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

NCT06757816 | Not Yet Recruiting

• 1 other identifier: accessory rods and iliac screw
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbosacral

Keywords

accessory; fixation; rod; iliac; screws; L5; S1

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (1)

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.

Interventions

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

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

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (4)

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

  PMID: 26516498 BACKGROUND

• 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.

  PMID: 2071615 BACKGROUND

• 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.

  PMID: 24600139 BACKGROUND

• 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.

  PMID: 1387975 BACKGROUND

Central Study Contacts

Ebram Eissa Samaan, bachelor of medicine

CONTACT

01205874949; Abram.15235477@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator and resident orthopedic surgeon at Assiut university hospitals

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: January 30, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

EG (1)