Clinical Trial Finder

The Stability Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06355791
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Spinal Simplicity LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Usman Latif, MD
Principal Investigator Affiliation University of Kansas
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lumbar Spinal Stenosis, Spondylolisthesis
Additional Details

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.

Arms & Interventions

Arms

Other: Surgical Group

patient treated with interspinous fusion device for degenerative conditions of the lumbar spine

Interventions

Device: - Minuteman G5

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Kansas University Medical Center, Kansas City, Kansas

Status

Address

Kansas University Medical Center

Kansas City, Kansas, 66160

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