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Sacroiliac Joint Fusion Comparison Study

NCT03230279 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-08-22

No results posted yet for this study

Summary

Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or radiofrequency ablation. The radio frequency ablation is performed using either conventional or "cooled" techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at comparing treatment success at 6-month follow-up time-point after minimally invasive sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.

Conditions

  • Sacroiliac Joint Somatic Dysfunction
  • Sacroiliac; Spondylitis

Interventions

PROCEDURE

Sacroiliac joint fusion

Minimally invasive SIJ fusion will be performed under general anesthesia with fluoroscopy. Using SI-LOK®, Sacroiliac Joint Fixation System, Globus Medical Inc. (Audubon, PA), this procedure involve placement of 2 to 3 implants across the SIJ to achieve stabilization and arthrodesis.

PROCEDURE

Sacroiliac joint radiofrequency ablation

Sacroiliac joint radio frequency ablation will be performed using either conventional or cooled radiofrequency ablation techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. The choice between conventional or cooled RFN will be determined by the provider expertise.

Sponsors & Collaborators

  • Globus Medical Inc

    collaborator INDUSTRY

  • Ochsner Health System

    lead OTHER

Principal Investigators

  • Daniel R Denis, MD-MSc · Ochsner Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2023-09-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230279 on ClinicalTrials.gov