UnknownNot Applicable

Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

United States250 participantsStarted 2015-01-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SI Joint Fusion

Timeframe: 12 months

SI Joint Pain Reduction

Timeframe: 6 Months

Trial details

NCT IDNCT02074761

SponsorSurgalign Spine Technologies

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-08

View on ClinicalTrials.gov More Sacroiliac Joint Dysfunction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.