symptomatic level, or less than 50% of the highest lumbar disc
- Presence of Schmorls nodes at the implanted level.
- Females of childbearing age that are known to be pregnant or wishing to be pregnant during the study.
- Psychological disorders or factors that may impact upon treatment outcomes or compliance (e.g. severe depressions).
- Failure to understand informed consent or participation in any other clinical study.
- BMI (Body Mass Index (kg/m2) of >= 35
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02763956 |
| CCMO | NL57568.091.16 |