The Stability Study

Lumbar Spinal Stenosis Clinical Trial

— STABILITY  

Official title:

The Stability Study: Functional Motion Outcomes In Patients Treated With An Interspinous Fusion Device For Degenerative Conditions Of The Lumbar Spine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06355791
• Other study ID #: PDPROJ-4-TP-001-23
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Spinal Simplicity LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The studied indication is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.

The purpose of this study is to evaluate the effectiveness and safety of instrumented posterior arthrodesis using the 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.

Description:

For this study, gait and balance tests will be performed using BioMech Lab. BioMech Lab uses sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. BioMech Lab provides real-time feedback and reporting. This study evaluates whether BioMech Lab gait and balance tests provide additional objective actionable intelligence with higher granularity and accuracy for the clinicians, patients, Spinal Simplicity, and the medical community.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject must provide informed written consent prior to any study related procedure or assessment.

• A male or female 18 years of age and less than 80 years of age.

• Subject has received at least 3 months of non-operative or conservative treatment.

• Subject has received a recommendation from their care providing physician to receive a Spinal Simplicity Minuteman G5 Fusion Plate device to treat degenerative conditions of the lumbar spine in accordance with the device's FDA 510(k)-cleared ( K233527 indications.

Exclusion Criteria:

• Subject is unable to provide informed consent.

• 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

• Laminectomy at the level of the intervention (MILD procedure is not excluded)

• Spinal hardware at the level of the intervention

• Grade II-V spondylolisthesis

• Significant scoliosis with Cobb angle >10 degrees

• Unremitting back pain in a spinal flexion position

• Active systemic disease that may affect the welfare of the patient

• Subject is enrolled in, a clinical drug and/or device study that may alter or confound the results of the fusion 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. If the subject enrolls in a clinical drug trial after the surgical procedure that may alter or confound the results as determined by the investigator, the investigator will determine whether the patient should continue follow-up.

• Vertebral osteoporosis or history of vertebral fracture

• Pregnant or lactating female prior or during the surgical period and 3 months post-operatively.

• Malformation or dysplasia of spinous process

• Severe osteoporosis with T score <-2.5 SD

• Sensitivity to adhesive which would prevent application of BioMech sensors as determined by the investigator.

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• Minuteman G5
The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

Locations

Country	Name	City	State
United States	Kansas University Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Spinal Simplicity LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS Back and Leg	The Primary Objective of this study is to collect real-world functional outcomes on the safety and efficacy of the ambulatory use of the market-released Spinal Simplicity Minuteman G5 MIS Fusion Plate with bone graft material through assessing gait and stability outcomes pre- and post -operatively of all patients treated with the Spinal Simplicity Minuteman G5 MIS Fusion Plate. The numeric rating scale (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	three follow up points post-implantation of the Minuteman G5 Fusion Plate device: at baseline, 1 month, 3 months, 6 months and 12 months post-implantation.
Primary	ODI	The Primary Objective of this study is to collect real-world functional outcomes on the safety and efficacy of the ambulatory use of the market-released Spinal Simplicity Minuteman G5 MIS Fusion Plate with bone graft material through assessing gait and stability outcomes pre- and post -operatively of all patients treated with the Spinal Simplicity Minuteman G5 MIS Fusion Plate. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.	three follow up points post-implantation of the Minuteman G5 Fusion Plate device: at baseline, 1 month, 3 months, 6 months and 12 months post-implantation.
Primary	PROMIS 29 2.0	The Primary Objective of this study is to collect real-world functional outcomes on the safety and efficacy of the ambulatory use of the market-released Spinal Simplicity Minuteman G5 MIS Fusion Plate with bone graft material through assessing gait and stability outcomes pre- and post -operatively of all patients treated with the Spinal Simplicity Minuteman G5 MIS Fusion Plate. PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item 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.	three follow up points post-implantation of the Minuteman G5 Fusion Plate device: at baseline, 1 month, 3 months, 6 months and 12 months post-implantation.
Secondary	12 Month Fusion Assessment	The secondary objective is to randomly select a minimum of 25% of the patient enrollment population for assessment of spinal fusion at 12 months post-operative based on a Fusion Assessment Scale provided by Spinal Simplicity. This scale is attached as a PDF.	12 Months