Clinical Research Directory

MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).

Alexis Retractor in Total Hip Arthroplasty

To determine if there is a difference in wound healing and surgical site infection (SSI) rates using the Alexis wound retractor vs. not using it in longitudinal direct anterior approach total hip arthroplasty.

Implant-Related Infections in Patients With Skeletal Sarcomas

The aim of this observational study is to gain knowledge on the microbial and immunological factors behind implant-related infections in patients with skeletal sarcoma. The main research question the project aims to answer is: • Are immunological factors more important than microbial factors in peri-prosthetic joint infections in orthopaedic oncology patients? Patients with skeletal sarcoma planned for primary surgery (tumour resection and replacement with a megaprosthesis) will be sampled intraoperatively to obtain a cross-section bone tissue slice at the resection margin, three soft tissue biopsies and joint fluid (if possible). Patients who develop a peri-prosthetic joint infection after their primary surgery will be sampled in a similar manner during revision surgery. An additional group of patients with periprosthetic joint infection of a hip or knee prosthesis due to osteoarthritis will be sampled during their revision surgery (bone biopsies, soft tissue biopsies and joint fluid, if possible). Blood samples will be taken from all patients pre-operatively for extensive biochemical and cellular analyses. Researchers will compare periprosthetic tissues before and after infection. Further, periprosthetic infected tissues in patients treated for skeletal sarcoma will be compared to periprosthetic infected tissues in patientens treated for osteoarthritis. This will be done to attempt to identify host and microbial mechanisms responsible for the increased infection rate in patients with a megaprosthesis due to skeletal sarcoma (infection incidence rate up to 30%) compared to patients with a hip or knee prosthesis due to osteoarthritis (infection incidence rate 1-2%).

Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

Evaluating XPERIENCE™ Advanced Surgical Irrigation

A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).

Onset PrevenTIon of Urinary Retention in Orthopaedic Nursing and Rehabilitation

Urinary retention (UR) is a common problem in older people undergoing hip surgery. Untreated UR can lead to bladder distention and a permanent damage of the bladder, which can cause both physical and psychical suffering as well as increased costs for society. Even if national and international practice guidelines are in place for handling UR within the health care system, many fail to comply with them. Compliance to clinical practice guidelines are improved if different professions and managers collaborate as a team. In OPTION (Onset PrevenTIon of urinary retention in Orthopedic Nursing and rehabilitation) the investigators will coach multi-professional local facilitator teams in knowledge translation and implementation of UR practice as well as investigate the effects of such evidence-based practice in orthopedic nursing and rehabilitation. Implementation of research-based knowledge in evidence-based practice within an organization is complex with several known interacting factors. In a health care system these factors can be the care context, knowledge (innovation) and how the organization facilitates such implementations. The implementation strategy of OPTION utilize established theories of facilitation of knowledge implementation considering evidence and context with focus on leadership. The intervention consists of seminars and systematic support for implementation of UR-guidelines OPTION combine studies of adherence to evidence based practice regarding UR for patients over 65 years old that has undergone hip surgery and the health economic aspects of it. OPTION also contribute with improvements and increased knowledge regarding strategies to implement evidence based health care that can be used in other areas than UR and hip surgeries.

MDR - PMCF Study for Taperloc Complete Stems

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Patient Centered Post-Op Pain Management Software Tool Interventional Study Verses Standard of Care

The goal of this clinical trial is to learn if the Pain Coach App will result in less opioids being prescribed to and used by patients undergoing Shoulder/Hip/Knee Arthroplasty surgery while maintaining the same or better pain control versus standard of care. The main questions it aims to answer are: 1. Will elective shoulder, hip and knee arthroplasty patients using PainCoach App be prescribed and/or use less opioids, measured by total morphine milliequivalents (MME) after surgery when compared to those treated as standard of care while maintaining similar pain control? 2. Will arthroplasty surgeons using PainCoach App write more patient-specific prescriptions resulting in a reduction in opioids prescribed after surgery with no increase in further opioids prescribed in the months following surgery? 3. Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery? 4. Will patients and surgeons using PainCoach App find it helpful enough to use it again and recommend to colleagues, family and friends? Researchers will compare participants assigned to use Pain Coach App vs participants assigned to standard of care arm to see if there are differences in opioid prescriptions and self reported use. Participants will either use the Pain Coach App or follow standard of care instructions and be followed forward for the opioid prescriptions dispensed in community and self-reported opioids use at study end.

QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

The ARC Study is a national observational cohort study to investigate patient reported and clinical outcomes after hip and knee replacements. The study has the following objectives: 1. To evaluate outcomes following hip and knee replacements. 2. To determine risk factors for adverse outcomes in primary hip and knee replacements. 3. To identify targets for future research and intervention in patients undergoing primary hip and knee replacements 4. To provide a resource from which to identify potential participants for future clinical trials, and to use data collected in the ARC Study as comparison or control data for trial participants who have been randomised to receive one or more interventions. Participants are recruited and consented online. Patients are invited to participate by collaborating surgical teams nationally in outpatient clinics at the time of being added to a waiting list, in addition to an advertising campaign to recruit patients. They are directed to an online portal where they will be able to review further information. Consent and data collection is completed electronically through patients entering data online. Baseline demographics and characteristics are recorded, including details of socio-demographics, lifestyle, health status and patient reported outcome measures (PROMs). Patients then undergo hip/knee replacement and postoperative rehabilitation according to the standard care and protocols of the hospital and the preferences of their treating surgeon. Follow-up data, including PROMs, is collected via online questionnaires up to two years following surgery. The study will ultimately also enable multiple trials to be embedded within the cohort study, using a 'Trials within Cohorts' (TwiCs) methodology.

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.

Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.

The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study

Many individuals with osteoarthritis (OA) (up to 45%) are referred to an orthopaedic surgeon for a joint replacement prematurely or will not be candidates for surgery. These individuals need appropriate (non-operative) care to help reduce their pain and enhance their mobility. We are studying the use of innovative technology to help physicians give physical activity advice for patients to become more active and provide free online resources to help patients understand OA self-management and exercise, especially when they have barriers to accessing formal care. Individuals with OA that are referred to a specialized clinic will receive one of three interventions: usual care (handout on resources), a physical activity prescription by a doctor, or the prescription and a link to a free web-based platform (website) on non-operative management of OA with patient education and exercise videos. Our goal is to help with non-operative management strategies to improve quality of life, reduce pain, improve mobility, and possibly delay or prevent a joint replacement. Osteoarthritis is a condition where people feel joint pain or stiffness. Joints are the body parts where two bones join together with softer material (cartilage) between them. In osteoarthritis, this cartilage wears down. It is the biggest cause for disability worldwide. Helping people with osteoarthritis starts with education, physical activity, and physiotherapy. Doctors can also prescribe braces, injections or medications. For severe osteoarthritis when nothing else helps, surgery can be done to replace the joint. Doctors often refer patients for surgery too soon. Skipping steps of care may mean unnecessary surgery and longer wait times. The Musculoskeletal Rapid Access Clinic (now called Clinic) in London was set up to solve these problems. They screen patients before referring them to a surgeon, and do not refer almost half of patients. Our goal is to support these patients with new ways to make their non-surgical treatment better. The first way is through physical activity 'prescription'. It works well for other chronic conditions and patients say it helps. We don't know how well it works for people with osteoarthritis. Most doctors have little time, training or experience for prescribing physical activity. Technology can make it easier for doctors and patients. We have designed a tool to help doctors prescribe physical activity and a smartphone app to track patient activity. We have also created a free website. This includes patient education, exercise videos, and virtual physiotherapy. This can be important for individuals who can't access in-person care.

Post Market Clinical Follow-up of EUROSTEM Femoral Stem

EUROSSTEM is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety