Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device

NCT05712850 | Unknown DMC

• 1 other identifier: VGI-004
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sacroiliitis; Sacroiliac Joint Dysfunction; Iatrogenic Injury; Osteitis Condensans Ilii; Pelvic Fracture

Outcome Measures

Primary Outcomes (2)

• Fusion Status/Evaluation

  Evaluate the fusion status of SI Joints using CT scans with a grading system based on: 1. Complete fusion; or 2. No fusion.

  12 Months

• Visual Analog Scale (VAS) Reduction

  Scale: 0 (No Pain) - 10 (Worst Pain Possible) Composite endpoint of reduction from baseline in VAS back pain score by at least 2 points.

  2-3 weeks, 3 Months, 6 Months, 12 Months

Secondary Outcomes (3)

• Ease of Use

  12 months

• Adverse Avents

  12 months

• Subsequent Surgical Interventions

  12 months

Interventions

SiJoin® Transfixing Sacroiliac Fusion Device PROCEDURE

Sacroiliac Fusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been evaluated and found appropriate for SI joint fixation according to accepted medical standards, and have agreed to this surgical procedure will be considered for study enrollment. Only those patients judged by the surgeon (intra-operatively) to be suitable for SI joint fixation using the SiJoin® Transfixing Sacroiliac Fusion Device will be included in data collection. Study patients will be identified and recruited from outpatient facilities affiliated with investigative sites. For the purposes of enrollment, patients will only be considered evaluable study patients after they complete eligibility screening and sign the study Information and Consent for Research Form.

You may qualify if:

• 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; and
• Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation.

You may not qualify if:

• 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; or
• Patient is limited or non-reader (e.g., blind, illiterate)

Sponsors & Collaborators

• VG Innovations, LLC: lead

Study Sites (1)

Seaside Surgery Center

Naples, Florida, 34109, United States

Location

MeSH Terms

Conditions

Sacroiliitis; Hip Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: January 19, 2023
• Primary Completion: January 18, 2024
• Study Completion: March 31, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

US (1)