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Clinical Trials/NCT04087694
NCT04087694
Completed
Not Applicable

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

Hawler Medical University0 sites100 target enrollmentJanuary 3, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
Hawler Medical University
Enrollment
100
Primary Endpoint
Visual analoge score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2016
End Date
October 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Hawler Medical University

Eligibility Criteria

Inclusion Criteria

  • patients were suffered from back pain of different degrees with spinal claudication

Exclusion Criteria

  • Diabetic patients,
  • Previous spinal surgery,
  • any neuromuscular disorder like poliomyelitis, and
  • vertebral instability proved by Dynamic plain radiographs

Outcomes

Primary Outcomes

Visual analoge score

Time Frame: It was measured at 12 months after operation

This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain

Oswestry disability index

Time Frame: It was measured at 12 months after operation

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)

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