Active clinical trials for "Spinal Diseases"

One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.

Autologous Platelet-Rich-Plasma (PRP) represents a regenerative therapy that has gained remarkable ground in the field of orthopaedics in recent years. PRP has been implemented for a plethora of musculoskeletal ailments, being associated with minor complications and noteworthy efficacy (Akeda et al., 2019). PRP has been depicted to contain a variety of growth factors crucial for regulation of cell proliferation and migration as well as extracellular matrix synthesis (Cheng et al., 2019). Furthermore, therapeutic effect of PRP administration is considered to be additionally exerted via its anti-inflammatory and immunoregulative properties, as it has been delineated to induce regional decrease of pro-inflammatory mediators at the injection site (Hirase et al., 2020). Lumbar Degenerative Disc Disease (DDD) and Facet Joint Syndrome (FJS) constitute chronic degenerative conditions of lumbar spine that have been associated with substantial morbidity and disability in recent years. Besides the noted progress in comprehension of these conditions' pathogenesis, available therapeutic modalities remain extremely limited and controversial, being not capable of altering the natural progress of underlying disease (Wu et al., 2016; Wu et al., 2017; Hirase et al., 2020). Autologous PRR has been recommended as a beneficial alternative instead of conventional treatment strategies for interventional management of lumbar DDD and FJS (Aufiero et al., 2015; Navani and Hames, 2015; Kirchner and Anitua, 2016; Levi et al., 2016; Tuakli-Wosornu et al., 2016; Wu et al., 2016; Akeda et al., 2017; Lutz GE, 2017; Wu et al., 2017; Cheng et al., 2019). Results of these studies indicated that intra-discal and intra-articular injection of PRP for DDD and FJS respectively is characterized by safety and satisfactory efficacy in reducing intensity of clinical manifestations, exerting also potentially regenerative effects. However, quality of available evidence is remarkably low, since in the overwhelming majority of these studies was a limited number of patients evaluated. Furthermore, determined follow-up intervals were not extended and, most importantly, patients were not majorly with rigorous clinical and radiologic criteria selected. Aim of this study is to investigate the precise effects of intradiscal and intra-articular injection of PRP in patients with early-stage lumbar DDD and FJS, as determined by particular radiologic classifications. The prospective design, the defined greater number of recruited individuals in pilot analysis as well as the comparatively greater follow-up underline the originality of our protocol.

Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only

This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries and/or disorders following the local medical standard of care. The clinical data generated from this study will support compliance to global regulatory requirements including but not limited to the European Medical Device Regulation (EU MDR) for the applicable devices.

The goal of this clinical trial is to see if the investigators can find a safer and quicker way to localize the correct spinal level before the start of thoracic spinal surgery. Currently, this localization is done with the help of spinal needles and fluoroscopy. There are some inherent issues with accuracy due to individual factors such as the type of operating table or the body habitus. The investigators want to know if the use of ultrasound to count ribs and mark the corresponding spinal level would be a quicker and possibly even more accurate than the use of fluoroscopy. Participants who will be approached for this study are those that have already consented to undergo thoracic spinal surgery. Once they have been consented for the study, they will undergo anesthesia as per normal and positioned prone for the intended surgery. At this juncture, the radiographers will be setting up to perform fluoroscopy to confirm the spinal level and for the surgeons to mark the skin. For the purposes of the study, the investigators will use the ultrasound to count the ribs and mark the corresponding spinal level. Participants will undergo fluoroscopy to mark the skin level as well. The investigators are studying to see if the ultrasound method is just as accurate as the traditional fluoroscopy method. The results will be binary and will be recorded. The study ends at this point and no further participation is required from the patient.

The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.

To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of a new ligamentous fixation technique (vertebropexy)

The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function. Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.

This study is a prospective, randomized, controlled, double-arm, non-inferiority study that will be carried out in China. It aims to compare two implant systems (the research group uses surface-modified composite coated orthopedic implants, and controls group using conventional orthopedic implants) safety and effectiveness. A total of 240 patients were recruited. The recruited patients are randomly divided into groups at a ratio of 1:1 to ensure that the distribution of patients in the treatment group and the control group is consistent. Patients will receive clinical follow-up in the 1, 3, 6, 9 and 12 months postoperatively. The main indicator for evaluation is the postoperative infection rate, and the secondary indicators include the SF-12 scoring scale, EQ-5D patient questionnaire score, fracture healing, malunion, nonunion incidence in the 12th month after surgery, and skin and soft tissue complications Symptom incidence rate. The follow-up data will be used to determine the main safety and effectiveness of the new surface modified composite coated orthopedic implant system.

This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.