Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2025-09-11
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Cat Scan, if applicable
Cat Scan is being used to assess fusion in previously implanted population
Interventions
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Cat Scan, if applicable
Cat Scan is being used to assess fusion in previously implanted population
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Spinal Simplicity LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Hedman, PhD
Role: STUDY_CHAIR
Spinal Simplicity LLC
Locations
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Crimson Pain Management
Overland Park, Kansas, United States
Nuroscience Research Center
Overland Park, Kansas, United States
Nura Precision Pain Management
Edina, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Morteza Rabii, NP
Role: primary
Amy Reinert
Role: primary
Ken Farmer
Role: primary
Other Identifiers
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SSMMSI-2025-CIP
Identifier Type: -
Identifier Source: org_study_id
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