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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Microdecompression

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 66 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Open; Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis	Procedure: Microdecompression; comparative surgical treatment; Other Names: Open decompression with posterior fixation
OTHER: Microscope; Microscopically done decompression of lumbar spine stenosis who are symptomatic	Procedure: Microdecompression; comparative surgical treatment; Other Names: Open decompression with posterior fixation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: Sherwan Hamawandi, Hawler medical university / college of medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2016
• Primary Completion (ACTUAL): October 4, 2018
• Study Completion (ACTUAL): October 30, 2018

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pain; stenosis; laminectomy; Microdecompression
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: HMU/SHERWAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I want to share all my research with other researcher

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No