Joint Replacement / Arthroplasty

Researchers are evaluating the use of Synolis VA 80/160, a device containing hyaluronic acid and sorbitol, in adults with hip osteoarthritis. This study aims to assess the effectiveness and safety of this treatment over a 6-month period in patients experiencing symptoms related to this condition who have not responded well to standard pain relief treatments. The study is conducted independently across multiple centers. Participants will receive a single guided injection of Synolis VA 80/160 directly into the affected hip joint. The study monitors changes in hip function and pain using the Oxford Hip Score at various points including 3 and 6 months after injection. Additional evaluations include patient self-assessments of symptom evolution and tracking whether participants require hip prosthesis placement within 6 months. During the study, participants will undergo assessments at baseline and follow-up visits where their hip function and symptoms are measured using standard questionnaires. The main outcome is the evolution of the Oxford Hip Score after 6 months. Researchers will also monitor safety and any need for hip replacement surgery. Participants will be involved for the full 6-month study duration, with data collected to understand both short-term and longer-term effects of the treatment.

This research aims to compare myoelectric and bionic prosthetic hands to understand differences in upper limb function, body image, and user satisfaction among individuals with upper limb amputations. It focuses on answering whether the functional abilities differ between these two types of prosthetic devices used by people with amputations. The study is observational and involves adults aged 18 to 65 who regularly use prosthetic hands. Participants will either use advanced bionic prosthetic hands featuring multi-articulating structures and enhanced control systems designed to improve function and dexterity or myoelectric prosthetic hands controlled by muscle signals from the residual limb that provide basic powered hand movements. These groups allow comparison of the newer bionic technology against conventional myoelectric devices. During the study, participants will complete assessments including the Upper Limb Functional Index-15, Amputee Body Image Scale, and Orthotics and Prosthetics Users' Survey at baseline. These measures will help evaluate hand function, body image perception, and satisfaction with prosthetic use. The study is led by Gulhane School of Medicine and participation spans from November 2025 to March 2026, involving adults with unilateral upper limb amputation who have been using prostheses for at least six months.

This research aims to compare how well two diagnostic methods—percutaneous aspiration and open biopsy—detect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection (PJI) is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.

Researchers are studying participants with early or acute hematogenous periprosthetic joint infection (PJI) following total knee arthroplasty (TKA) or other joint replacement surgeries. The study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of TNP-2092 given by intra-articular (IA) injection alongside vancomycin intravenous (IV) and oral antibiotics. This Phase 1/2, randomized, controlled, open-label study explores treatment options for PJI patients requiring or not requiring debridement, antibiotics, and implant retention (DAIR) therapy or long-term antibiotic suppression. Participants are assigned to one of four groups: a sentinel group receiving TNP-2092 IA plus vancomycin IV and oral antibiotics, an experimental group receiving the same, a control group receiving vancomycin IA plus vancomycin IV and oral antibiotics, or an expansion group receiving TNP-2092 IA based on background treatment. TNP-2092 is administered at 50 mg via IA injection once daily for 14 days, with dose adjustments allowed based on drug concentrations and safety. Oral antibiotic treatment lasts 8 weeks, and vancomycin IV and IA are given daily for 14 days. Participants undergo screening assessments within 7 days before starting the study and must agree to hospitalization for 2 weeks of IA injections. Researchers will monitor safety by tracking adverse events through Day 187 and measure TNP-2092 concentrations in synovial fluid and plasma at multiple time points. They will also assess treatment responses at Day 14 and study end, along with treatment failure within 6 months. The study involves regular blood tests and clinical evaluations to evaluate the treatment's pharmacokinetics and local and systemic effects.

Researchers are studying the long-term performance of the Mpact 3D Metal MonoCER cup used in total hip arthroplasty for patients under 75 years old. This observational study aims to assess how well the implant lasts and functions over a period of 10 years after the surgery. The study focuses on patients receiving this specific metal cup as part of their hip replacement. Participants will receive the Mpact 3D Metal cup as an acetabular shell device during their total hip arthroplasty surgery. The study follows standard treatment practices, and patients who choose not to participate will receive the same care. Follow-up visits are scheduled at 6 months, 1 year, 5 years, and 10 years after surgery to monitor outcomes. During these visits, researchers will check the implant's survivorship using Kaplan Meier analysis and assess device stability through radiological exams. They will also evaluate clinical outcomes using the Harris Hip score and monitor safety by collecting any adverse events up to 10 years after surgery. This comprehensive follow-up helps ensure detailed understanding of the device's long-term effects and performance.

