Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel 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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Constriction, Pathologic Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

41 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microdecompression

Procedure

comparative surgical treatment

Other names: Open decompression with posterior fixation

Primary outcomes

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)
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

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 12, 2019
Registry last updated: Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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