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

NCT ID: NCT06757816

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2026-04-30

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

Conditions

Lumbosacral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A case series of patients who underwent extension of fixation for L5 S1 fusion

Group Type: OTHER

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ebram Eissa Moussa

principal investigator and resident orthopedic surgeon at Assiut university hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Ebram Eissa Samaan, bachelor of medicine

Role: CONTACT

Abram.15235477@med.aun.edu.eg

01205874949 ext. +20

Facility Contacts

Amany Omar, Vice dean of graduate studies

Role: primary

vp_grad@aun.edu.eg

+2088 22080150 ext. +20

References

Thomson S. Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096.

Reference Type: BACKGROUND

PMID: 26516498 (View on PubMed)

Herkowitz 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.

Reference Type: BACKGROUND

PMID: 2071615 (View on PubMed)

Chakravarty 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.

Reference Type: BACKGROUND

PMID: 24600139 (View on PubMed)

Gill 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.

Reference Type: BACKGROUND

PMID: 1387975 (View on PubMed)

Other Identifiers

accessory rods and iliac screw

Identifier Type: -

Identifier Source: org_study_id