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SAIF: Sacroiliac Fusion Study | Clinical Trials | Clareo Health

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SAIF: Sacroiliac Fusion Study

SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

NCT02064322•Zyga Technology, Inc.

Summary

The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.

Detailed Description

This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
•Subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
•Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
•The subject has one (1) positive diagnostic SIJ injection, resulting in a ≥50% decrease in pain from the anesthetic portion of the injection
•The subject has VAS back pain score of ≥ 60 mm
•The subject has an ODI ≥ 40%
•The subject is at least 18 years of age and skeletally mature
•The subject agrees and is able to comply with study requirements

Exclusion Criteria

•Subjects contraindicated per the cleared labeling will be excluded from participation in the study
•The subject has pelvic soft tissue or bony tumors
•The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
•The subject has a history of a central nervous system (CNS) disorder(s)
•The subject is pregnant or is planning on becoming pregnant in the next two years
•The subject has chemical dependency problems as evidenced by a history of drug abuse which is documented in their past medical history or is elicited from an interview
•The subject has a history of significant emotional or psychosocial disturbance (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview

Key Dates

Start Date

February 1, 2014

Primary Completion Date

March 1, 2016

Completion Date

March 1, 2016

Last Updated

March 31, 2016

Enrollment

ACTUAL participants

Conditions

Sacroiliac Joint Dysfunction

Interventions

SImmetry Implant

DEVICE

Modified Sims Versus Lumbar Roll Manipulation in Patients With Sacroiliac Joint Dysfunction

NCT07258537

Sacroiliac Joint Dysfunction

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Effect of K-Taping and Yoga Therapy in Postural Correction for Sacroiliac Jointamong Weightlifters

NCT07037173

Sacroiliac Joint Dysfunction

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Comparison of Diagnostic and Therapeutic Efficacy of Periarticular And/or Intraarticular Lidocaine Injections Under Ultrasound Guidance in Sacroiliac Joint Dysfunction

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SAIF: Sacroiliac Fusion Study

Inclusion Criteria

Exclusion Criteria

Modified Sims Versus Lumbar Roll Manipulation in Patients With Sacroiliac Joint Dysfunction

Effect of K-Taping and Yoga Therapy in Postural Correction for Sacroiliac Jointamong Weightlifters

Comparison of Diagnostic and Therapeutic Efficacy of Periarticular And/or Intraarticular Lidocaine Injections Under Ultrasound Guidance in Sacroiliac Joint Dysfunction

McKenzie and William Exercises in Patients With Sacroiliac Joint Dysfunction

Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction

Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device