Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication
Size
1 other identifier
interventional
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJuly 27, 2022
July 1, 2022
3.1 years
March 17, 2018
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change on the Modified Roland-Morris Disability Questionnaire
This is a 24-point Dutch questionnaire that is designed to assess the physical disability in patients, due to lower back pain.
baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Secondary Outcomes (14)
Change on the Numeric Rating Scale for leg pain
baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Change on the Numeric Rating Scale for back pain
baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the timed-up and go test
baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the 6-minute walk test
baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on Neurological examination
baseline, 6 months, 12 months, 24 months and 48 months after surgery
- +9 more secondary outcomes
Study Arms (2)
Small size interarcuair decompression
EXPERIMENTALPatients will undergo small size interarcuair decompression
Laminectomy
ACTIVE COMPARATORPatients will undergo laminectomy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Park MCcollaborator
- Maasstad Hospitalcollaborator
Study Sites (1)
Erasmus MC
Rotterdam, South Holland, 3015 CE, Netherlands
Related Publications (1)
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.
PMID: 33028548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Biswadjiet Harhangi
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD-candidate
Study Record Dates
First Submitted
March 17, 2018
First Posted
March 29, 2018
Study Start
March 1, 2020
Primary Completion
April 1, 2023
Study Completion
April 1, 2024
Last Updated
July 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After final publication of manuscript without time limit.
- Access Criteria
- Anonymized
After final publication of manuscript the data set will be available from the authors or journal of publication. Anonymized clinical data will be available.