Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis

Study Overview
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Brief Summary
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This study compare the results of 2 methods in surgical treatment of Lumbar spine stenosis.These are microdecompresssion and open decompression with posterior stabilization. 100 patients are involved in this study who divided in 2 groups.Each group was treated with one method and follow up done which showed both method are effective with better results in those patients treated with microdecomppression.

Detailed Description
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This randomized controlled study was conducted between January 2016 and October 2018. One hundred patients were involved in this study. All these patients were suffered from radicular leg pain with MRI features of multilevel lumbar spinal stenosis and were treated by conservative treatment of medical treatment and physiotherapy without benefit for (6) months. Those patients were divided into two groups; Group A, (50) Microdecompression, and Group B, (50) patients who were treated by open wide laminectomy and posterior stabilization. Both groups of patients were followed up with ODI (Oswestry disability index) and VAS (Visual analogue score) for the back and leg pain for one year. Results: The results showed that both groups got significant improvement regarding Oswestry disability index. Regarding back pain, there was a significant improvement in both groups with better results in-group A due minimal tissues injury as the advantage of minimal invasive technique. In both groups, there were marked improvement of radicular leg pain postoperatively. Conclusions: Both Microdecompression and wide open laminectomy with posterior stabilization were effective in treatment of multilevel lumbar spinal stenosis with superior results of Microdecompression regarding less back pain postoperatively with less blood loss and soft tissue dissection.

Official Title
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Comparative Study Between Microdecompression and Open Decompression With Posterior Stabilization for Symptomatic Lumbar Spine Stenosis

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: Microdecompression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients were suffered from back pain of different degrees with spinal claudication Exclusion Criteria: Smoking Diabetic patients, Previous spinal surgery, any neuromuscular disorder like poliomyelitis, and vertebral instability proved by Dynamic plain radiographs

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open<br>Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis | Procedure: Microdecompression<br>* comparative surgical treatment<br>* Other names: Open decompression with posterior fixation;|
| Other: Microscope<br>Microscopically done decompression of lumbar spine stenosis who are symptomatic | Procedure: Microdecompression<br>* comparative surgical treatment<br>* Other names: Open decompression with posterior fixation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index | For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement) | It was measured at 12 months after operation | 
| Visual analoge score | This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain | It was measured at 12 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microdecompression, laminectomy, pain, stenosis