Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microdecompression
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Microdecompression, laminectomy, pain, stenosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Open
Microscope
Arm Description
Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis
Microscopically done decompression of lumbar spine stenosis who are symptomatic
Outcomes
Primary Outcome Measures
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)
Visual analoge score
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04087694
First Posted
September 11, 2019
Last Updated
October 15, 2019
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04087694
Brief Title
Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis
Official Title
Comparative Study Between Microdecompression and Open Decompression With Posterior Stabilization for Symptomatic Lumbar Spine Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2016 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Microdecompression, laminectomy, pain, stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open
Arm Type
Other
Arm Description
Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis
Arm Title
Microscope
Arm Type
Other
Arm Description
Microscopically done decompression of lumbar spine stenosis who are symptomatic
Intervention Type
Procedure
Intervention Name(s)
Microdecompression
Other Intervention Name(s)
Open decompression with posterior fixation
Intervention Description
comparative surgical treatment
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
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)
Time Frame
It was measured at 12 months after operation
Title
Visual analoge score
Description
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain
Time Frame
It was measured at 12 months after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherwan Hamawandi
Organizational Affiliation
Hawler medical university / college of medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I want to share all my research with other researcher
Citations:
PubMed Identifier
31827656
Citation
Hamawandi SA, Sulaiman II, Al-Humairi AK. Microdecompression versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis: A Randomized Controlled Trial. Pain Res Manag. 2019 Nov 7;2019:7214129. doi: 10.1155/2019/7214129. eCollection 2019.
Results Reference
derived
Learn more about this trial
Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis
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