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

A

Assiut University

Status

Not yet enrolling

Conditions

Lumbosacral

Treatments

Procedure: accessory rod and iliac fixation for distal augmentation for S1 fixation.

Study type

Interventional

Funder types

Other

Identifiers

NCT06757816
accessory rods and iliac screw

Details and patient eligibility

About

To assess radiological and clinical outcome of use of accessory rod and iliac fixation for distal augmentation of L1 fixation

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

15 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

A case series of patients who underwent extension of fixation for L5 S1 fusion
Other group
Treatment:
Procedure: accessory rod and iliac fixation for distal augmentation for S1 fixation.

Trial contacts and locations

1

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Central trial contact

Ebram Eissa Samaan, bachelor of medicine

Data sourced from clinicaltrials.gov

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