The objective of the study is to provide clinical evidence proving that the Aperius* PercLID* System is safe and non-inferior to Standalone Decompressive Surgery (decompressive spinal surgery without additional instrumentation/fixation) with regards…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the mean percentage change from baseline
in Physical Function at 1 year follow-up using the study subject completed
Zurich Claudication Questionnaire (ZCQ).
Secondary outcome
- Mean percentage change from baseline in Physical Function, using the study
subject completed ZCQ at 14 days, 6 weeks, 6, 24, 36, 48 months
- Mean percentage change from baseline in Symptom Severity, using the study
subject completed ZCQ at 14 days, 6 weeks, 6, 12, 24, 36, 48 months
- Percentage of patients being satisfied with the treatment assessed using the
study subject completed ZCQ at 14 days, 6 weeks, 6, 12, 24, 36, 48 months
- Mean percentage change from baseline in Leg Pain VAS Scores at 14 days, 6
weeks, 6, 12, 24, 36, 48 months
- Mean percentage change from baseline in Quality of Life using the study
subject completed SF-36 v2 questionnaire at 14 days, 6 weeks, 6, 12, 24, 36, 48
months
Note: The SF-36 v2 questionnaire profiles physical and mental health in 8
different dimensions including: Physical Functioning, Role Physical, Bodily
Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental
Health, each of which will be analyzed separately and combined as physical
component summary (PCS) and mental component summary (MCS).
- Changes in the stenosis of the spinal canal assessed by MRI at the follow-up
time points
- Changes in the bony structures assessed by CT at the follow-up time points
- Percentage of subjects requiring surgical intervention at the index level in
the follow-up period
- Proportion of subjects with complications at the secondary surgical
intervention
- Proportion of subjects with SADE*s
- Determining if there is a correlation between sagittal balance or other
radiological findings and the clinical outcomes
- Proportion of subjects with improvement of symptoms, symptoms recurrence,
decreased therapeutic response, no therapeutic response and treatment failure
at 14 days, 6 weeks, 6, 12, 24, 36, 48 months
Background summary
Degenerative Lumbar Spinal Stenosis (DLSS) is a slowly progressing disease,
characterized by narrowing of the spinal canal and/or the neural foramina by
degenerative changes in the spine: such as hypertrophy of the facet joints,
folded and thickened yellow ligament, formation of osteophytes, and bulging of
the intervertebral disc.
Symptom relief can be obtained by relieving the pressure on the neural
structures of the back. This study will compare 2 surgical procedures, (that
are also available without participation to the study): standalone
decompressive surgery and the Aperius* PercLID* System .
Study objective
The objective of the study is to provide clinical evidence proving that the
Aperius* PercLID* System is safe and non-inferior to Standalone Decompressive
Surgery (decompressive spinal surgery without additional
instrumentation/fixation) with regards to clinical outcomes in patients
suffering from DLSS with Neurogenic Intermittent Claudication (NIC), relieved
by flexion.
Study design
A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the
Effectiveness and Safety of the Aperius* PercLID*System Versus Standalone
Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic
Intermittent Claudication. The anticipated duration of the study includes
approximately 24 months for recruitment and 48 months follow-up, for a total of
approximately 72 months.
Intervention
Depending on the outcome of the randomization, the study subject will receive
either the Aperius* procedure or the Standalone Decompressive Surgery.
Study burden and risks
Risks:
1)There is exposure to radiation from X-rays and CT*s taken to diagnose and
follow up the spinal stenosis, the implant after surgery (in the Aperius*
PercLID* System arm) or the status of your spine (in the Standalone
Decompressive Surgery arm). There is also radiation exposure during both
surgeries from fluoroscopy that is needed for precise navigation during both
types of surgery. The radiation may be harmful to an unborn child. Thus, a
woman who is or could become pregnant, must have a pregnancy test done prior to
enrolment into the study. If the test is positive, these tests will be
cancelled, and study subjects will not be eligible for enrolment into this
study. Also breastfeeding will exclude from participation. MRI involves no
radiation exposure.
