Clinical trial NCT03480893: Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication
Official title: Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication (Size-study): a Multi-center, Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stenoses, Spinal
Keywords: laminectomy
laminotomy
lumbar canal stenosis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Park MC
name: Maasstad Hospital
First posted: 2018-03-29
Enrollment: 174
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not available.

Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Study design: Double-blinded multi-centre randomised controlled trial Study population: In total 236 patients are to be included. The inclusion criteria are: subjects \> 40 years of age with at least 12 weeks of complaints of intermittent neurogenic claudication based on MRI confirmed of LSS, with sufficient knowledge of the Dutch language.

Intervention: Small size interarcuair decompression versus conventional laminectomy.

Main study parameters/endpoints: Primary outcome is the Modified Roland Morris Questionnaire. Secondary outcomes are leg pain, back pain and a 6 minute walk test amongst others.

Nature and extent of the burden and risks associated with participation: based on available literature , it is believed that the risks associated with small size interarcuair decompression are no greater than that associated with a laminectomy, although these will be examined.

Detailed description: Intermittent neurogenic claudication (INC) caused by a lumbar spinal canal stenosis (LSS) is the most frequent reason for spinal surgery in the elderly. Multiple, less invasive surgical techniques are applied without sufficient evidence for benefits for patients or society.

The classic symptoms of INC are leg pain, which can be exacerbated with prolonged walking and standing and/or lumbar extension, and is associated with back pain. Severe stenosis is common in the elderly spine with 30.4% of the population having severe stenosis. However, only 17.5% have complaints of INC.

Conservative treatment, such as physical therapy or pain medication, may give some relief of symptoms. However, surgical treatment is considered to be the gold standard for patients with INC caused by LSS. The first technique ever described to widen the lumbar spinal canal is the wide bony decompression (laminectomy), which is still a widely used technique. However, since INC is often accompanied by back pain, and this to post-operative back pain, it is hypothesized that a wide decompression is a ground for potential instability. Hence, less invasive techniques, such as interarcuair decompression, were developed and implemented.

Recent studies claim that a limited bony decompression is the new 'golden standard' therapy for patients with INC. Limited bony decompression is believed to give less muscle damage and thus a faster postoperative recovery. Furthermore, wide bony decompression (such as a laminectomy) is believed to result in lumbar instability and iatrogenic scoliosis. Performing a procedure with potential more complications in a - generally - elderly population could at least be described as doubtful. The assumption is often made that after a wide decompression recurrence of the complaints must be scarce. However, a (cost-) effectiveness study, which evaluates the effectiveness of small bony decompression compared to a 'classical' extensive bony decompression, has not been performed yet. The opinions on this matter are diverse. A laminectomy involves the removal of more bone and structures at the back of the spine which may result in longer hospitalization and loss of productivity, but it could also lead to spinal instability on the long term. However, the risk of an insufficient decompression may be higher, potentially leading to more reoperations.

By the means of this double-blinded, multi-center randomized controlled trial the investigators will determine the (cost-) effectiveness of a limited bony decompression compared to a wide bony decompression in patients with INC.

Eligibility criteria: Inclusion Criteria:

* At least 12 weeks of complaints of INC
* Magnetic resonance imaging showing LSS
* Age \>40 years of age
* Sufficient knowledge of the Dutch language
* Signed informed consent

Exclusion Criteria:

* History of lumbar spine surgery
* \>2 lumbar levels operation or needed discectomy
* Degenerative spondylolisthesis \> grade 1 (on a scale of 1 to 4), scoliosis or disc herniation
* ASA-classification \>3
* Serious psychopathology
* Pregnancy
* Active malignancy
* Plans to move abroad during study period

Primary outcomes:
measure: Change on the Modified Roland-Morris Disability Questionnaire
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Secondary outcomes:
measure: Change on the Numeric Rating Scale for leg pain
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Change on the Numeric Rating Scale for back pain
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Changes on the timed-up and go test
timeFrame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
measure: Changes on the 6-minute walk test
timeFrame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
measure: Changes on Neurological examination
timeFrame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
measure: Changes on the Timed Chair-Stand-Test (TCST)
timeFrame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
measure: Changes on the Oswestry Disability Index
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Changes on Functional lumbar x-rays
timeFrame: baseline, 6 weeks
measure: Perceived recovery
timeFrame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Patient satisfaction
timeFrame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Changes on the SF-36
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Complications
timeFrame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Changes on the EuroQoL (EQ-5D)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
measure: Costs of treatment measured using cost questionnaires filled out by the patients
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Biswadjiet Harhangi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arjun Sharma J, Gadjradj PS, Peul WC, van Tulder MW, Moojen WA, Harhangi BS; SIZE-study group. SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. BMJ Open. 2020 Oct 6;10(10):e036818. doi: 10.1136/bmjopen-2020-036818.