Zoetermeer

Researchers are studying the CapFlex PIP implant system for patients with osteoarthritis affecting the proximal interphalangeal (PIP) joint, a common site for joint replacement surgery. The study aims to understand how well the implant stays fixed and how it moves over time, using a specialized imaging method called model-based roentgen stereogrammetric analysis (mRSA). This information is important to improve implant durability and reduce failures over the long term. The study will follow patients for 10 years to monitor these patterns and also assess implant survival, clinical outcomes, and X-ray findings. Patients in the study will receive the CapFlex PIP implant as part of their regular surgical care. During the operation, small markers made of tantalum will be placed in the bone around the implant to enable detailed imaging analysis. The follow-up visits will occur at 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years after surgery to track the implant's position and condition using mRSA. Participants will be evaluated before surgery and at each follow-up visit using questionnaires and imaging tests. The main measurement is the change in implant movement in millimeters over time. Additional assessments include clinical scores and radiographs to evaluate implant survival and joint function. Patients will attend extra hospital visits beyond standard care to complete questionnaires and undergo mRSA imaging, which may help detect complications earlier. Overall, participation lasts 10 years with multiple evaluations to ensure thorough monitoring.

Researchers are evaluating follow-up care schedules after total hip or knee replacement surgery in adults aged 50 and older. The study aims to determine if reducing routine follow-up visits, specifically the 1-year appointment, is safe and effective compared to standard care. The goal is to potentially lower the number of unnecessary hospital visits and reduce the burden on patients, caregivers, and healthcare professionals, while revising current clinical guidelines accordingly. Participants receive one of two follow-up care plans: Routine Follow-Up (RFU), which includes scheduled X-rays and clinical visits at 3 months and 1 year after surgery; or Check-Up on Demand (COD), which involves a scheduled visit at 3 months and an additional 1-year visit only if requested by the patient or healthcare provider. This study is part of a larger trial consisting of three work packages, with this segment focusing on follow-up during the first year after surgery. During the study, participants' physical function is assessed using PROMIS Physical Function measures before surgery and at 3, 12, 15, 18, and 24 months post-surgery. Researchers also track the number of clinical visits and X-rays from surgery until 24 months later. Patients complete questionnaires and clinical evaluations, with ongoing monitoring to ensure safety and capture any additional follow-up visits as needed.

Researchers are investigating how four different suturing techniques affect the amount of abnormal wound healing within 14 days after total hip replacement surgery at RHOC in Zoetermeer, The Netherlands. The study compares Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip suturing methods, aiming to determine which method leads to the most wound healing issues. The hypothesis is that Monocryl sutures may cause the highest amount of abnormal wound recovery in this period. The study involves four suturing techniques: Monocryl Smooth Suture and Vicryl Rapide Braided Suture placed under the skin, with Indermil skin glue applied after Vicryl Rapide. Additionally, two newer skin closure systems, Dermabond Prineo and Stryker Zip, which use adhesive strips and skin glue or tightening strips to close the wound without invasive sutures, are also being evaluated. Some methods are part of standard care, while others are used elsewhere but not yet standard at RHOC. Participants will take photos of their wound dressings at home on days 3 and 11 after surgery. Photos of the actual surgical wound will be taken at outpatient visits on days 7 and 14 post-surgery by the research team and doctor's assistant. Researchers will assess these images using a special classification model to measure wound healing progress and identify any abnormal recovery. The main outcome is the number of participants with abnormal wound healing within 14 days after surgery.

Researchers are evaluating personalized blood thinner treatments after hip or knee replacement surgeries to reduce the risks of blood clots (venous thromboembolism or VTE) and bleeding. Currently, all patients receive the same standard blood thinner treatment, but some still develop blood clots while others experience bleeding. This study aims to see if adjusting the blood thinner dose and duration based on each patient's risk can lower these complications. Participants are divided into three groups based on their predicted risk of blood clots using a scoring system. Patients with low risk receive blood thinners only during their hospital stay. Those with intermediate risk are observed without changes to standard care. Patients with high risk get a higher dose and longer duration of blood thinners for six weeks. The blood thinners used include types such as LMWH or DOACs, given according to local guidelines and timing specified after surgery. Participants complete four questionnaires: one before surgery and three after surgery at 2 weeks, 6 weeks, and 3 months, to report any blood clots or bleeding events. If a participant experiences a clot, major bleed, or infection, an additional questionnaire about quality of life and joint function is sent one year later. No extra hospital visits are required. The main outcomes measured are blood clot and major bleeding events within 90 days after surgery.

