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Device

CornerLoc SI Joint Stabilization Group for Sacroiliac Joint Dysfunction (COVI Trial)

N/A
Waitlist Available
Led By Michael Fishman, MD
Research Sponsored by CornerLoc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

COVI Trial Summary

This trial will compare the safety and effectiveness of a new device for stabilizing the SI joint to a steroid injection for treating SI joint dysfunction.

Eligible Conditions
  • Sacroiliac Joint Dysfunction

COVI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of sacroiliac joint stabilization using the CornerLoc procedure in the treatment of sacroiliac joint pain by evaluating the efficacy responder rate versus an intra-articular steroid injection.
Secondary outcome measures
Clinical improvement based on pain from baseline to each follow-up visit.
Clinical improvement based on use of medications from baseline to each follow-up visit.
Clinical improvement from baseline to each follow-up visit.
+3 more

COVI Trial Design

2Treatment groups
Active Control
Group I: CornerLoc SI Joint Stabilization GroupActive Control1 Intervention
Patient will receive the CornerLoc minimally invasive SI Joint Stabilization procedure. This procedure will be performed in an outpatient surgery center under local sedation or general anesthesia, and normally takes around 45 minutes. During the procedure, the physician will make two small incisions in the patient's lower back to access the SI joint, and place four small cadaveric bone grafts into the SI joint to help stabilize the SI joint.
Group II: SI Joint Steroid Injections GroupActive Control1 Intervention
Patient will receive an injection of steroid medication directly into their SI joint. The area around the SI joint will be numbed with an injection of local anesthetic and then ultrasound guidance will be used to guide the needle of steroid medication directly into the SI joint. This procedure will be performed in the physician's office or an outpatient surgery center, and normally takes around 30 minutes.

Find a Location

Who is running the clinical trial?

CornerLocLead Sponsor
1 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Sacroiliac Joint Dysfunction
240 Patients Enrolled for Sacroiliac Joint Dysfunction
Michael Fishman, MDPrincipal InvestigatorCenter for Interventional Pain & Spine
3 Previous Clinical Trials
770 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project open to new participants?

"Per the information on clinicaltrials.gov, recruitment for this particular trial has been ceased since March 7th 2022; it had first gone online in August 13th 2020. Nevertheless, there are currently 134 other trials that are actively seeking participants at present time."

Answered by AI
~1 spots leftby Apr 2025