Recruiting

Observational Study

Sponsor:

Spinal Simplicity LLC

Code:

NCT07204288

Conditions

Fusion of Spine

Sacroiliac; Fusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cat Scan, if applicable

Study Details

Brief summary:

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

Conditions

Fusion of Spine

Sacroiliac; Fusion

Study ID

NCT07204288

Start date

Sep 11, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be 18 years of age or older at the time of enrollment
2. Be willing and able to provide informed consent and comply with study visit requirements
3. Subjects who received a Spinal Simplicity fusion implant(s) (Minuteman G5, Liberty, and/or Patriot) between April 1, 2022 and March 31, 2025

Exclusion Criteria:

1. Unable to provide consent and complete prospective data collection
2. Women who are pregnant, or may become pregnant, during the course of the study
3. Contraindication to CT scanning, in the opinion of the investigator

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Previously implanted with lumbar and/or sacroiliac fusion device(s)

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.

Interventions

Cat Scan, if applicable

CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.

Primary outcome measure

  • Investigate radiographic outcomes [ Time Frame: Enrollment ]

Central Contacts and Locations

Central contacts

Echo Cundiff

9134514414ecundiff@spinalsimplicity.com

Adam Rogers

9134514414arogers@spinalsimplicity.com

Locations

Crimson Pain Management

Recruiting

Overland Park, Kansas, United States, 66209

Principal Investigator:

Daniel Kloster, MD

Nuroscience Research Center

Recruiting

Overland Park, Kansas, United States, 66210

Principal Investigator:

Mayank Gupta, MD

Nura Precision Pain Management

Recruiting

Edina, Minnesota, United States, 55435

Principal Investigator:

R. Scott Stayner, MD

More Information

Sponsor

Spinal Simplicity LLC

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spinal Simplicity LLC on 2026-03-18.