Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpinal Simplicity LLC
About this trial
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication
Be willing and capable of giving written consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided
Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
Be 18 years of age or older at the time of enrollment
Disqualifiers
Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.
Patient physically unable to perform the Gait and/or Balance tests.
Current systemic infection or local infection increasing the risk of surgery
History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
Trial design
Design model
Single group
Treatments tested in this trial
Minuteman G5 Device
DeviceThe Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Surgical GroupOther 1 intervention
Trial outcomes
Primary outcomes
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
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.2
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
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.3
PROMIS 29 2.0
PROMIS-29 c2.0 is a set of standardized questions that measures 29 items across 7 domains of physical and mental health. PROMIS-29 profile assesses pain intensity using a single 0-10 numeric rating scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. And seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Each domain is scored on T-Score Scale ranging between 22.9- 81.6 with a mean of 50 and a standard deviation of 10.
Time frame
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.4
Assessment of Motion using BioMech Lab testing equipment
A Primary Objective of this study is to collect real-world functional outcomes assessment of motion following treatment with the market-released Spinal Simplicity Minuteman G5 Device using BioMech Lab equipment to record gait and balance. The BioMech Lab motion analytics system will assess gait and balance via sensors placed before physical testing.
Time frame
Baseline and 1-, 3- and 12-months post implantation.Secondary outcomes
1
Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan
The secondary objective is to assess spinal fusion at 12 months post-operative using a Fusion Assessment Scale provided by Spinal Simplicity based on review of Lumbar CT Scan.
Time frame
Collected at 12 months post implantation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov