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Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain

NCT03507049 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-07-11

No results posted yet for this study

Summary

Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.

Conditions

  • Sacroiliac Joint Somatic Dysfunction

Interventions

PROCEDURE

iFuse

ifuse will be implanted as described in section on the active comparator arm of the study.

PROCEDURE

sham group

sham surgery will be performed as desrcribed in section on sham comparator.

RADIATION

fMRI study

Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Thomas Johan Dr Kibsgård, PhD, MD · Oslo University Hospital

  • Paul Dr Gerdhem, PhD, MD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2022-05-25
Completion
2030-05-25

Countries

  • Norway
  • Sweden

Study Locations

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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 NCT03507049 on ClinicalTrials.gov