Outcome of Accessory Rods and Ilic Fixation for Distal Augmentation of S1 Fixation

Not Applicable

Not yet recruiting

• Conditions: Lumbosacral

• Registration Number: NCT06757816
• Lead Sponsor: Assiut University

Brief Summary

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Study Start: 2025-01-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• The study excludes patients who are less than 18 years and more than 90 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Outcome of accessory rod and iliac fixation for distal augmentation of S1 fixation	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.

Secondary Outcome Measures

Name	Time	Method
Pain Relief	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.	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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Asyut, Egypt