LumbosacralNCT06757816
Outcome of Accessory Rods and Ilic Fixation for Distal Augmentation of S1 Fixation
A study testing accessory rod and iliac fixation for distal augmentation for S1 fixation. in people with Lumbosacral, run by Assiut University at 1 site in Egypt.
Trial summary
To assess radiological and clinical outcome of use of accessory rod and iliac fixation for distal augmentation of L1 fixation Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Lumbosacral
- What is being tested?
- accessory rod and iliac fixation for distal augmentation for S1 fixation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study will include all patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis.
Who cannot join
- The study excludes patients who are less than 18 years and more than 90 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, Asyut Governorate, 71515
Amany Omar, Vice dean of graduate studies, +2088 22080150 ext. +20, vp_grad@aun.edu.eg
About this study
To assess radiological and clinical outcome of use of accessory rod and iliac fixation for distal augmentation of L1 fixation
Read the detailed description
Lumbar fusion is a surgical procedure that can be utilized to treat a variety of painful and degenerative conditions in the lower back. The most common conditions that indicate the need for an L5 S1 fusion include low back disc degeneration (also known as spondylolisthesis), spinal fractures, recurrent disc herniation, scoliosis, lumbar canal stenosis, and instability resulting from failed spine surgery . The success rate of lumbo sacral fusion surgery is influenced by many factors. These include non-union, hardware breakage or loosening, discitis, osteoporosis, tumors, and pseudoarthrosis . Lumbosacral pseudarthrosis is one of the most common complications in L5 S1 fusion surgery. It is a strong indication for revision surgery if severe symptoms persist. The rate of pseudarthrosis increases based on several parameters, including the number of levels fused, the type of fusion, and medical risk factors for pseudarthrosis .
There are various methods of revision. One such method involves the use of iliac screws in addition to lumbo sacral interbody fusion. This approach improves the outcomes of revision fusion surgery but still carries the risk of rod breakage . S2 alar-iliac (S2AI) screws have been described as another method, but they have some disadvantages like rod breakage, screw misplacement, breach of cortical bone, and injury to neurovascular structures. These structures include superior gluteal vessels, external iliac vessels, pudendal vessels, superior gluteal nerves, sciatic nerve, and sympathetic chain ganglia . Our theory proposes the use of an accessory rod, which offers the advantage of dual rod fixation with a low incidence of rod breakage. We also suggest the free-handed placement of the iliac screw in the iliac bone, which plays a significant role in improving the integrity of the fixation and simplifies the application process.
Multiple-rod constructs could prevent rod breakage and pseudarthrosis while also lowering the revision rate. As a result, they could lead to a better clinical outcome than the 2-rod construct. This approach is based on the principle that increasing the number of rods in the construct can distribute the load more evenly, reducing the risk of rod breakage and pseudarthrosis. This, in turn, could lead to a lower revision rate and better clinical outcomes
- Conditions
- Lumbosacral
- Being tested
- accessory rod and iliac fixation for distal augmentation for S1 fixation.
- Keywords
- accessory, fixation, rod, iliac, screws, L5, S1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accessory rod and iliac fixation for distal augmentation for S1 fixation.Procedure or surgery
patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis.
| Study group | Role | What they receive |
|---|---|---|
| A case series of patients who underwent extension of fixation for L5 S1 fusion | Other | Not described Receives: Procedure: accessory rod and iliac fixation for distal augmentation for S1 fixation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of accessory rod and iliac fixation for distal augmentation of S1 fixation
Union of L5 S1: This outcome is assessed by the presence of bridging bone across the fusion site, evaluated through X-ray imaging.
Measured: 3 months post-operative: Initial assessment of the union. 1 year post-operative: Follow-up to confirm sustained union and assess long-term outcomes.
Secondary outcomes (1)
Pain Relief
his will be assessed by comparing the preoperative and postoperative Visual Analogue Scale (VAS) scores of each patient. The VAS scores will be recorded before the surgery, immediately after the surgery, and at 3 months post-operative to evaluate changes in pain intensity.
Measured: Preoperative: VAS scores will be recorded before the surgery. Immediate Postoperative: VAS scores will be recorded immediately after the surgery. 3 Months Postoperative: VAS scores will be recorded to evaluate changes in pain intensity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LumbosacralStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Eissa Moussa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757816
- Sponsor's protocol ID
- accessory rods and iliac screw
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomson S. Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096.
PubMed 26516498Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
PubMed 2071615Chakravarty A. A survey of attitude of frontline clinicians and nurses towards adverse events. Med J Armed Forces India. 2013 Oct;69(4):335-40. doi: 10.1016/j.mjafi.2013.01.009. Epub 2013 May 9.
PubMed 24600139Gill K, Blumenthal SL. Functional results after anterior lumbar fusion at L5-S1 in patients with normal and abnormal MRI scans. Spine (Phila Pa 1976). 1992 Aug;17(8):940-2. doi: 10.1097/00007632-199208000-00012.
