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IRCT20251203068207N1 IRCT 2026-07-25 Oroumia University of Medical Sciences Comparison of outcomes of surgical interventions in patients with degenerative lumbar spinal stenosis Comparing the treatment outcomes of laminectomy alone, laminectomy with arthrodesis and laminectomy with posterior fusion in degenerative lumbar spinal canal stenosis patients 2026-07-26 anticipated 105 Recruiting https://irct.ir/trial/90530 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Eligible participants who provided written informed consent were randomly assigned to one of three study groups using block randomization with a 1:1:1 allocation ratio. The random allocation sequence was generated by computer software, and participants were assigned according to randomly permuted blocks to ensure balanced group sizes throughout the study. The three study arms consisted of: (1) decompressive laminectomy alone, (2) laminectomy with non-instrumented arthrodesis, and (3) laminectomy with instrumented posterior fusion. N/A Degenerative Lumbar Spinal Stenosis. Intervention 1: Intervention group: Intervention Group 1: Patients will undergo decompressive laminectomy followed by non instrumented arthrodesis. The procedure will be performed by experienced spine surgeons according to the institutional standard protocol. Perioperative care will be identical for all participants. Intervention 2: Intervention group: Intervention Group 2: Patients will undergo decompressive laminectomy followed by instrumented posterior fusion using pedicle screw fixation. All procedures will be performed according to the institutional standard protocol by experienced spine surgeons. Perioperative care will be identical in all groups. Intervention 3: Control group: Control Group: Patients will undergo decompressive laminectomy alone without arthrodesis or instrumentation. Perioperative management and postoperative care will be identical to the other study groups. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available.
public Saeed Pourmoghadam
Shahid Chmran Dormitory ,Tarzi street , Imam khomeini street
Urmia Iran (Islamic Republic of) 5718748983 +98 44 3224 6858 School.saeed@outlook.com Oroumia University of Medical Sciences scientific Saeed Pourmoghadam
Shahid Chmran Dormitory ,Tarzi street , Imam khomeini street
Urmia Iran (Islamic Republic of) 5718748983 +98 44 3224 6858 School.saeed@outlook.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Diagnosis of degenerative lumbar spinal stenosis confirmed by MRI Presence of neurogenic claudication and/or radicular leg pain Failure of conservative treatment for at least 6 months Candidate for lumbar decompression surgery Ability to complete follow-up assessments up to 12 months Written informed consent obtained No evidence of overt lumbar spinal instability Age between 18 and 80 years 18 years 80 years Both Meyerding grade II or higher spondylolisthesis . Anteroposterior translation greater than 3 mm on flexion-extension radiographs Dynamic angular motion greater than 10 degrees Previous lumbar surgery at the affected level Spinal tumor, infection, or traumatic fracture Cauda equina syndrome or progressive neurological deficit Severe scoliosis or significant spinal deformity Severe systemic disease contraindicating surgery Refusal to participate in the study Inability to complete postoperative follow-up M48.06 Spinal stenosis, lumbar region Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: Intervention Group 1: Patients will undergo decompressive laminectomy followed by non instrumented arthrodesis. The procedure will be performed by experienced spine surgeons according to the institutional standard protocol. Perioperative care will be identical for all participants. Intervention group: Intervention Group 2: Patients will undergo decompressive laminectomy followed by instrumented posterior fusion using pedicle screw fixation. All procedures will be performed according to the institutional standard protocol by experienced spine surgeons. Perioperative care will be identical in all groups. Control group: Control Group: Patients will undergo decompressive laminectomy alone without arthrodesis or instrumentation. Perioperative management and postoperative care will be identical to the other study groups. Severity of low back pain. Timepoint: Before surgery, three months after surgery, nine months after surgery, and at the final postoperative follow up visit. Method of measurement: Low back pain severity will be measured using the Visual Analogue Scale for pain. Severity of leg pain. Timepoint: Before surgery, three months after surgery, nine months after surgery, and at the final postoperative follow up visit. Method of measurement: Severity of leg pain will be measured using the Visual Analogue Scale for pain. Lumbar lordosis. Timepoint: Before surgery, three months after surgery, nine months after surgery, and at the final postoperative follow up visit. Method of measurement: Lumbar lordosis will be measured on standing lateral lumbar spine radiographs. Distal lumbar lordosis. Timepoint: Before surgery, three months after surgery, nine months after surgery, and at the final postoperative follow up visit. Method of measurement: Distal lumbar lordosis will be measured on standing lateral lumbar spine radiographs. Proximal segmental lordosis. Timepoint: Before surgery, three months after surgery, nine months after surgery, and at the final postoperative follow up visit. Method of measurement: Proximal segmental lordosis will be measured on standing lateral lumbar spine radiographs. Proximal junctional kyphosis. Timepoint: Before surgery, three months after surgery, nine months after surgery, and at the final postoperative follow up visit. Method of measurement: Proximal junctional kyphosis will be measured on standing lateral spinal radiographs. Patient satisfaction after surgery. Timepoint: At the final postoperative follow up visit. Method of measurement: Patient satisfaction will be assessed using a standardized patient satisfaction questionnaire. Postoperative complications. Timepoint: During hospital stay, three months after surgery, nine months after surgery, and at the final follow up visit. Method of measurement: Postoperative complications will be assessed by clinical examination, medical records, and radiological findings. Length of hospital stay. Timepoint: From hospital admission until discharge. Method of measurement: Length of hospital stay will be calculated from hospital medical records. Need for reoperation. Timepoint: Until the final postoperative follow up visit. Method of measurement: Need for reoperation will be determined from medical records. Oroumia University of Medical Sciences Approved 2024-05-29 Research Ethics Committees of Urmia University of Medical Sciences – Imam Khomeini University Hospit South Khayyam Street, before Jihad Square, Alley 27, Apartment 27, Unit 7 URMIA West Azarbaijan Iran (Islamic Republic of)