Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Sacroiliac Joint Dysfunction Clinical Trial

Official title:

Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02074761
• Other study ID #: CLP 007-002
• Status: Active, not recruiting
• Start date: January 6, 2015
• Est. completion date: November 2020

Study information

• Verified date: October 2020
• Source: Surgalign Spine Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: November 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• At least three positive provocative tests for SIJ pain

• Non-operative management of SIJ pain for = 6 months prior to surgery

• At least one positive diagnostic SIJ injection resulting in a = 50% decrease in pain

• VAS back pain score of = 60 mm

• The subject is at least 18 years of age

Key Exclusion Criteria:

• Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit, or pelvic soft tissue or bony tumors

• Pregnant or is planning on becoming pregnant in the next two years

• Chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview.

• Receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain

• History of significant emotional or psychosocial disturbance

Related Conditions & MeSH terms

• Ankylosis
• Joint Diseases
• Sacroiliac Joint Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Tristate Brain and Spine Institute	Alexandria	Minnesota
United States	Bellevue Bone and Joint Physicians	Bellevue	Washington
United States	Fourth Corner Neurological Associates	Bellingham	Washington
United States	Regional Brain and Spine	Cape Girardeau	Missouri
United States	Medical University of South Carolina	Charleston	South Carolina
United States	DK Orthopaedics	Crown Point	Indiana
United States	Orthopaedic Clinic of Daytona Beach	Daytona Beach	Florida
United States	Essentia Health	Duluth	Minnesota
United States	SBA Medical Center	El Dorado	Kansas
United States	Gainesville Physical Therapy	Gainesville	Georgia
United States	Western Michigan University Homer Stryker MD School of Medicine	Kalamazoo	Michigan
United States	Rocky Mountain Spine Clinic	Lone Tree	Colorado
United States	BASIC Spine	Newport Beach	California
United States	Kaiser Permanente	Oakland	California
United States	Central Florida Neurosurgery Institute	Orlando	Florida
United States	The CORE Institute	Phoenix	Arizona
United States	Portland Pain and Spine	Portland	Oregon
United States	Black Hills Orthopedic & Spine Center	Rapid City	South Dakota
United States	Flagler Hospital	Saint Augustine	Florida
United States	University of Utah	Salt Lake City	Utah
United States	Northwest Orthopaedic Specialists	Spokane	Washington
United States	Azalea Orthopedics	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Surgalign Spine Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SI Joint Fusion	Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory	12 months
Primary	SI Joint Pain Reduction	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.	6 Months
Secondary	SI Joint Pain Reduction	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.	12 months
Secondary	Disability	Functional ability as determined by the Oswestry Disability Index	6 months
Secondary	Quality of Life	Quality of life as determined by EQ-5D	6 months