Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpinal Simplicity LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Cat Scan, if applicable

    Other intervention

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Previously implanted with lumbar and/or sacroiliac fusion device(s)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Enrollment

Secondary outcomes

1

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.

Time frame
Enrollment
2

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.

Time frame
Enrollment
3

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.

Time frame
Enrollment
4

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.

Time frame
Enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.