Fracture;PelvisSAFFRONNCT05426356
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
A study testing Surgical Intervention and Non-Surgical Management in people with Fracture;Pelvis and Sacral Fracture, run by SI-BONE, Inc. at 7 sites in United States.
Trial summary
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion
- What is being tested?
- Surgical Intervention and Non-Surgical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Sep 2022to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 60 years of age at screening.
- Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
- Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
- 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
- Medically stable to undergo either surgical or non-surgical treatment of index fracture.
- Patient is willing and able to provide written informed consent
- Patient is mentally able to comply with study protocol requirements
Who cannot join
- Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
- Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
- Sacral fracture potentially or definitely related to tumor
- Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
- History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
- Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
Show all 13Show fewer
- Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
- Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)
- Known allergy to titanium or titanium alloys
- Current local or systemic infection that raises the risk of surgery.
- Known or suspected active drug or alcohol abuse, including opioids.
- Patient lives or plans to move more than 100 miles from the site during the course of the study.
- Current enrollment in another investigational clinical trial related to fractures or osteoporosis
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
University of Chicago
Chicago, Illinois, 60637
Bryan Health Medical Center
Lincoln, Nebraska, 68501
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Kadlec Clinic Northwest Orthopedic & Sports Medicine
Richland, Washington, 99352
Orthopedic Associates of Reading
Wyomissing, Pennsylvania, 19610
About this study
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
Read the detailed description
SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM.
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture, Insufficiency Fractures, Osteoporosis
- Being tested
- Surgical Intervention, Non-Surgical Management
- Keywords
- Elderly, Fragility fracture, Pelvic fracture fixation, SI Joint Fusion, Non-surgical management
- Medical subject headings
- Hip Fractures, Fractures, Stress, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical InterventionDevice
Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ
Non-Surgical ManagementOther
Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.
| Study group | Role | What they receive |
|---|---|---|
| Non-Surgical Treatment | Active comparator | Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF) Receives: Other: Non-Surgical Management |
| Surgical Treatment | Experimental | Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint Receives: Device: Surgical Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).
The study's primary efficacy endpoint is the time required to achieve an improvement from baseline (study entry) of 2 or more points on the Modified Functional Mobility scale. The scale is administered on a weekly basis following the initiation of treatment until achieving a 2-point improvement or the subject crosses over.
Measured: 1 year
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).
If randomized to surgery:
Proportion of subjects with either:
- Serious adverse event deemed probably or definitely related to iFuse-TORQ
- Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment
If randomized to NSM:
Proportion of subjects with:
- Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment
Measured: 1 year
Secondary outcomes (4)
Continuous Summary Physical Performance Score (CSPPS)
Change of CSPPS scores at 6 weeks and 12 months. Continuous Summary Physical Performance Score (CSPPS) is a scoring system based on the Short Physical Performance Battery (SPPB) that is optimized for use in the elderly.
Measured: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function
Change from baseline in self reported PROMIS physical function score at 6 weeks. This domain is scored between 1 (unable to do) and 5 (can be done without difficulty).
Measured: 6 weeks
Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index at 6 weeks. Calculated scores range from 0 (no disability) to 50 (completely disabled).
Measured: 6 weeks
Numeric Rating Scale pain score
Change from baseline in self reported Numeric Rating Scale pain score at 6 weeks. Pain scale ranges from 0 (pain free) to 10 (max pain).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start18 Sep 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Why it stopped: Enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture;PelvisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomized to sacral fracture fixation and SI joint fusion using iFuse-TORQ vs. non-surgical management (NSM). There is a crossover component for subjects who fail NSM.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Capobianco, PhD, Study director, SI-BONE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426356
- Sponsor's protocol ID
- 300900
- Acronym
- SAFFRON
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
- ClinicalTrials.gov ID
- NCT05426356
- Acronym / sponsor ID
- SAFFRON / 300900
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture, Insufficiency Fractures, Osteoporosis
- Keywords
- Elderly, Fragility fracture, Pelvic fracture fixation, SI Joint Fusion, Non-surgical management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulties
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
Detailed description
SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects are randomized to sacral fracture fixation and SI joint fusion using iFuse-TORQ vs. non-surgical management (NSM). There is a crossover component for subjects who fail NSM.
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical Treatment | Active comparator | Other: Non-Surgical ManagementNon-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF) |
| Surgical Treatment | Experimental | Device: Surgical InterventionSurgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 60 years of age at screening.
- Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
- Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
- 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
Key exclusion criteria (13 listed)
- Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
- Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
- Sacral fracture potentially or definitely related to tumor
- Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
- History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical InterventionSurgical sacral fracture fixation and SI joint fusion using iFuse-TORQ | Device | Surgical Treatment |
| Non-Surgical ManagementNon-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery. | Other | Non-Surgical Treatment |
Primary outcome
Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).
Time frame: 1 year
The study's primary efficacy endpoint is the time required to achieve an improvement from baseline (study entry) of 2 or more points on the Modified Functional Mobility scale. The scale is administered on a weekly basis following the initiation of treatment until achieving a 2-point improvement or the subject crosses over.
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 frame: 1 year
If randomized to surgery: Proportion of subjects with either: * Serious adverse event deemed probably or definitely related to iFuse-TORQ * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment If randomized to NSM: Proportion of subjects with: * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment
4 secondary outcomes
Continuous Summary Physical Performance Score (CSPPS)
Time frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function
Time frame: 6 weeks
Oswestry Disability Index
Time frame: 6 weeks
Numeric Rating Scale pain score
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Enrollment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Fracture;Pelvis
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Capobianco, PhD study director
SI-BONE
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Intervention and Non-Surgical Management in people with Fracture;Pelvis and Sacral Fracture, run by SI-BONE, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS). (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.