Back to resultsOpen Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
Primary Purpose
Lumbar Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microdiscectomy
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar disc herniation , Open Discectomy, Micrdiscectomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Open discectomy
Microdiscectomy
Arm Description
This group of patients are treated by open discectomy
This group of patients are treated by Microdiscectomy
Outcomes
Primary Outcome Measures
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
Oswestry disability index
Oswestry disability index in a measurement of functional ability of patients regarding pain and daily activities
Secondary Outcome Measures
Full Information
NCT ID
NCT04112485
First Posted
September 27, 2019
Last Updated
May 8, 2020
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04112485
Brief Title
Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
Official Title
Open Discectomy Versus Microscope Assisted Discectomy for Treatment of Symptomatic Lumbar Disc Herniation: a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2015 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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. All the patient was suffering from 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar disc herniation , Open Discectomy, Micrdiscectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open discectomy
Arm Type
Other
Arm Description
This group of patients are treated by open discectomy
Arm Title
Microdiscectomy
Arm Type
Other
Arm Description
This group of patients are treated by Microdiscectomy
Intervention Type
Procedure
Intervention Name(s)
Microdiscectomy
Other Intervention Name(s)
Open discectomy
Primary Outcome Measure Information:
Title
Visual analogue score
Description
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
Time Frame
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
Title
Oswestry disability index
Description
Oswestry disability index in a measurement of functional ability of patients regarding pain and daily activities
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.
12. IPD Sharing Statement
Citations:
PubMed Identifier
32539752
Citation
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.
Results Reference
derived
Learn more about this trial
Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
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