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Enrolling By Invitation
NCT05712850
Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
Conditions: Degenerative Sacroiliitis, Inflammatory Sacroiliitis, Iatrogenic Instability, Osteitis Condensans Ilii, Pelvic Fracture
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Enrollment: 25
Sponsor: VG Innovations, LLC
Location: United States
Summary
The purpose of this clinical study is to evaluate fusion of the SI joint(s) and any reduction in VAS pain scores in a prospective cohort of patients utilizing the SiJoin® Transfixing Sacroiliac Fusion Device in patients that received sacroiliac fusion, without ancillary stabilization devices.
Eligibility Criteria
Inclusion Criteria:Have provided consent for research by signing the Information and Consent for research form;Have given appropriate operative consent for a sacroiliac joint fixation procedure as standard of care using the SiJoin® Transfixing Sacroiliac Fusion Device;Are skeletally mature male or female, and are at least 18 years of age at time of surgery;Patient history confirms sacroiliac joint disfunction;Failure of six months of conservative care;Failure of NSAIDs;Positive diagnosis injection of sacroiliac joint; andAgree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation.Exclusion Criteria:Previous surgery or prior hardware in place at the target sacroiliac joint;Deidentified data cannot be provided;If female, pregnant at time of sacroiliac joint surgery;Found to be inappropriate candidate for sacroiliac joint fixation;Requires additional and/or other surgical technique and/or approach to the sacroiliac joint, which may in the opinion of the Primary Investigator confound measurement of outcome variables;Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis;Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery;Has active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the Investigator may increase patient risk or confound fusion results;Has BMI >40%;Has history of tobacco smoking within 6 months prior to operation;Has history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study;Has history of diabetes;Are participating in any other clinical trial;Patient is an employee (or family members of employees) of the PI/site or Sponsor; orPatient is limited or non-reader (e.g., blind, illiterate)
Source: ClinicalTrials.gov (NCT05712850). StuddyBuddy aggregates publicly available trial information.
