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Fracture clinical trials

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NCT ID: NCT05292001 Recruiting - Fracture Clinical Trials

Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Acute blood loss in orthopaedic trauma and operative fracture care contributes substantially to perioperative anemia, which places participants at increased risk for complications including surgical site infection, cardiovascular complications, and even death. Anemia has further clinical implications in quality of life measures and is associated with fatigue, impaired physical performance, decreased exercise capacity, and mood disturbances. Thus, evaluation and treatment of perioperative anemia is critical in risk mitigation within orthopaedic surgery. The current standard of care for anemia is transfusion of packed red blood cells in only cases of severe anemia due to the substantial associated risks. A safer alternative is desirable because a critical number of participants do not meet the restrictive transfusion threshold and may suffer negative effects from anemia during recovery from the acute insult. The focus of this project is to pilot an investigation of the benefits of intravenous iron therapy (IVIT) in traumatically injured patients. Specifically, Aim I will determine feasibility of study design, recruitment, randomization, intervention implementation, blinded procedures, and retention. In Aim II, time to return to normal hemoglobin following traumatic orthopaedic injury will be assessed. With Aim III, the investigators will measure IVIT effect on participant-reported fatigue, physical function, and depression, and further determine if resolution of anemia is correlated to improvements in these measures in traumatically injured orthopaedic patients. Aim IV will focus on evaluating the role of IVIT on immune cells through a variety of novel laboratory assessments. The investigators expect this study to provide a better understanding of IVIT, which has the potential to alter providers' treatment approach of anemia in participants who sustain traumatic orthopaedic injury, thereby leading to decreased risks and improved recovery.

NCT ID: NCT05162521 Recruiting - Fracture Clinical Trials

The Impact of Lower Limb Fractures on Body Mass Index (BMI)

Start date: April 1, 2021
Phase:
Study type: Observational

The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury

NCT ID: NCT05002335 Recruiting - Avascular Necrosis Clinical Trials

Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

Start date: October 6, 2020
Phase:
Study type: Observational

This is a post-market surveillance study on Medacta Shoulder System

NCT ID: NCT04947722 Recruiting - Osteoporosis Clinical Trials

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

NCT ID: NCT04730739 Recruiting - Fracture Clinical Trials

FastFrame Knee Spanning and Damage Control Kit PMCF

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

NCT ID: NCT04355325 Recruiting - Fracture Clinical Trials

Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study

Start date: April 2, 2020
Phase: N/A
Study type: Interventional

The outcome of implant therapy has been presented in the majority of clinical studies by focusing only on implant survival without providing detailed information on the reconstructions . However, for decision making, it is important to know the survival rates and the incidence of biological and technical complications not only for the implants but also for the reconstructions. Thus, the selection of restoration materials should be based on proper optical characteristics in addition to biocompatibility and sufficient strength of materials. Monolithic zirconia has been used in posterior region, especially for single crowns, in order to eliminate the veneer cracking, But Since monolithic zirconia are relatively new, few randomized, controlled clinical studies have evaluated their success. There is only one study identified regarding the performance of monolithic ceramic restorations bonded to Ti inserts, investigating the clinical outcome of using monolithic or modified monolithic zirconia implant-supported single crowns and comparing outcomes and complications of metal-ceramic and monolithic or modified monolithic zirconia implant supported single crowns. More clinical studies to evaluate the performance of CAD/CAM monolithic implant-supported restorations bonded to Ti inserts and bases and compare their survival, success and complication rates with other restorative options [with a mean follow-up period of at least 5 years are required for a meaningful interpretation of the survival and complication rate . So this study aims to investigate outcomes and complications of implant supported modified monolithic zirconia and metal-ceramic single crowns in the posterior region of the mouth. The null hypothesis is that there is no difference between modified monolithic zirconia and metal-ceramic posterior implant-supported SCs in prosthetic complication rates.

NCT ID: NCT04195256 Recruiting - Fracture Clinical Trials

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

Ketodex
Start date: March 11, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).

NCT ID: NCT04133103 Recruiting - Fracture Clinical Trials

Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

Start date: October 16, 2019
Phase: N/A
Study type: Interventional

In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.

NCT ID: NCT03547947 Recruiting - Avascular Necrosis Clinical Trials

Clinical and Radiological Outcomes of Medacta Shoulder System

Start date: June 13, 2018
Phase:
Study type: Observational

This is a post-marketing surveillance on Medacta Shoulder System

NCT ID: NCT03219099 Recruiting - Osteoporosis Clinical Trials

Normative Database for HR-pQCT-Based Radius and Tibia Strength

NODARATIS
Start date: June 14, 2018
Phase:
Study type: Observational

A novel methodology was recently developed and validated by the applicants to compute bone strength at the distal radius and tibia using second-generation HR-pQCT reconstructions. The methodology is expected to improve significantly the assessment of bone fracture risk in idiopathic and secondary osteoporosis, but no reference data and no reproducibility data are available. The objective of the study is the determination of the sex- and age-specific distributions of accurate distal radius and tibia strength assessed by HR-pQCT in the Swiss population.