Clinical Trials

Inclusion Criteria:

• Age 18-80 at the time of surgery.
• Male or female.
• Indicated for long-segment LSF:
  • Long segment in this study will be defined as UIV of L2 or higher with extension to the sacrum;
  • Indication will be determined by the treating surgeon, which may include but is not limited to: degenerative disease, deformity, neurogenic claudication, radiculopathy, instability, or trauma.
• Symptomatic SI disease, radiographic SI degenerative disease, or need for prophylactic/supplemental lumbopelvic fixation as determined by the treating surgeon.

Exclusion Criteria:

• Failure to meet inclusion criteria.
• Prior long-segment LSF extending to the sacrum/pelvis.
• Prior SIJF.
• Revision SIFJ.
• Age less than 18 or greater than 80.
• Patients who are pregnant, breast feeding, or plan to become pregnant in the next 3 years. Please reference section 1.5.
• Vulnerable patient (ie patient unable to provide their own consent, dementia, intellectual disability/delay).
• Patients who do not clear pre-operative medical examination.
• Pregnancy which prevents surgical intervention or during the follow-up period which prevents safe acquisition of radiographic follow-up.
• Patients who, either preoperatively or intraoperatively it is determined that the investigational device may not be safely placed due to anatomic or extraneous factors.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/20/23. Questions regarding updates should be directed to the study team contact.