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Titanium Implants
Minimally Invasive SIJ Fusion for Sacroiliac Joint Dysfunction (SALLY Trial)
N/A
Waitlist Available
Research Sponsored by SI-BONE, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has block on any study targeted side with improvement in SI joint pain numeric rating scale (NRS) at 30 or 60 minutes of at least 50% after injection of local anesthetic into any affected SI joint with an immediate pre-block NRS of at least 5
Baseline (average over the last week) SI joint pain score of at least 50 on 0-100 mm visual analog scale on any side to be treated under the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Awards & highlights
SALLY Trial Summary
This trial is testing a new type of implant to fuse the sacroiliac joint, in the hopes that it will provide better pain relief than current methods.
Who is the study for?
Adults aged 21-70 with sacroiliac joint dysfunction, experiencing pain for over 6 months despite conservative care. Candidates must have insurance coverage for treatment, respond positively to a diagnostic block injection, and be physically and mentally able to follow the study protocol. Exclusions include alternative causes of SI joint dysfunction like tumors or fractures, metabolic bone diseases, substance abuse, pregnancy intentions within a year, disability litigation related to SI joint/back pain, severe psychiatric disorders or other major back/hip conditions.Check my eligibility
What is being tested?
The SALLY trial is testing the effectiveness of minimally invasive surgery using iFuse-3D titanium implants in patients with sacroiliac joint dysfunction. The goal is to see if this procedure helps alleviate pain and improves physical function by fusing the affected joints.See study design
What are the potential side effects?
Potential side effects may include reactions specific to surgery such as infection risk at the surgical site, inflammation around the implant area, allergic reaction to titanium (for those with known allergies), and complications related to bone growth or healing.
SALLY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain in the SI joint decreased by at least 50% after a numbing shot.
Select...
My average SI joint pain score over the last week is at least 50.
Select...
I am between 21 and 70 years old.
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I have pain in my SI joint confirmed by 3 different physical tests.
SALLY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Clinical Outcome: Disability due to low back pain
Primary Radiographic Outcome: Bone adherence
Secondary outcome measures
Adverse Bone Reactions
Bridging Bone
Clinically Significant Radiolucency
+7 moreSALLY Trial Design
2Treatment groups
Experimental Treatment
Group I: SIJ fusion with iFuse 3D with 6 mo CTExperimental Treatment1 Intervention
These subjects will get pelvic CT at 6 months post-operatively.
Group II: SIJ fusion with iFuse 3D with 12 mo CTExperimental Treatment1 Intervention
These subjects will get pelvic CT at 12 months post-operatively.
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Who is running the clinical trial?
SI-BONE, Inc.Lead Sponsor
12 Previous Clinical Trials
1,840 Total Patients Enrolled
1 Trials studying Sacroiliac Joint Dysfunction
110 Patients Enrolled for Sacroiliac Joint Dysfunction
Daniel J Cher, MDStudy DirectorSI-BONE, Inc.
1 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have a long-term rheumatic disease like rheumatoid arthritis or lupus.I have an infection that could make surgery risky.You have experienced a significant injury to your pelvis within the past year.I have a bone condition like osteomalacia.I have had SI joint pain for 6 months or more that hasn't improved with basic treatments.My doctor thinks I am a good candidate for surgery with the iFuse-3D Implant.I can pinpoint my back or hip pain with one finger.My pain in the SI joint decreased by at least 50% after a numbing shot.My average SI joint pain score over the last week is at least 50.I am mentally and physically able to follow the study's requirements.I am not taking medications that harm bone or tissue healing.I am between 21 and 70 years old.I am not willing to sign the opioid contract for the study.You are allergic to titanium or materials made with titanium.My insurance will cover SI joint treatment, or I will pay for it myself.My surgeon thinks my body shape makes surgery too risky.I was previously diagnosed with a tumor in my sacrum or ilium.You have a known or suspected problem with using drugs or alcohol.I have an unstable fracture in my lower back affecting the sacrum or ilium.I have been diagnosed with osteoporosis or have taken medication for it.I do not have an uncontrolled psychiatric condition that could affect my participation.I have severe back or hip pain not caused by my current condition.I have a condition or body shape that prevents iFuse-3D implant treatment.I have been diagnosed with or suspected to have fibromyalgia.My SI joint pain is not caused by inflammation, tumor, infection, or a recent fracture.I have pain in my SI joint confirmed by 3 different physical tests.Your initial Oswestry Disability Index (ODI) score is at least 30%, indicating significant disability.I have pain in both SI joints scoring 50 or more and I refuse bilateral treatment.I have had a bone break due to my cancer.I have been diagnosed with sacroiliac joint dysfunction due to disruption or degeneration.
Research Study Groups:
This trial has the following groups:- Group 1: SIJ fusion with iFuse 3D with 6 mo CT
- Group 2: SIJ fusion with iFuse 3D with 12 mo CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still being sought for this experiment?
"The clinicaltrials.gov page suggests that this research is no longer accepting patients; the original post date was October 3rd 2017, and it has not been updated since December 7th 2021. Still, 1 additional study currently recruiting participants exists."
Answered by AI
What is the primary intention of this clinical experiment?
"This clinical trial is evaluating disability due to lower-back pain over a 6 or 12 month period, in comparison with historical data from other studies. Secondary objectives include evaluation of bridging bone formation, SIJ (sacroiliac joint) pain reduction via Visual Analog Scale and opioid use decrease from baseline."
Answered by AI
Are participants of this medical study over the age of 30 able to take part?
"This study is enrolling those aged between 21 and 70."
Answered by AI
Is there room for me to join this scientific inquiry?
"This clinical trial requires 50 people aged 21-70 who are suffering from sacroiliac dysfunction. The primary prerequisites for participation include: a visual analog scale (VAS) score of at least fifty on either side, insurance coverage/responsibility to cover expenses, confirmation of pain near the posterior superior iliac spine with Fortin Finger Test, improvement in SI joint pain after injection of local anesthetic into any affected SI joint and blockage test results must show a minimum NRS reduction of 50%, ODI score no lower than 30%, consent form signed and mental capacity & physical ability to adhere to protocol regulations."
Answered by AI
In what regions is the research experiment being conducted?
"The University of Colorado Hospital in Aurora, CO, Memorial Orthopaedic Surgical Group in Long Beach, CA, and Clin Tech Center for Spine Health in Johnstown, FL are amongst the dozen clinical sites accepting patients into this trial."
Answered by AI
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