Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2019
CompletedFirst Submitted
Initial submission to the registry
September 27, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedMay 11, 2020
May 1, 2020
4.5 years
September 27, 2019
May 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual analogue score
Visual analogue score of back pain and leg pain which represent a score from 0-10 so if patient has no pain so gives 0 and if has severe pain gives 10
Visua analogue score was assessed preoperatively and postoperatively to see how much change in pain can occurred after open discectomy and after Microdiscectomy for 1 year
Oswestry disability index
Oswestry disability index in a measurement of functional ability of patients regarding pain and daily activities
Oswestry disability index was assessed preoperatively and postoperatively to assess how much changes can occur after open discectomy and Microdiscectomy for 1 year after surgery
Study Arms (2)
Open discectomy
OTHERThis group of patients are treated by open discectomy
Microdiscectomy
OTHERThis group of patients are treated by Microdiscectomy
Interventions
Eligibility Criteria
You may qualify if:
- Adults who are symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients. Conservative treatment for 6weeks was failed
You may not qualify if:
- smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hamawandi SA, Sulaiman II, Al-Humairi AK. Open fenestration discectomy versus microscopic fenestration discectomy for lumbar disc herniation: a randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 15;21(1):384. doi: 10.1186/s12891-020-03396-x.
PMID: 32539752DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 27, 2019
First Posted
October 2, 2019
Study Start
March 4, 2015
Primary Completion
August 15, 2019
Study Completion
August 20, 2019
Last Updated
May 11, 2020
Record last verified: 2020-05