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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02074761
Other study ID # CLP 007-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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