Researchers are collecting data to assess the safety and effectiveness of the Truliant® knee prosthesis used in total knee replacement surgeries. This observational study aims to gather clinical and patient outcomes, including survivorship data, from individuals who have received or will receive this knee device. The study focuses on patients with various knee conditions, such as osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis, who have undergone or will undergo surgery involving the Truliant® system. Participants include those enrolled before surgery, those enrolled after surgery who continue to participate prospectively, and those enrolled only retrospectively with no prospective follow-up. The study collects data from medical records and patient follow-ups over an extended period. The Truliant Total Knee System, compatible with Optetrak components, is the device being evaluated. Surgeries are performed by investigators or surgeon sub-investigators following approved device indications. During the study, participants will complete assessments using tools such as the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), Oxford Knee Score, and Visual Analog Scale (VAS) for pain at multiple time points from before surgery up to ten years post-surgery. Data collection includes demographic, operative, and postoperative information obtained from medical records and patient responses. This long-term follow-up helps researchers monitor outcomes and device performance over time, with the study expected to continue until 2035.

Researchers are evaluating the safety and performance of the ORIGIN4 CR (cruciate retaining) devices used in total knee replacement surgery. This observational study aims to measure the safety by tracking the proportion of patients needing revision surgery one year after the procedure and to assess performance using the Knee Society Score (KSS) both for the knee and function at one year. The hypothesis is that patients will notice a significant natural feel improvement in the prosthesis within the first year, with slight further gains at two years, along with better overall satisfaction. The study will include 199 patients who will receive treatment with the ORIGIN4 CR devices and associated instruments. Patients will be enrolled over an 18-month period and followed for 24 months. This single-arm study does not include a comparison group and will monitor patients up to two years after their surgery to assess outcomes. Participants will be asked to attend follow-up visits at one and two years after their surgery. During these visits, researchers will evaluate safety through revision rates and assess performance using the Knee Society Score and Function Score, patient satisfaction surveys, and the Forgotten Joint Score questionnaire. The study focuses on understanding quality of life and prosthesis function after total knee replacement with the ORIGIN4 CR device.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are evaluating the safety and performance of the Incompass™ Total Ankle System in people who have ankle replacement surgery. The study aims to measure improvements in quality of life and pain through patient-reported information and routine medical imaging such as X-rays and CT scans. This system has been approved by the Food and Drug Administration and is already used in ankle replacement surgeries, so no part of the study is experimental. The study plans to enroll about 200 participants over three years at up to ten locations. Participants will receive a total ankle replacement surgery using the Incompass™ Total Ankle System, following the surgeon's usual care practices. The study will include reviewing medical images taken as part of routine care and any additional X-rays during the study period to assess the device's performance. Participants will be followed for up to 10 years with scheduled assessments at baseline, 6 months, 1, 2, 5, 7, and 10 years after surgery. Assessments include the Ankle Osteoarthritis Scale, Foot and Ankle Ability Measure, PROMIS Global Health questionnaires, TAR Satisfaction surveys, and radiographic evaluations. Safety will be monitored by tracking adverse events, reoperations, and implant survivorship. Participants will attend all required study visits and complete questionnaires during these times.

Researchers are studying patients with knee osteoarthritis who are undergoing total knee arthroplasty (TKA) to compare three different steroid administration methods during surgery. This study aims to understand which method—intravenous steroid, intra-articular steroid, or no steroid supplementation—provides better outcomes in terms of pain relief and recovery. It is a randomized, double-blind trial designed to evaluate these approaches over a long period. The study involves three groups of patients receiving different treatments: one group will receive 9 mg of intravenous dexamethasone during surgery, another will receive 9 mg of intra-articular dexamethasone, and the control group will receive the standard anesthesia protocol without steroids. Each group will consist of 53 patients, totaling 159 participants. The interventions are perioperative and occur at the time of surgery. Participants will be followed for up to 10 years with assessments including pain levels at rest in the first 3 days after surgery, knee function, pain intensity, opioid consumption, time to first mobilization, and length of hospital stay. Researchers will also monitor safety by recording steroid-related complications such as infections and hyperglycemia. The study will collect data at multiple points, including up to 10 years post-surgery, with primary data analysis planned after one year of follow-up.