Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multi-center, observational, prospective and retrospective data collection study
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously implanted with lumbar and/or sacroiliac fusion device(s) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cat Scan, if applicable | Other | CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| NRS/ Numeric Rating Scale | 1. 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Echo Cundiff | Contact | 9134514414 | ecundiff@spinalsimplicity.com | |
| Adam Rogers | Contact | 9134514414 | arogers@spinalsimplicity.com |
| Name | Affiliation | Role |
|---|---|---|
| Tom Hedman, PhD | Spinal Simplicity LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crimson Pain Management | Recruiting | Overland Park | Kansas | 66209 | United States |
Results will be published at the sponsor's discretion.
Not provided
Not provided
Not provided
Not provided
Not provided
This will involve patients previously commercially implanted with Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device.
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | Enrollment |
| Nuroscience Research Center | Recruiting | Overland Park | Kansas | 66210 | United States |
|
| Nura Precision Pain Management | Recruiting | Edina | Minnesota | 55435 | United States |
|