Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpinal Simplicity LLC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Minuteman G5 Device
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov