Clinical trials

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications). This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.

Prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an FFP type fracture equal to or higher than type II, according to Rommens and Hofmann. Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).

Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine. At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body. This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure

This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty. A registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.

The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System. A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation. Outcomes will be collected until up to 2 years after surgery.

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.

Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group. Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

Adult patients with cervical degenerative diseases undergoing primary anterior and/or posterior cervical fusion will be prospectively enrolled from participating sites. Patients will be treated and followed up at the participating sites per local standard of care. Several variables related to the patient characteristics and fusion details will be collected. The mainstream study will not collect follow-up (FU) data. The duration of this patient cohort is currently planned as open ended.

Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment. Pain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.

Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients' smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care. The primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability. All adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device. All patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months. The results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.