Zoetermeer

Researchers are studying patients with osteoarthritis affecting the proximal interphalangeal PIP joint to understand the long-term behavior of the CapFlex PIP implant system. This implant is a modular surface replacement used in joint arthroplasty, which has shown good short-term results with few complications. The study aims to assess how well the implant attaches and whether it moves over time by using a special imaging technique called model-based roentgen stereogrammetric analysis mRSA across 10 years. Patients receive the CapFlex PIP implant as part of their regular treatment, during which small markers are placed in the bone around the implant. The study follows 36 patients, checking them before surgery and then at 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years after surgery. This allows researchers to track the implants movement in three directions, its survival, clinical function, and X-ray features over time. Participants will attend multiple visits for evaluations including imaging with RSA, clinical questionnaires about hand function and quality of life, and pain assessments. These extra visits occur alongside their usual care to help detect any problems with the implant early. The study measures changes in implant position, rotation, survival, and patient-reported outcomes, with follow-up lasting 10 years to provide detailed long-term information.

Researchers are evaluating the benefits and costs of routine follow-up appointments after total hip or knee replacement surgery, particularly focusing on the 1-year follow-up visit. Current guidelines recommend follow-ups with X-rays at 3 months, 1 year, and then every 5 years for knee or hip replacements. However, these frequent visits may require significant time and resources from patients, caregivers, and healthcare providers, and it is unclear if all scheduled visits are necessary. The HAKA trial aims to safely reduce these routine follow-ups and update clinical guidelines accordingly. The trial compares two approaches one group receives standard care with X-rays and clinical visits at 3 months and 1 year after surgery, while the other group has the same 3-month visit but only a 1-year visit if requested by the patient or healthcare provider. This randomized study is part of a larger research program including long-term follow-up and qualitative studies about patient and provider experiences. Participants receive care following these schedules and are monitored over time. Participants will complete questionnaires assessing physical function, pain, and quality of life before surgery and at several intervals up to 24 months after surgery. Researchers will track the number of clinical visits, X-rays, complications, additional surgeries, and related costs during this period. The study monitors outcomes to evaluate whether reducing routine follow-ups is safe and cost-effective. Overall participation lasts about two years, with regular assessments to guide care decisions.

Researchers are evaluating how four different suturing techniques affect wound recovery after total hip replacement surgery. The study focuses on comparing Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip to see which technique leads to the least abnormal wound healing within 14 days after surgery. The trial is randomized and conducted at the Reinier Haga Orthopedisch Centrum in the Netherlands, aiming to assess wound recovery through photographs and a classification model. Participants receive one of four skin closure methods Monocryl Smooth Suture placed under the skin, Vicryl Rapide Braided Suture combined with Indermil skin glue, Dermabond Prineo Skin Closure System which uses a transparent mesh with glue, or Stryker Zip Skin Closure System consisting of adhesive strips tightened to close the wound. Some of these methods are standard care at the study site, while others are newer and used elsewhere. Photographs of the plaster and wound will be taken at specific times post-surgery by participants and healthcare staff. During the study, participants take photos of their wound dressings at home on days 3 and 11 after surgery. Healthcare professionals will photograph the wound itself during clinic visits on days 7 and 14. Researchers will measure the number of participants with abnormal wound recovery up to 14 days after surgery. Additional outcomes include wound infections, patient satisfaction, complications, and healthcare visits monitored up to 90 days. The total participation duration covers these assessments and follow-up periods.

Researchers are evaluating whether customizing blood thinner treatment after hip or knee replacement surgery can reduce both blood clots and bleeding compared to the standard approach used for all patients. This study focuses on patients undergoing elective total hip or knee arthroplasty and aims to determine if shorter treatment is safe for low-risk patients and if higher doses for high-risk patients lower clot risks without causing too much bleeding. Participants are grouped based on their predicted risk of venous thromboembolism VTE using a risk score called TRiPplasty. Low-risk patients are randomly assigned to either a shortened prophylaxis during hospital stay only or standard treatment for about 4 weeks. High-risk patients are randomly assigned to receive intensified and extended prophylaxis for 6 weeks or standard treatment. Intermediate-risk patients participate in an observational arm without treatment changes. Treatments include types of blood thinners such as low molecular weight heparin or direct oral anticoagulants given according to Dutch guidelines. During the study, participants complete four questionnaires one before surgery, and at 2 weeks, 6 weeks, and 3 months after surgery to assess blood clots and bleeding events. An additional questionnaire at 1 year evaluates quality of life and joint function for those who experienced complications or a matched group. No extra hospital visits are required. Researchers will measure rates of venous thromboembolic events and major bleeding within 90 days, along with other health outcomes and patient-reported quality of life.

Researchers are comparing two types of inserts used in total knee replacement surgery the Condylar Stabilizing CS insert and the Cruciate Retaining CR insert, both made from highly cross-linked polyethylene HXPLE. This study focuses on patients under 70 years old undergoing primary total knee arthroplasty TKA with an intact posterior cruciate ligament PCL. The goal is to evaluate differences in implant migration, wear, and clinical outcomes over a long-term period of up to 10 years. During surgery, patients receive either an uncemented TKA with the CS insert or the CR insert, both implanted using a MAKO robotic arm and a kinematic balancing technique. Tantalum markers are also placed in the bone to measure implant movement using model-based roentgen stereophotogrammetric analysis mRSA. These markers and the marker inserters safety and usability will be assessed as part of the study. Participants will be followed for 10 years with regular evaluations of implant migration, wear, inducible displacement, and survival. Clinical outcomes will be measured using various scores including the Knee Society Score, pain rating scales, and quality of life assessments. Safety monitoring includes tracking complications related to the tantalum markers and the surgical procedure. This long-term follow-up aims to provide detailed information on the performance and safety of these knee replacement inserts.

Researchers are studying short-term recovery and patient experience after two common surgeries for trapeziometacarpal TMC joint osteoarthritis trapeziectomy and TMC-joint arthroplasty. This observational cohort diary study involves 200 adults with TMC joint osteoarthritis, with 100 patients undergoing trapeziectomy and 100 undergoing TMC-arthroplasty. The study aims to gather detailed information on pain, function, quality of life, and use of pain medication during the first 8 weeks after surgery. Participants receive either trapeziectomy or TMC-joint arthroplasty as treatment for arthrosis of the first carpometacarpal joint. The study follows these two groups separately, tracking their recovery experience without assigning treatments since it is observational. There is no experimental intervention beyond monitoring usual care and collecting patient-reported outcomes. The study includes a rehabilitation schedule and postoperative functional assessments. Participants will complete daily diaries for about five minutes each day over the initial 8 weeks after surgery to report on pain, medication use, function, and quality of life. Researchers will also collect long-term data on complications and standardized questionnaires up to one year after surgery. The main outcomes focus on pain, function, and quality of life during the early recovery period. There is no direct benefit expected from participation, and risks are minimal since only diaries and questionnaires are involved.