The Stability Study (STABILITY)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lumbar Spinal Stenosis; Spondylolisthesis
• Intervention / Treatment: Device: Minuteman G5

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgical Group; patient treated with interspinous fusion device for degenerative conditions of the lumbar spine	Device: Minuteman G5; The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months

Collaborators and Investigators

• Sponsor: Spinal Simplicity LLC
• Investigators: Principal Investigator: Usman Latif, MD, University of Kansas

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: PDPROJ-4-TP-001-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients will be deidentified with unique study ID. Any study will be anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes