NCT02074761

Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Surgalign Spine Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.

Detailed description

This is a prospective, non-randomized post market study designed to evaluate fusion and pain reduction following the use of the SImmetry System. This study will be conducted at up to 40 sites and 250 total subjects will be enrolled and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Conditions

• Sacroiliac Joint Dysfunction

Interventions

Type	Name	Description
DEVICE	SImmetry	The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, 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: 2015-01-06
• Primary completion: 2019-08-01
• Completion: 2020-11-01
• First posted: 2014-02-28
• Last updated: 2020-10-12

Locations

22 sites across 1 country: United States