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

NCT04087694 | Completed

• 1 other identifier: HMU/SHERWAN
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Microdecompression; laminectomy; pain; stenosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Open

OTHER

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

Procedure: Microdecompression

Microscope

OTHER

Microscopically done decompression of lumbar spine stenosis who are symptomatic

Procedure: Microdecompression

Interventions

Microdecompression PROCEDURE

comparative surgical treatment

Also known as: Open decompression with posterior fixation

Microscope; Open

Eligibility Criteria

• Age: 41 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hawler Medical University: lead

Related Publications (1)

• 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.

  PMID: 31827656 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Pain; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Sherwan Hamawandi

  Hawler medical university / college of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of orthopedic surgery

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: January 3, 2016
• Primary Completion: October 4, 2018
• Study Completion: October 30, 2018
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share