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Sacral Fracture Surgery for Rapid Rehabilitation (SAFFRON Trial)

N/A

Recruiting

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 is either bedbound or must use a wheelchair to cover distances more than 50ft

Prior to fracture, patient was able to ambulate using a cane or unassisted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

SAFFRON Trial Summary

This trial is comparing two treatments for patients with fractures in their sacral bones: surgical fixation and fusion of the sacral bones and joints, or non-surgical management. The trial will assess the safety and effectiveness of the surgical option.

Who is the study for?

This trial is for people over 60 who have a sacral fracture, are stable enough for treatment, and can follow the study plan. They must be bedbound or need a wheelchair for distances over 50ft due to pelvic pain from the fracture. Excluded are those with drug abuse issues, certain mental health conditions, other major fractures or infections, neurological problems that affect mobility, or allergies to titanium.Check my eligibility

What is being tested?

The study compares two approaches: surgery involving sacral fracture fixation and SI joint fusion versus non-surgical management. The goal is to see which method is safer and more effective in helping patients recover their ability to move around after suffering from fragile bone fractures.See study design

What are the potential side effects?

Potential side effects of surgical intervention may include infection risk at the surgery site, nerve damage leading to pain or numbness, bleeding complications during operation, and reactions related to anesthesia. Non-surgical management generally has fewer risks but may result in less rapid rehabilitation.

SAFFRON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am bedbound or need a wheelchair for distances over 50ft.

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Before my fracture, I could walk on my own or with a cane.

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I am medically fit for surgery or non-surgical treatment for my fracture.

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I am 60 years old or older.

SAFFRON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects with serious adverse event (SAE) probably or definitely related to a complication of sacral fracture and/or associated treatment (both arms) or probably or definitely related to iFuse-TORQ (surgery only).

Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).

Secondary outcome measures

Continuous Summary Physical Performance Score (CSPPS)

Numeric Rating Scale pain score

Oswestry Disability Index

+1 more

SAFFRON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgical TreatmentExperimental Treatment1 Intervention

Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint

Group II: Non-Surgical TreatmentActive Control1 Intervention

Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

SI-BONE, Inc.Lead Sponsor

12 Previous Clinical Trials

1,770 Total Patients Enrolled

Robyn Capobianco, PhDStudy DirectorSI-BONE

5 Previous Clinical Trials

2,732 Total Patients Enrolled

Media Library

Surgical Intervention (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05426356 — N/A

Sacral Fracture Research Study Groups: Non-Surgical Treatment, Surgical Treatment

Sacral Fracture Clinical Trial 2023: Surgical Intervention Highlights & Side Effects. Trial Name: NCT05426356 — N/A

Surgical Intervention (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05426356 — N/A

Frequently Asked Questions

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

What key goals are researchers aiming to achieve with this study?

"According to the trial sponsor, SI-BONE, Inc., this clinical investigation seeks to measure its primary outcome over a one year period. This is the proportion of subjects with serious adverse events probably or definitely related to sacral fracture and/or associated treatment in both arms; or due to iFuse-TORQ (exclusive for surgery).Secondary objectives include changes in CSPPS scores at 6 weeks and 12 months, PROMIS physical function score from baseline after 6 weeks and shifts on pain scale between 0 (pain free) up 10 (maximal discomfort) during the same timeline."

Answered by AI

What is the maximum capacity of participants for this medical experiment?

"Affirmative. Information found on clinicaltrials.gov reveals that this experiment was posted to the website on September 18th 2022 and has been actively seeking participants since then with its most recent update being October 12th 2022. 120 individuals will participate in total, distributed across 4 different medical facilities."

Answered by AI

Are new participants still being accepted for this clinical trial?

"Affirmative. According to the clinicaltrials.gov page, the trial was first posted in September 18th 2022 and is still actively recruiting participants as of October 12th 2022. The study needs 120 patients from 4 different medical sites for completion."

Answered by AI

To what extent is this trial being conducted across multiple sites?

"This medical study is being operated from Orthopedic Associates of Reading in Wyomissing, Pennsylvania, TRIA Orthopedics Mpls MN located in Bloomington, Minnesota and Saint Barnabas Medical Center situated within Livingston, New jersey as well as 4 other centres of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

2022. "Sacral Fracture Fusion/Fixation for Rapid Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05426356.

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