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NCT06155409
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7). Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.
NCT02617563
The purpose of this study is * to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I). * To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar Interbody Fusion) are used in surgical practice and to describe long-term safety and effectiveness in a broad patient population of patients with degenerative lumbar disc disease .
NCT07168603
This is an open-label, single-center Phase I/II clinical trial investigating the safety and efficacy of autologous nucleus pulposus cells (aNPC) in patients with disc degeneration. Eligible participants are those assessed by the principal investigator to have disc herniation suitable for discectomy and confirmed disc degeneration. During the treatment period, participants will receive a single injection of autologous nucleus pulposus cells at a concentration of approximately 1×10⁶ viable cells/mL with a total volume not exceeding 3 mL. The injection will be guided by C-arm X-ray to ensure accurate placement into the degenerated central nucleus pulposus of the disc from which tissue was previously harvested. Participants will be followed for 12 months. Safety assessments will primarily include monitoring for inflammatory responses using ESR and CRP after cell injection, as well as recording any treatment-emergent adverse events (AEs). Efficacy will be evaluated using pain assessment and imaging outcomes, including lumbar X-ray and MRI reviewed independently by a radiologist. Additionally, patient-reported outcomes will assess quality of life improvements following treatment using the Visual Analogue Scale (VAS), Activities of Daily Living (ADLs), and the Oswestry Disability Index (ODI). Laboratory tests, including CBC/DC, BUN, creatinine, AST, and ALT, will also be conducted throughout the treatment and observation period to monitor participant safety.
NCT04759105
ACTIVE is a phase II B efficacy monocenter, prospective, randomized, controlled double blinded trial, in which intra-discal autologous adult BM-MSC therapy will be compared with sham treated controls. This trial will evaluate the efficacy of intradiscal injection of autologous BM-MSCs in workers affected by chronic low back pain (LBP) unresponsive to conventional therapy. The efficacy will be evaluated 12 months after the treatment in terms of pain relief (VAS, Visual Analog Scale), functionality (ODI, Oswestry Disability Index), quality of life (SF36, Short Form - 36) and work ability index (WAI).
NCT05648474
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.
NCT05098431
Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).
NCT03076658
A study of the skeletal structure and how the structure changes over time. The aim of the study is to evaluate the skeleton in 10 year increments to determine an understanding of the normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS) can be used to evaluate the whole body to see changes in the bone structure over time. Subjects will be asked to undertake one x-ray analysis of their whole body skeletal structure. There will be 25 male and 25 female subjects per decade. The averaging of the measured skeletal parameters will provide information on changes over time generating a standardized expectation of general changes in skeletal structure as participants age.
NCT02023372
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.