NCT03480893

Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stenoses, Spinal

Interventions

Type	Name	Description
PROCEDURE	small size interarcuair decompression	A median lumbar incision is made and the paravertebral muscles are dissected subperiosteally and retracted unilaterally or bilaterally. Decompression will be applied via decompression of the ligamentum flavum. The lateral recess will be opened bilaterally and a medial facetectomy will be performed in order maintain stability of the segments. Posterior ligaments will be spared. The wound will be closed in layers with or without a suction drain. Patients will be operated with a loupe magnification or microscope depending on the surgeon's preference.
PROCEDURE	Laminectomy	A median lumbar incision is made over the spinous processes, the laminae of the affected level(s) are exposed subperiosteally, and the supraspinous ligament will be incised. The spinous process is removed. The supra and interspinous ligament of the affected level is removed by drill or Kerrison punches. The lamen is removed of the affect level, leaving the facet joint intact. The lateral recess will be opened bilaterally and medial facetectomy will be performed in order to maintain stability of the segments. When a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be removed. The wound will be closed in layers with or without a suction drain. Patients will be operated with loupe magnification or microscope depending surgeon's preference.

Timeline

• Start date: 2020-03-01
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2018-03-29
• Last updated: 2022-07-27

Locations

1 site across 1 country: Netherlands