Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
NCT ID: NCT02074761
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2015-01-06
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SImmetry Implant
Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Surgalign Spine Technologies
INDUSTRY
Responsible Party
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Locations
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The CORE Institute
Phoenix, Arizona, United States
BASIC Spine
Newport Beach, California, United States
Kaiser Permanente
Oakland, California, United States
Rocky Mountain Spine Clinic
Lone Tree, Colorado, United States
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, United States
Central Florida Neurosurgery Institute
Orlando, Florida, United States
Flagler Hospital
Saint Augustine, Florida, United States
Gainesville Physical Therapy
Gainesville, Georgia, United States
DK Orthopaedics
Crown Point, Indiana, United States
SBA Medical Center
El Dorado, Kansas, United States
Western Michigan University Homer Stryker MD School of Medicine
Kalamazoo, Michigan, United States
Tristate Brain and Spine Institute
Alexandria, Minnesota, United States
Essentia Health
Duluth, Minnesota, United States
Regional Brain and Spine
Cape Girardeau, Missouri, United States
Portland Pain and Spine
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Black Hills Orthopedic & Spine Center
Rapid City, South Dakota, United States
Azalea Orthopedics
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Bellevue Bone and Joint Physicians
Bellevue, Washington, United States
Fourth Corner Neurological Associates
Bellingham, Washington, United States
Northwest Orthopaedic Specialists
Spokane, Washington, United States
Countries
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Other Identifiers
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CLP 007-002
Identifier Type: -
Identifier Source: org_study_id
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