Lumbar Disc HerniationNCT04112485
Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
A study testing Microdiscectomy in people with Lumbar Disc Herniation, run by Hawler Medical University.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 46 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Microdiscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2015to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 46 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.
About this study
Official title: Open Discectomy Versus Microscope Assisted Discectomy for Treatment of Symptomatic Lumbar Disc Herniation: a Comparative Study
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
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Microdiscectomy
- Keywords
- Lumbar disc herniation , Open Discectomy, Micrdiscectomy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodiscectomyProcedure or surgery
Also called Open discectomy
| Study group | Role | What they receive |
|---|---|---|
| Open discectomy | Other | This group of patients are treated by open discectomy Receives: Procedure: Microdiscectomy |
| Microdiscectomy | Other | This group of patients are treated by Microdiscectomy Receives: Procedure: Microdiscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start4 Mar 2015
- Primary completion15 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112485
- Sponsor's protocol ID
- HMU/Sherwan3
- Status last verified
- May 2020
- First submitted
- 27 Sep 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32539752
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Discectomy Versus Microscope Assisted Discectomy for Treatment of Symptomatic Lumbar Disc Herniation: a Comparative Study
- ClinicalTrials.gov ID
- NCT04112485
- Acronym / sponsor ID
- HMU/Sherwan3
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar disc herniation , Open Discectomy, Micrdiscectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 4 Mar 2015 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open discectomy | Other | Procedure: MicrodiscectomyThis group of patients are treated by open discectomy |
| Microdiscectomy | Other | Procedure: MicrodiscectomyThis group of patients are treated by Microdiscectomy |
Who may qualify
- Ages
- 19 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrodiscectomyAlso: Open discectomy | Procedure or surgery | Microdiscectomy, Open discectomy |
Primary outcome
Visual analogue score
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
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
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
Oswestry disability index in a measurement of functional ability of patients regarding pain and daily activities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Derived from this study: PubMed 32539752Hamawandi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microdiscectomy in people with Lumbar Disc Herniation, run by Hawler Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.