Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
NCT ID: NCT06355791
Last Updated: 2025-10-03
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
150 participants
INTERVENTIONAL
2024-05-29
2030-12-31
Brief Summary
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Detailed Description
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Key outcome assessments will include gait and balance testing performed using BioMech Lab sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. Patient reported outcome measures will also be collected to evaluate pain, quality of life and satisfaction. During the primary assessment at 12-months post-treatment subject will be offered a computerized topography (CT) scan to evaluate spinal fusion.
After completion of the Month 12 visit all subjects will be asked to complete annual visits through 5 years, which include collection of PROMs, safety review, and can be completed in person or remote.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgical Group
patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine
Minuteman G5 Device
The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy
Interventions
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Minuteman G5 Device
The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
4. Be 18 years of age or older at the time of enrollment
5. Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
6. Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
7. Be willing and able to comply with study-related requirements, procedures and visits
8. Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
9. Must disclose any unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the Investigator. Including being involved in an injury claim under current litigation or has a pending or approved worker's compensation claim. Subjects will not be excluded due to secondary gain, but it should be disclosed at Enrollment.
Exclusion Criteria
2. Patient physically unable to perform the Gait and/or Balance tests.
3. Current systemic infection or local infection increasing the risk of surgery
4. History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
5. Grade II-V spondylolisthesis
6. Significant scoliosis with Cobb angle \>10 degrees
7. Unremitting back pain in a spinal flexion position
8. Active systemic disease that may affect the welfare of the subject in the opinion of the Investigator
9. Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) as determined by the investigator.
10. Vertebral osteoporosis or history of vertebral fracture
11. Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, subject must be willing to use a reliable form of birth control through the 3-month visit.
12. Malformation or dysplasia of spinous process
13. Severe osteoporosis with T score \<-2.5 SD
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
Locations
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Vista Clinical Research
Newnan, Georgia, United States
Comprehensive Pain & Spine Specialists
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Nura Precision Pain Management
Edina, Minnesota, United States
Pacific Sports & Spine
Eugene, Oregon, United States
Spine & Nerve Center of the Virginias
Charleston, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Debra Helton
Role: primary
Esther Owusu
Role: primary
Manuel Clark
Role: primary
Ken Farmer
Role: primary
Katie Fabian
Role: primary
Amy Young, RN-RC
Role: primary
Other Identifiers
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PDPROJ-4-TP-001-23
Identifier Type: -
Identifier Source: org_study_id
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