PubMed 1387975
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Accessory Rods and Ilic Fixation for Distal Augmentation of S1 Fixation
- ClinicalTrials.gov ID
- NCT06757816
- Acronym / sponsor ID
- accessory rods and iliac screw
- Conditions
- Lumbosacral
- Keywords
- accessory, fixation, rod, iliac, screws, L5, S1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 3 Jan 2025 (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.
To assess radiological and clinical outcome of use of accessory rod and iliac fixation for distal augmentation of L1 fixation
Detailed description
Lumbar fusion is a surgical procedure that can be utilized to treat a variety of painful and degenerative conditions in the lower back. The most common conditions that indicate the need for an L5 S1 fusion include low back disc degeneration (also known as spondylolisthesis), spinal fractures, recurrent disc herniation, scoliosis, lumbar canal stenosis, and instability resulting from failed spine surgery . The success rate of lumbo sacral fusion surgery is influenced by many factors. These include non-union, hardware breakage or loosening, discitis, osteoporosis, tumors, and pseudoarthrosis . Lumbosacral pseudarthrosis is one of the most common complications in L5 S1 fusion surgery. It is a strong indication for revision surgery if severe symptoms persist. The rate of pseudarthrosis increases based on several parameters, including the number of levels fused, the type of fusion, and medical risk factors for pseudarthrosis .
There are various methods of revision. One such method involves the use of iliac screws in addition to lumbo sacral interbody fusion. This approach improves the outcomes of revision fusion surgery but still carries the risk of rod breakage . S2 alar-iliac (S2AI) screws have been described as another method, but they have some disadvantages like rod breakage, screw misplacement, breach of cortical bone, and injury to neurovascular structures. These structures include superior gluteal vessels, external iliac vessels, pudendal vessels, superior gluteal nerves, sciatic nerve, and sympathetic chain ganglia . Our theory proposes the use of an accessory rod, which offers the advantage of dual rod fixation with a low incidence of rod breakage. We also suggest the free-handed placement of the iliac screw in the iliac bone, which plays a significant role in improving the integrity of the fixation and simplifies the application process.
Multiple-rod constructs could prevent rod breakage and pseudarthrosis while also lowering the revision rate. As a result, they could lead to a better clinical outcome than the 2-rod construct. This approach is based on the principle that increasing the number of rods in the construct can distribute the load more evenly, reducing the risk of rod breakage and pseudarthrosis. This, in turn, could lead to a lower revision rate and better clinical outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A case series of patients who underwent extension of fixation for L5 S1 fusion | Other | Procedure: accessory rod and iliac fixation for distal augmentation for S1 fixation. |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include all patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis.
Key exclusion criteria (1 listed)
- The study excludes patients who are less than 18 years and more than 90 years
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 |
|---|---|---|
| accessory rod and iliac fixation for distal augmentation for S1 fixation.patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis. | Procedure or surgery | A case series of patients who underwent extension of fixation for L5 S1 fusion |
Primary outcome
Outcome of accessory rod and iliac fixation for distal augmentation of S1 fixation
Time frame: 3 months post-operative: Initial assessment of the union. 1 year post-operative: Follow-up to confirm sustained union and assess long-term outcomes.
Union of L5 S1: This outcome is assessed by the presence of bridging bone across the fusion site, evaluated through X-ray imaging.
1 secondary outcome
Pain Relief
Time frame: Preoperative: VAS scores will be recorded before the surgery. Immediate Postoperative: VAS scores will be recorded immediately after the surgery. 3 Months Postoperative: VAS scores will be recorded to evaluate changes in pain intensity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Results publication: PubMed 26516498Thomson S. Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096.
- Results publication: PubMed 2071615Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
- Results publication: PubMed 24600139Chakravarty A. A survey of attitude of frontline clinicians and nurses towards adverse events. Med J Armed Forces India. 2013 Oct;69(4):335-40. doi: 10.1016/j.mjafi.2013.01.009. Epub 2013 May 9.
- Results publication: PubMed 1387975Gill K, Blumenthal SL. Functional results after anterior lumbar fusion at L5-S1 in patients with normal and abnormal MRI scans. Spine (Phila Pa 1976). 1992 Aug;17(8):940-2. doi: 10.1097/00007632-199208000-00012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accessory rod and iliac fixation for distal augmentation for S1 fixation. in people with Lumbosacral, run by Assiut University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebram Eissa Samaan, bachelor of medicine (01205874949 ext. +20, Abram.15235477@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of accessory rod and iliac fixation for distal augmentation of S1 fixation (time frame: 3 months post-operative: Initial assessment of the union. 1 year post-operative: Follow-up to confirm sustained union and assess long-term outcomes.). 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 NCT06757816, which also lists 4 linked publications.
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 7 Jan 2025.