Background: The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. The CS insert is anterior-lipped (AL) to prevent anterior translation of the femur on the tibia with flexion and compensate the function of the PCL. Currently both the CR and CS insert are made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear related osteolysis. However, this also might diminish the fracture toughness and crack propagation of the insert. The investigators expect that due to the high contact forces on the anterior lip of the CS insert during flexion, especially in younger and more active patients, and the lower fracture toughness of HXPLE, the CS insert insert might show more migration, wear or other damage compared to the CR insert in the long-term, which might lead to more revisions in the CS insert compared to the CR insert. To measure the migration and wear, during surgery tantalum markers will be inserted in the host bone using a marker inserter. The displacement of the prosthesis with reference to the host bone will be measured using model-based RSA. Both tantalum markers ande the inserter are already used for study purposes. However, the safety and usability are not registered before. Objective: The primary objective is to compare the migration of both the femoral and tibial component by the use of a CS insert or CR insert both made of HXPLE using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore, the safety and usability of the tantalum markers and the marker inserter will be determined. The secondary objective is to determine the influence of the type of insert on the wear, inducible displacement, survival and clinical outcomes. Study design: A randomized controlled trial Study population: Forty-four patients scheduled to undergo primary total knee replacement, aged below 70 years with an ASA-score of 1 or 2 will be needed in total, divided in two groups of 22 patients each. Intervention: One group receives an uncemented TKP with a CS insert, while the other group receives an uncemented TKP with a CR insert. Both will be placed using the MAKO-robotic arm using a kinematic balancing technique. Outcomes: Main study parameters are migration of the femoral and tibial components measured with model-based RSA software till 10 years postoperatively. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or the marker inserter will be registered. The secondary parameters are wear, inducible displacement, survival, clinical outcomes and complications up to 10 years postoperatively.

The trial investigates short-term recovery and patient experiences following surgery for trapeziometacarpal (TMC) joint osteoarthritis, a common hand and wrist condition. It compares two widely used surgical procedures: trapeziectomy and TMC-joint arthroplasty. The study aims to gather information on pain, the use of pain medication, function, and quality of life during the first eight weeks after surgery, as no previous studies have clearly shown the superiority of one procedure over the other or detailed early recovery data. Participants will undergo either trapeziectomy or TMC-joint arthroplasty, with 100 subjects in each group. The study is observational and prospective, using daily diaries and questionnaires to track recovery over eight weeks. There are no additional treatments or interventions beyond the planned surgeries. Subjects will be asked to record their experiences in a diary, which takes about five minutes daily during this eight-week post-surgery period. During the study, participants will complete daily diaries and questionnaires to assess pain, function, and quality of life. The main outcomes are measured at eight weeks post-surgery. Researchers expect no risks from participation, and no direct benefits for subjects are anticipated. The study focuses on understanding patient recovery experiences and monitoring postoperative progress with minimal burden on participants.

Many individuals in long-term disability care, including those with conditions such as autism spectrum disorder, mild to moderate intellectual disability, acquired brain injury, and Down syndrome, face challenges with daily structure and planning. This study evaluates the (cost)effectiveness of a social robot designed to reduce the frequency of professional caregiver support and promote independence for these individuals. The research aims to understand the robot's impact on caregiver support frequency after 6 weeks, its lasting effects after 6 months, and its cost-effectiveness. Participants will use a small flowerpot-shaped social robot called Tessa, which provides spoken reminders at preset times. The robot is programmed through a web app by either the participant or their professional caregiver. Together, they set 3 to 5 personalized goals to improve daily activities, which are monitored weekly using an individualized evaluation scale. The study follows a multiple baseline design where participants first receive care as usual, then use the robot while progress is tracked. During the 13-week study period and a 2-week follow-up, participants will complete surveys about their quality of life and well-being, and share their experiences in interviews. Professional caregivers will record the frequency and duration of support they provide daily, update goal progress weekly, complete questionnaires on participant productivity and healthcare use, and also participate in interviews. The main outcome measured is the weekly frequency of professional caregiver support throughout the study and follow-up periods.