Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

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

Study Overview

• Status: Unknown
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Device: SImmetry

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • The Core Institute
  • California
    • Newport Beach, California, United States, 92660
      • BASIC Spine
    • Oakland, California, United States, 94611
      • Kaiser Permanente
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Spine Clinic
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Orthopaedic Clinic of Daytona Beach
    • Orlando, Florida, United States, 32801
      • Central Florida Neurosurgery Institute
    • Saint Augustine, Florida, United States, 32086
      • Flagler Hospital
  • Georgia
    • Gainesville, Georgia, United States, 30506
      • Gainesville Physical Therapy
  • Indiana
    • Crown Point, Indiana, United States, 46307
      • DK Orthopaedics
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • SBA Medical Center
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • Western Michigan University Homer Stryker Md School of Medicine
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Tristate Brain and Spine Institute
    • Duluth, Minnesota, United States, 55805
      • Essentia Health
  • Missouri
    • Cape Girardeau, Missouri, United States, 63701
      • Regional Brain and Spine
  • Oregon
    • Portland, Oregon, United States, 97229
      • Portland Pain and Spine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Black Hills Orthopedic & Spine Center
  • Texas
    • Tyler, Texas, United States, 75701
      • Azalea Orthopedics
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
  • Washington
    • Bellevue, Washington, United States, 98004
      • Bellevue Bone and Joint Physicians
    • Bellingham, Washington, United States, 98225
      • Fourth Corner Neurological Associates
    • Spokane, Washington, United States, 99208
      • Northwest Orthopaedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates for SIJ fusion.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SImmetry Implant; Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Disability	Functional ability as determined by the Oswestry Disability Index	6 months
Quality of Life	Quality of life as determined by EQ-5D	6 months

Collaborators and Investigators

• Sponsor: Surgalign Spine Technologies

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: SI joint; sacroiliac joint fusion; SIJ fusion; SIJ
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Ankylosis
• Other Study ID Numbers: CLP 007-002