NCT02064322

SAIF: Sacroiliac Fusion Study

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Zyga Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.)

Conditions

• Sacroiliac Joint Dysfunction

Interventions

Type	Name	Description
DEVICE	SImmetry Implant	The SImmetry system is commercially available. The implanted devices consist of a range of thread-tapping cannulated implants designed to transfix the sacrum and ilim, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-02-17
• Last updated: 2016-03-31