Expired Study
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Reno, Nevada 89503


Purpose:

The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.


Study summary:

This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.


Criteria:

Inclusion Criteria: - Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling - Subject has two (2) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's - Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation - The subject has two (2) diagnostic SIJ injection at least one (1) resulting in a ≥50% decrease in pain in the joint(s) from the anesthetic portion of the injection - The subject has VAS back pain score of ≥ 50 mm - The subject is at least 18 years of age and skeletally mature - The subject agrees and is able to comply with study requirements Exclusion Criteria: - Subjects contraindicated per the cleared labeling will be excluded from participation in the study - The subject has pelvic soft tissue or bony tumors - The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit - The subject has a history of a central nervous system (CNS) disorder(s) - The subject is indicated for or awaiting other spine surgery - The subject is pregnant or is planning on becoming pregnant in the next two years - The subject has uncontrolled insulin dependent diabetes mellitus (Type 1 Diabetes) - The subject has 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 - The subject is receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain - The subject has a history of significant emotional or psychosocial disturbance (untreated or uncontrolled anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview


Study is Available At:


Original ID:

1099


NCT ID:

NCT02560714


Secondary ID:


Study Acronym:


Brief Title:

SI Joint Fusion and Decortication Using the SImmetry System


Official Title:

SI Joint Fusion and Decortication Using the SImmetry System


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Zyga Technology, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

No additional enrollment


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

17


Enrollment Type:

Actual


Study Dates

Start Date:August 2015
Completion Date:December 2017
Completion Type:Actual
Primary Completion Date:December 2017
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 20, 2017
First Received Date:September 23, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:SI Joint Pain Reduction
Time Frame:24 Months
Safety Issues:False
Description:SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.
Outcome Type:Primary Outcome
Measure:SI Joint Pain Reduction
Time Frame:6 months
Safety Issues:False
Description:SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.
Outcome Type:Primary Outcome
Measure:SI Joint Fusion
Time Frame:24 months
Safety Issues:False
Description:Number of participants with radiographic evidence of fusion of the SI joint, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.

Study Interventions

Intervention Type:Device
Name:SImmetry Sacroiliac Fusion System
Description: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.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Zyga Technology, Inc.

Samples and Retentions

Study Population: Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and candidates for SIJ fusion.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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