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

NCT ID: NCT04087694

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-03

Study Completion Date

2018-10-30

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.

Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open

Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis

Group Type OTHER

Microdecompression

Intervention Type PROCEDURE

comparative surgical treatment

Microscope

Microscopically done decompression of lumbar spine stenosis who are symptomatic

Group Type OTHER

Microdecompression

Intervention Type PROCEDURE

comparative surgical treatment

Interventions

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Microdecompression

comparative surgical treatment

Intervention Type PROCEDURE

Other Intervention Names

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Open decompression with posterior fixation

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
Minimum Eligible Age

41 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherwan Hamawandi

Role: PRINCIPAL_INVESTIGATOR

Hawler medical university / college of medicine

References

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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.

Reference Type DERIVED
PMID: 31827656 (View on PubMed)

Other Identifiers

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HMU/SHERWAN

Identifier Type: -

Identifier Source: org_study_id

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