Spinal FusionNCT03692845
Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
A study testing Transforaminal Lumbar Interbody Fusion either open or minimally invasive in people with Spinal Fusion, run by Assiut University.
Trial summary
A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- Transforaminal Lumbar Interbody Fusion either open or minimally invasive
- 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
- Nov 2018to Oct 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults more than 18 years of age and less than 65 years of age..
- Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
- Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
- Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
- Symptoms not responding to conservative treatment for at least 3 months.
Who cannot join
- Previous spinal fusion or instrumentation.
- Spinal tumours, infection and fractures.
- Patients with severe osteoporosis
- BMI more than 35.
- Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
- Patients not willing to participate in the study
About this study
A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.
Read the detailed description
The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.
- Conditions
- Spinal Fusion
- Being tested
- Transforaminal Lumbar Interbody Fusion either open or minimally invasive
- Keywords
- spine fusion, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Lumbar Interbody Fusion either open or minimally invasiveProcedure or surgery
Spinal fusion procedure through the intervertebral foramen
| Study group | Role | What they receive |
|---|---|---|
| O-TLIF group | Other | Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery. Receives: Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive |
| MI-TLIF group | Other | Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor. Receives: Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability index(Arabic version) 1 month
an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
Measured: 1 month
Secondary outcomes (1)
• Fusion rate as assessed by Bridwell fusion score.
Grade I is defined as fusion with remodelling and trabeculae present; Grade II is an intact graft with incomplete remodelling and no lucency present; Grade III is an intact graft with potential lucency at the cranial or caudal end; Grade IV is absent fusion with collapse/resorption of the graft.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hatem Ahmed Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692845
- Sponsor's protocol ID
- 6272829
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT03692845
- Acronym / sponsor ID
- 6272829
- Conditions
- Spinal Fusion
- Keywords
- spine fusion, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 2 Oct 2018 (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.
A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.
Detailed description
The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O-TLIF group | Other | Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasiveSpinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery. |
| MI-TLIF group | Other | Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasiveSpinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults more than 18 years of age and less than 65 years of age..
- Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
- Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
- Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
- Symptoms not responding to conservative treatment for at least 3 months.
Key exclusion criteria (6 listed)
- Previous spinal fusion or instrumentation.
- Spinal tumours, infection and fractures.
- Patients with severe osteoporosis
- BMI more than 35.
- Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
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 |
|---|---|---|
| Transforaminal Lumbar Interbody Fusion either open or minimally invasiveSpinal fusion procedure through the intervertebral foramen | Procedure or surgery | MI-TLIF group, O-TLIF group |
Primary outcome
Oswestry Disability index(Arabic version) 1 month
Time frame: 1 month
an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
1 secondary outcome
• Fusion rate as assessed by Bridwell fusion score.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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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 Transforaminal Lumbar Interbody Fusion either open or minimally invasive in people with Spinal Fusion, 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 5 inclusion and 6 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 2 Oct 2018. 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?
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?
Oswestry Disability index(Arabic version) 1 month (time frame: 1 month). 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 2 Oct 2018.