View clinical trials related to Intervertebral Disc Degeneration.
Filter by:This is a post-market, prospective, randomized clinical investigation to evaluate the performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone Void Filler for the treatment of cervical disc disease. A secondary objective is to compare the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40 patients at one (1) site. After subjects have signed an informed consent, they will be randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF Device. Patients will complete the preoperative visit and examinations. Patients will be evaluated at discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12) months. Patients will be evaluated at twenty-four (24) months post-operatively if they have not demonstrated fusion at the 12 month time point.
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
Investigate the potential of tissue grafting that includes human mesenchymal stem cells in the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo and at the time of surgical reconstruction. Our hypothesis proposes that stabilization will help restore normal structure and function in the degenerative lumbar spine may decrease chronic low back pain associated with the biomechanical demise of the degenerative disk or facet and may improve the natural history of adjacent segment disease found after spinal surgery.
Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.
This trial pretends to validate for clinical use a bioengineered product composed of mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM), Valladolid (MSV, which have already been approved by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These two groups collaborate in the present project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial is based on positive results obtained in previous animal studies performed by the present multidisciplinary team. A phase I / II clinical trial with 10 patients suffering from bone cysts in the maxillofacial region is proposed. Autologous mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity filled with the protein matrix containing the mesenchymal cells. Follow up tests will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and computerized tomography scan.
This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability.
The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.