Clinical Research Directory

PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

Safety and Effectiveness of the HIT Reverse HRS

The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.

Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA

The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA). The main questions are: * Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA? * Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods? Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.

Clinical Outcomes of Primary Cementless Total Hip Arthroplasty Using the Collarless Actis Stem

This study looks at how well a hip replacement using the collarless Actis stem works over five years. Total hip replacement is a common operation for people whose hip joint has been damaged by arthritis, by loss of blood supply to the hip bone, or by a broken hip. During the operation, the damaged parts of the hip are replaced with artificial parts. The Actis stem is the part that is fitted into the thigh bone. It is designed to bond directly with the bone, without the use of bone cement. The Actis stem is already used in many countries, and early results have been good. However, almost all of those results come from Western patients, and most studies used a version of the stem that has a small collar. Very little is known about how the collarless version performs in Asian patients, who tend to be younger at the time of surgery and more often have the operation because of loss of blood supply to the hip bone. People aged 18 years or older who are already scheduled for a hip replacement at this hospital may take part. Everyone who takes part has the same operation, with the same set of artificial parts. No extra tests are done for research purposes. After surgery, participants return to the clinic at 6 weeks, 3 months, and 12 months, and then once a year until 5 years have passed. These are the same visits that patients would have anyway. At each visit, the study team checks for any problems with the new hip, takes routine X-rays, and asks participants to fill in questionnaires about their hip pain, their daily activities, and their overall health. The main question the study asks is how many participants have a problem with the new hip within five years, such as the hip coming out of place, an infection, a break in the bone around the implant, or the implant becoming loose.

Early Feasibility Study of Cartilage Defect Repair

Any patient aged 14 or older up to 64 years of age with hip disease, resulting in loss of articular cartilage integrity on the femoral head (e.g., femoroacetabular impingement or other structural deformity), has failed conservative care, and is a candidate for surgical intervention to treat.

Measured vs Navigated Techniques in Total Hip Arthroplasty

Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA). Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques. Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters. The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e. measured) intra-operative assessments with the post-operative reconstructions achieved.

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Changes in Postural Stability Following THA for OA

Total hip arthroplasty (THA) is a common surgery that eases pain, restores functional movement, and improves the overall quality of life in people with severe hip osteoarthritis (OA). Unfortunately, problems with postural stability, commonly known as balance, are still noticed in people even years after the surgery. These postural stability problems typically result in falls. The aim of the proposed study is to investigate how THA surgery affects a person's overall quality of life, both physically and psychologically, in terms of postural stability and balance confidence (self-efficacy) within the first three months after THA for osteoarthritis. This prospective cohort study will focus on people over 60 years old.

DEXA Bone Density Analysis of the CoreHip® Prosthesis System

The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.

Digitalization of Osteoarthritis Care

The overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. The primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement

The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.

MINIMA Stem With DELTA TT or DELTA ST-C Study

This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.

A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.

Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty

The aim of this study is to compare the effectiveness of Virtual Reality therapy (VR therapy), Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in older adults following hip or knee arthroplasty, focusing on reducing psychological stress and improving functional recovery.

G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities. The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent. Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.

Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA

Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI in patients with osteoarthritis undergoing primary THA. The study is designed as a cross-over, cluster randomized, non-inferiority trial. All Danish orthopedic surgery departments performing primary THA with the majority being within inclusion criteria will be involved: Based on national quality databases, two-year cohorts of approximately 20,000 primary THAs conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.

Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial

his study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best. Patients will be randomly assigned to receive either no dexamethasone, 4 mg, or 8 mg, in addition to standard anesthesia and a nerve block (PENG block). The main goal is to see how long patients go without needing additional pain medication after surgery. The study will also look at pain levels, use of opioid painkillers, nausea and vomiting, blood sugar levels, and possible side effects.

Prehabilitation in Older People Undergoing Total Hip Replacement

The goal of this clinical trial is to determine the effect of Resistance Exercise Training (RET)-based (p)rehabilitation versus usual care on skeletal muscle mass and function, as well as on underlying biological processes, in older adults undergoing elective Total Hip Replacement (THR) due to severe Osteoarthritis (OA). The main questions it aims to answer are: * What is the effects of RET-based (p)rehabilitation versus usual care to improve muscle mass and function in patients undergoing elective unilateral THR surgery for end-stage OA? * What is the potential of certain circulating biomarkers to predict the efficacy of the musculoskeletal system response to RET in patients with severe OA? Researchers will compare RET-based (p)rehabilitation versus usual care to see if RET works to increase skeletal muscle mass and function. Participants in the usual care group will undergo standard rehabilitation (12 weeks post-surgery), and participants in the (p)rehabilitation group will undergo RET-based full-body (p)rehabilitation (3x/week) for 2 weeks pre-surgery and 12 weeks post-surgery.

Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

The study aims to assess the adequacy of a set of clinical and laboratory investigations for identifying the osteosarcopenia status in patients undergoing a hip replacement for a fragility fracture of the femoral neck. The control group will consist of patients undergoing a hip replacement for osteoarthritis, as the decrease in muscle function and bone quality is less severe in this condition than in osteoporosis.

Rate of Allergic Contact Dermatitis and Cosmetic Outcomes

The patients from the Department of Orthopaedics Center for Joint Replacement will be asked to participate in the study. These patients will be randomized to one of three wound closure products, Sylke adhesive dressing, Exofin skin glue, or Suture Strip Plus. Participants will be asked to take a photograph of the incision 4 days after surgery to submit via MyChart for review by the WVU Department of Dermatology Team. All patients will be evaluated at their regular 2-week, 6-week, and 3-month post-operative visits where clinical photographs will be submitted for independent review by the WVU Department of Dermatology Team to assess outcomes.

Promoting Sleep to Alleviate Pain - Arthroplasty

PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.

Telerehabilitation for Hip and Knee Osteoarthritis

Digital health utilization in the form of telerehabilitation is a popular technology that is very little researched for musculoskeletal disorders particularly hip and knee osteoarthritis (OA). The progression of OA will lead to total hip or knee replacement surgery. As a consequence, the advancing aging population leads to an increased burden on the healthcare system due to rising osteoarthritis. That's why, we will conduct a randomized controlled trial to explore the effectiveness of telerehabilitation in hip and knee osteoarthritis. This study will recruit OA patients into control and experimental groups. The control group will receive a patient education while the experimental group will undergo remote exercise sessions. Both groups will receive one supervised session a week for 5 weeks. The pre- and post-outcome measures will be recorded for functional status of hip and knee, muscle strength, and range of motions of the lower extremity. This innovative study will evaluate the effectiveness of a telemedicine intervention applied to a clinical population in Taiwan. The use of telerehabilitation interventions aims to reduce treatment and transportation costs, as well as save time for patients with OA. This digital health approach also helps to alleviate the workload of physiotherapists and rehabilitation doctors in clinics. The findings from this study could broaden the scope for using remote digital technology to assist clinical patients in diverse settings, especially those with limited or no hospital access.

Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)

Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.