Fusion of SpineFUSIONNCT07204288
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
An observational study of Fusion of Spine and Sacroiliac; Fusion, run by Spinal Simplicity LLC at 7 sites in United States.
Trial summary
This study is a multi-center, observational, prospective and retrospective data collection study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fusion of Spine, Sacroiliac; Fusion
- How many people
- 500 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Sep 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. There is not an inter Subjects will undergo a CT scan, if applicable and PROs.
Who may be able to join
- Be 18 years of age or older at the time of enrollment
- 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
Who cannot join
- Unable to provide consent and complete prospective data collection
- Women who are pregnant, or may become pregnant, during the course of the study
- Contraindication to CT scanning, in the opinion of the investigator
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 4 recruiting
- Recruiting
Southern Oklahoma Pain Management
Ardmore, Oklahoma, 73401
Abbigail RC, 580-221-2022, aphelps@sokpain.com
Adam Savage, MD
- Recruiting
The Spine and Nerve Center
Charleston, West Virginia, 25301
Catherine RC, 304-347-6830, catherine.bowne@wvumedicine.org
Timothy Deer, MD
- Completed
Spine Institute of North America
East Windsor, New Jersey, 08520
- Recruiting
Nura Precision Pain Management
Edina, Minnesota, 55435
Ken Farmer
R. Scott Stayner, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kate RC, 913-588-9900, kcanova@kumc.edu
Usman Latif, MD
- Completed
Crimson Pain Management
Overland Park, Kansas, 66209
- Completed
Nuroscience Research Center
Overland Park, Kansas, 66210
About this study
Official title: Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
This study is a multi-center, observational, prospective and retrospective data collection study
Read the detailed description
The purpose of this study is to evaluate fusion outcomes and patient-reported outcomes for Spinal Simplicity's lumbar and/or sacroiliac fusion implants: the Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. This will involve identifying patients previously implanted with any of these devices and conducting both retrospective and prospective data collection/analysis.
- Conditions
- Fusion of Spine, Sacroiliac; Fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate radiographic outcomes
The primary endpoints include the rate of fusion, and the rate of complications or reoperations.
Fusion Scale:1) Radiographically evaluate the rate of fusion, as determined by a panel of independent radiologists per the below fusion assessment metrics: Lumbar fusion grading scale (Minuteman G5): 1- Definitely fused 2- Probably fused 3- Probably not fused 4- Definitely not fused;
Sacroiliac fusion assessment (Liberty, Patriot):
Device(s) will be evaluated for (i) the presence of bridging bone from ilium to sacrum; and (ii) any evidence of migration or loosening
Additionally, if Minuteman G5 subjects have an interbody fusion device, interbody fusion will be assessed using the Bridwell scale:
1- Definite fusion 2- Probable fusion 3- Intermediate fusion/possible motion 4- Pseudoarthrosis/no bony connection
Measured: Enrollment
Secondary outcomes (4)
NRS/ Numeric Rating Scale
- Pain (Overall, Back and Leg) using NRS/numeric rating scale Overall pain, as well as back pain when standing/walking and leg pain when standing will be assessed using a numeric rating scale (NRS). The NRS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Measured: Enrollment
ODI/ Oswestry Disability Index
Oswestry Disability Index (ODI) ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed bound.
Measured: Enrollment
PGIC/ Patient Global Impression of Change
The Patient Global Impression of Change (PGIC) PGIC is a standardized tool designed to assess a patient's self-reported perception of improvement or worsening in their health status over time. The PGIC consists of 1 question, using a 1 to 7 scale: 1-Very Much Improved to 7-Very much Worse.
Measured: Enrollment
Subject Satisfaction Survey
Subject Satisfaction Survey Subject Satisfaction Survey is made up of 8 questions designed to assess a patient's self-reported satisfaction or dissatisfaction on a Likert scale. The Likert scale consists of 8 questions individually scored on a 1 to 5 scale: With lower scores indicating higher satisfaction and higher scores indicating greater dissatisfaction.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start11 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of SpineStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinal Simplicity LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Hedman, PhD, Study chair, Spinal Simplicity LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204288
- Sponsor's protocol ID
- SSMMSI-2025-CIP
- Acronym
- FUSION
- Status last verified
- Nov 2026
- First submitted
- 24 Sep 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published at the sponsor's discretion.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
- ClinicalTrials.gov ID
- NCT07204288
- Acronym / sponsor ID
- FUSION / SSMMSI-2025-CIP
- Conditions
- Fusion of Spine, Sacroiliac; Fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Spinal Simplicity LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Oct 2025 (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.
This study is a multi-center, observational, prospective and retrospective data collection study
Detailed description
The purpose of this study is to evaluate fusion outcomes and patient-reported outcomes for Spinal Simplicity's lumbar and/or sacroiliac fusion implants: the Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. This will involve identifying patients previously implanted with any of these devices and conducting both retrospective and prospective data collection/analysis.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. There is not an inter Subjects will undergo a CT scan, if applicable and PROs.
Key inclusion criteria (3 listed)
- Be 18 years of age or older at the time of enrollment
- 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
Key exclusion criteria (3 listed)
- Unable to provide consent and complete prospective data collection
- Women who are pregnant, or may become pregnant, during the course of the study
- Contraindication to CT scanning, in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigate radiographic outcomes
Time frame: Enrollment
The primary endpoints include the rate of fusion, and the rate of complications or reoperations. Fusion Scale:1) Radiographically evaluate the rate of fusion, as determined by a panel of independent radiologists per the below fusion assessment metrics: Lumbar fusion grading scale (Minuteman G5): 1- Definitely fused 2- Probably fused 3- Probably not fused 4- Definitely not fused; Sacroiliac fusion assessment (Liberty, Patriot): Device(s) will be evaluated for (i) the presence of bridging bone from ilium to sacrum; and (ii) any evidence of migration or loosening Additionally, if Minuteman G5 subjects have an interbody fusion device, interbody fusion will be assessed using the Bridwell scale: 1- Definite fusion 2- Probable fusion 3- Intermediate fusion/possible motion 4- Pseudoarthrosis/no bony connection
4 secondary outcomes
NRS/ Numeric Rating Scale
Time frame: Enrollment
ODI/ Oswestry Disability Index
Time frame: Enrollment
PGIC/ Patient Global Impression of Change
Time frame: Enrollment
Subject Satisfaction Survey
Time frame: Enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Results will be published at the sponsor's discretion.
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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.
Tom Hedman, PhD study chair
Spinal Simplicity LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fusion of Spine and Sacroiliac; Fusion, run by Spinal Simplicity LLC 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Echo Cundiff (9134514414, ecundiff@spinalsimplicity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate radiographic outcomes (time frame: Enrollment). 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 5 Nov 2026.