Lumbar SpondylolisthesisNCT03271060
Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
A study testing Posterior lumbar interbody fusion and Inter transverse bone grafting in people with Lumbar Spondylolisthesis, run by Assiut University.
Trial summary
The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Spondylolisthesis
- What is being tested?
- Posterior lumbar interbody fusion and Inter transverse bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lumbar spondylolisthesis
Who cannot join
- infection of lumbar spine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.
While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).
Read the detailed description
In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.
- Conditions
- Lumbar Spondylolisthesis
- Being tested
- Posterior lumbar interbody fusion, Inter transverse bone grafting
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior lumbar interbody fusionProcedure or surgery
Lumbar fusion by screws and inter vertebral cage
Inter transverse bone graftingProcedure or surgery
Inter transverse process bone grafting by bone graft from illiac crest or other sites
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spondylolisthesis1 | Active comparator | Not described Receives: Procedure: Inter transverse bone grafting |
| Lumbar spondylolisthesis 2 | Active comparator | Not described Receives: Procedure: Posterior lumbar interbody fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain
Back pain severity grading mild, moderate, severe
Measured: 1year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Sep 2017 (estimated)
- Primary completion30 Aug 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Posterior inter body fusion and inter transverse process bone graft
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Garamoun Abd El Zaher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271060
- Sponsor's protocol ID
- Lumbar spondylolisthesis
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
- ClinicalTrials.gov ID
- NCT03271060
- Acronym / sponsor ID
- Lumbar spondylolisthesis
- Conditions
- Lumbar Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 1 Sep 2017 (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.
The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.
While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).
Detailed description
In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Posterior inter body fusion and inter transverse process bone graft
| Arm | Type | Receives |
|---|---|---|
| Lumbar spondylolisthesis1 | Active comparator | Procedure: Inter transverse bone grafting |
| Lumbar spondylolisthesis 2 | Active comparator | Procedure: Posterior lumbar interbody fusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lumbar spondylolisthesis
Key exclusion criteria (1 listed)
- infection of lumbar spine
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 |
|---|---|---|
| Posterior lumbar interbody fusionLumbar fusion by screws and inter vertebral cage | Procedure or surgery | Lumbar spondylolisthesis 2 |
| Inter transverse bone graftingInter transverse process bone grafting by bone graft from illiac crest or other sites | Procedure or surgery | Lumbar spondylolisthesis1 |
Primary outcome
Back pain
Time frame: 1year postoperative
Back pain severity grading mild, moderate, severe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior lumbar interbody fusion and Inter transverse bone grafting in people with Lumbar Spondylolisthesis, run by Assiut 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Garamoun, Resident (201091123869, Garamoun.mahmoud@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: 1year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2017.