NCT05018377

Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the past decade, spine surgery rates have dramatically increased in parallel to those of other procedural interventions. Persistent pain is a common occurrence after spine surgery, with the most commonly quoted prevalence rates ranging from 10% to 40%. This pain can be classified into failure to alleviate baseline pain, pain resulting from complications (e.g., arachnoiditis and epidural adhesions), and pain that ensues several years later as a sequele to alterations in spinal architecture and biomechanics (e.g., adjacent segment discogenic or facetogenic pain) which is called failed back surgery syndrome ( FBSS )

Detailed description

By observing adhesions directly, the lysis of scar tissue can be carried out mechanically using some percutaneous techniques as insertion of catheters as Rac'z catheter (thin in calibre) which will be inserted through the skin under fluoroscopy guidance or using NAVI catheter (large in calibre) either fluoroscopy guided or using thin epiduroscopy. Adhesions can be disintegrated and their evaluation scores may improve.

Conditions

• Failed Back Surgery Syndrome

Interventions

Type	Name	Description
PROCEDURE	Racz adhesolysis	adhesiolysis in failed back surgery
DEVICE	NAVI adhesolysis	adhesiolysis in failed back surgery

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-01
• Completion: 2023-08-13
• First posted: 2021-08-24
• Last updated: 2025-02-05

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study