View clinical trials related to Intervertebral Disc Degeneration.
Filter by:The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the VariLift device. Potential treatment procedures include bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be performed in either an inpatient or outpatient facility. It is anticipated that the VariLift devices will improve patient outcomes and lead to the development of treatment pathways to improve patient care.
The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.
The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints. This study will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3 months prior to the initiation of this study. Given that fusion generally takes at least 6 months to determine, the aim of this study is not to determine fusion but to consider the short-term (out to 6 months) reported adverse events between the two cohorts. Devices used in both systems are cleared for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing. Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA). A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs. The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD). The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective, randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing Practice (GMP)-compliant expanded bone marrow MSC (MSV, Investigational medicinal product Num. 10-134). The assay consists of two arms with 12 patients each one. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated).
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months. Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process. nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes