Spinal Fusion Study

(FUSION Trial)

Recruiting at 2 trial locations

Overseen By Adam Rogers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spinal Simplicity LLC

Disqualifiers: Pregnancy, CT scan contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a multi-center, observational, prospective and retrospective data collection study

Who Is on the Research Team?

Tom Hedman, PhD

Principal Investigator

Spinal Simplicity LLC

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a Spinal Simplicity fusion implant (Minuteman G5, Liberty, Patriot) between April 2022 and March 2025. Participants must be able to give consent and follow study procedures. Pregnant women or those who may become pregnant are excluded, as well as anyone unable to undergo a CT scan.

Inclusion Criteria

Be willing and able to provide informed consent and comply with study visit requirements

Subjects who received a Spinal Simplicity fusion implant(s) (Minuteman G5, Liberty, and/or Patriot) between April 1, 2022 and March 31, 2025

I am 18 years old or older.

Exclusion Criteria

Women who are pregnant, or may become pregnant, during the course of the study

Contraindication to CT scanning, in the opinion of the investigator

I cannot give consent or provide data for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Collection and analysis of data from patients previously implanted with fusion devices

Not specified

Prospective Data Collection

Ongoing collection and analysis of patient-reported outcomes and radiographic outcomes

Not specified

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LUMBAR & SACROILIAC FUSION STUDY

Trial Overview The study observes outcomes in patients who've received spinal fusion implants by collecting data both before and after the surgery. It's not testing a new treatment but rather gathering information on how effective current treatments are over time.

How Is the Trial Designed?

Group I: Previously implanted with lumbar and/or sacroiliac fusion device(s) Experimental Treatment 1 Intervention

This study will involve patients previously commercially implanted with Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. Subjects will undergo a CT scan, if applicable and PROs.

Who Is Running the Clinical Trial?

Spinal Simplicity LLC

Lead Sponsor

Trials

2

Recruited

200+