TerminatedNot Applicable

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Stopped: Enrollment difficulties

United States28 participantsStarted 2022-09-18

Plain-language 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

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥ 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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).

Timeframe: 1 year

Trial details

NCT IDNCT05426356

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-15

View on ClinicalTrials.gov More Fracture;Pelvis trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥ 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

What they're measuring

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

Timeframe: 1 year

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria