Clinical Research Directory

A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures

The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.

Chiropractor Delivered Virtual Intervention After Vertebral frActure

This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture. This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization. VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.

Spine Bone Cements Outcomes - Post Market Follow-up

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

Sickle Cell Disease (SCD) Bone Pain Study

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice

The aim of this study is to evaluate clinical effectiveness and cost-effectiveness after implementing a medically approved and commercially available AI support system for opportunistic vertebral fracture screening in CT examinations within an adapted fracture care pathway (integrated care process) in clinical routine. Data will be compared to historical data (same period the previous year). The main question it aims to answer is: Does opportunistic AI-supported vertebral fracture screening in CT examinations integrated to a fracture care pathway increase the numbers of diagnosed vertebral fractures compared to usual care? CT scans in the clinical routine care will be opportunistically screened for vertebral fractures by the AI for 4 months. All positive findings will be confirmed by a radiologist and triaged by the FLS (Fracture Liaison Service).

A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases

Vertebral fracture is a common clinically significant skeletal related event in cancer patients. Stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (QoL) and also the overall survival. The multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. To overcome these shortcomings, the METASTRA models (METASTRA-AI and METASTRA-VPH) and the decision support system (METASTRA-DSS) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). The prospective data collection and analysis will provide reliability and validity results on the performance of METASTRA tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice. The study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. Precision) in fracture risk stratification of the METASTRA-AI and METASTRA-VPH computational models and to determine the reliability of METASTRA-AI and METASTRA-VPH as well as human decision making process in patient stratification.

RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.

Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.

Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.

Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).

Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology

Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.

Study of the Prevalence of Osteo-metabolic Complications in Patients With Thyroid Cancer

This is a multicenter retrospective observational study aimed to evaluate the prevalence of osteo-metabolic complications in patients with thyroid cancer.

Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

This study aimed to compare teriparatide treatments and PVPs, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.