Newnan, GANCT06355791Now EnrollingIRB Ready

Degenerative Conditions of the Lumbar Spine Clinical Trial in Newnan, GA

Access cutting-edge degenerative conditions of the lumbar spine treatment through this clinical trial at a research site in Newnan. Study-provided care at no cost to qualified participants.

Sponsored by Spinal Simplicity LLC

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Expert Care in Newnan

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related degenerative conditions of the lumbar spine treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Newnan

    Convenient for GA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Newnan site if eligible
  4. 4Begin participation

About This Degenerative Conditions of the Lumbar Spine Study in Newnan

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.

Sponsor: Spinal Simplicity LLC

Who Can Participate

Inclusion Criteria

A subject must MEET ALL of the following inclusion criteria:
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
Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
Be willing and able to comply with study-related requirements, procedures and visits
Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
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

A subject must NOT MEET ANY of the following exclusion criteria:
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
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 subject in the opinion of the Investigator
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.
Vertebral osteoporosis or history of vertebral fracture
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.
Malformation or dysplasia of spinous process
Severe osteoporosis with T score \<-2.5 SD

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Newnan?

Yes, this clinical trial (NCT06355791) has an active research site in Newnan, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Degenerative Conditions of the Lumbar Spine Treatment Options in Newnan, GA

If you're searching for degenerative conditions of the lumbar spine treatment options in Newnan, GA, this clinical trial (NCT06355791) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Newnan research site is actively enrolling participants for this clinical trial. You'll receive care from experienced degenerative conditions of the lumbar spine specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all degenerative conditions of the lumbar spine clinical trials near you to find additional studies recruiting in your area.

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