2)Possible risks related to surgery in general (for both study groups). Every
surgical procedure and medication to put study subject asleep has certain
risks. These risks are independent from participation in this study. Potential
risks to any surgical procedure include but are not necessarily limited to:
-Thrombosis/emboli
-Hematoma
-Reaction to anesthesia
-Allergic reaction to medication
-Blood loss
-Infection / inflammatory reaction / fever
-Problems with the heart and/or the lungs
-Psychological problems
3)Possible risks related to the Aperius* PercLID* System
-Dislocation or migration of the implant
-Foreign Body reaction -
-Device malfunction
-Allergy to Device materials
-Spinous Process Fracture
-Persistence of pain or worsening of symptoms
-Revision surgery (with or without removal of the device)
-Subsidence of the Aperius* into the spinous processes
-Damage to the facet joints
-Temporary back pain at the implanted level due to the incision and/or
stretching of the ligaments and/or change in posture
4)Possible risks related to the Standalone Decompressive Surgery
-Damage to ligaments
-Persistence of pain or worsening of symptoms
-Fractures of the bones of the back
-Damage to nerve roots
-Dural tears (leakage of the fluid around the spinal nerve, due to damage of
the protecting tussue)
-Cauda Equina syndrome (includes symptoms of back and leg pain, urinary
retention, fecal incontinence, numbness and weakness in the legs and abnormal
gait)
-Revision surgery
-Lumbar instability (due to the removal of bony and/or ligamentous tissue in
the treated spine segment)
-Paraplegia
Benefits:
If successful, either treatment will partially or completely resolve study
patients' symptoms associated with the Lumbar Spinal Stenosis, restore or
improve study patients ability to move and walk, decrease or eliminate the
back/leg/buttock/groin pain and may improve the quality of life.
Patients do not need to participate in this study to receive these treatments
and its benefits, the information from this study can help doctors to
understand how to improve the handling and treatment of patients suffering from
Degenerative Lumbar Spinal Stenosis. Information collected in this study can
support the development of new devices and therapies.
At this point in time we do not know exactly if the treatment with the APERIUS*
PercLID* System provides the same results as treatment with Standalone
Decompressive Surgery, by means of this trial we would like to find this out.
In general we expect to obtain good results for both treatment groups with
regards to improvements in back / leg / buttock / groin pain, physical function
and quality of life.
Leuvensesteenweg 369/6
1932 Zaventem
BE
Leuvensesteenweg 369/6
1932 Zaventem
BE
Listed location countries
Age
Inclusion criteria
*Presence of symptomatic DLSS in the L1-L5 region confirmed by MRI at 1 or maximum 2 levels
*Presence of NIC, defined as a feeling of paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking or prolonged standing, with or without back pain, buttock and/or groin pain which are relieved in flexion
*Leg pain must be more pronounced than back pain. Leg pain VAS score must at least be 2 points higher than back pain VAS score.
*Average disc height *defined as the mathematical mean of the anterior and the posterior disc height measured in the mid-sagittal MRI- at the index level(s) is * 5mm.
*According to the current standard of care patient would be candidate for Standalone Decompressive Surgery (no instrumentation, no stabilization or fusion)
*Patient states availability and willingness to perform all follow-up examinations
*Patient has signed Informed Consent form (ICF)
*Patient is 21 years old or older
*Duration of the patient*s leg symptoms is at least 6 weeks at screening
*Patient has no financial interest in participating in the study (e.g.: workers compensation etc)
Exclusion criteria
*Patient had undergone a previous lumbar surgery at any lumbar level
*Patient has unremitting pain (leg, buttock/groin) in any spinal position
*Patient is candidate for instrumented decompressive surgery (decompression with stabilization/fusion)
*Patient has back pain without leg pain
*Degenerative Spondylolisthesis greater than Grade 1 on the Meyerding grading system
*Spondylolysis (fracture or defect of the isthmus/pars interarticularis)
*Spinous process fracture at any lumbar level
*Ankylosis at the affected level
*Fixed motor deficit
*Symptomatic DLSS at more than 2 levels in the lumbar region
*Spinal stenosis is present at L5-S1 level
*Symptomatic disc herniation causing radiculopathy
*Patient*s anatomical features do not allow appropriate placement of the device
*BMI of patient equal to or higher than 35
*Scoliosis with Cobb angle * 25°
*Kyphosis requiring surgical correction
*Paget*s disease
*Tumor of the spine
*Presence of vascular claudication
*History of one or more osteoporotic spinal fragility fracture(s), determined on full spine X-ray
*Active systemic infection or local infection at the target level(s)
*Major Depression according to the DSM IV criteria
*Dementia and/or inability to give Informed Consent
*Unable to complete the study
*Pregnancy, breastfeeding or planned pregnancy
*Allergy to any of the components of the Aperius device, inserter or the distractors.
*Patients with specific contraindications for MRI: (claustrophobia, cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, neurostimulator, insulin pump, implanted drug infusion device, bone growth/fusion stimulator and cochlear -, or otologic implant)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NCT00905359 |
| CCMO | NL28522.098.10 |