Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
1 other identifier
observational
250
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedStudy Start
First participant enrolled
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedOctober 12, 2020
October 1, 2020
4.6 years
February 26, 2014
October 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
SI Joint Pain Reduction
12 months
Disability
6 months
Quality of Life
6 months
Study Arms (1)
SImmetry Implant
Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.
Interventions
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.
Eligibility Criteria
Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates for SIJ fusion.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
The CORE Institute
Phoenix, Arizona, 85023, United States
BASIC Spine
Newport Beach, California, 92660, United States
Kaiser Permanente
Oakland, California, 94611, United States
Rocky Mountain Spine Clinic
Lone Tree, Colorado, 80124, United States
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, 32117, United States
Central Florida Neurosurgery Institute
Orlando, Florida, 32801, United States
Flagler Hospital
Saint Augustine, Florida, 32086, United States
Gainesville Physical Therapy
Gainesville, Georgia, 30506, United States
DK Orthopaedics
Crown Point, Indiana, 46307, United States
SBA Medical Center
El Dorado, Kansas, 67042, United States
Western Michigan University Homer Stryker MD School of Medicine
Kalamazoo, Michigan, 49008, United States
Tristate Brain and Spine Institute
Alexandria, Minnesota, 56308, United States
Essentia Health
Duluth, Minnesota, 55805, United States
Regional Brain and Spine
Cape Girardeau, Missouri, 63701, United States
Portland Pain and Spine
Portland, Oregon, 97229, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Black Hills Orthopedic & Spine Center
Rapid City, South Dakota, 57702, United States
Azalea Orthopedics
Tyler, Texas, 75701, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Bellevue Bone and Joint Physicians
Bellevue, Washington, 98004, United States
Fourth Corner Neurological Associates
Bellingham, Washington, 98225, United States
Northwest Orthopaedic Specialists
Spokane, Washington, 99208, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2014
First Posted
February 28, 2014
Study Start
January 6, 2015
Primary Completion
August 1, 2019
Study Completion
November 1, 2020
Last Updated
October 12, 2020
Record last verified: 2020-10