Clinical Research Directory

Development of an Outcome Score for Patients With Knee Osteoarthritis and Knee Joint Endoprosthesis Using an App

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) is one of the most frequent orthopedic procedures. Over 50% of patients report higher expectations than their surgeons, and 10-50% remain dissatisfied postoperatively. Persistent pain, functional limitations, and unmet expectations are key drivers. Identifying risks pre- and early postoperatively is essential, alongside empowering patients through self-management. Existing scoring systems integrate PROMs, demographics, and sometimes imaging but within limited timeframes. They rarely capture functional deficits or long-term trajectories. Digital health solutions for TKA (pre-)rehabilitation exist, yet most focus on physiotherapy and education rather than predictive outcome modeling. To address this gap, the study team has developed a novel mobile application that enables the documentation and analysis of movement data up to 10 years before surgery and throughout long-term follow-up. These data are combined with PROMs and functional test results, providing a unique basis for outcome prediction and risk stratification in TKA/THA. Primary Objective The aim of this pilot study is to develop a composite outcome score for TKA/THA patients. This score will integrate demographic variables, PROMs, and objective functional measures (knee joint angles, gait parameters, walk tests) to identify risk factors for dissatisfaction and support predictive modeling. A machine learning algorithm will be trained using the collected dataset to predict patient satisfaction after TKA/THA. Endpoints Primary endpoint: Overall patient satisfaction Secondary endpoints: Age, height, weight, step count, step length, gait asymmetry, gait speed, double support phase, knee joint ROM, walk test, KOOS, SF-36, EQ5d, satisfaction with the app, and satisfaction with app use. Study Population App-Group: Inclusion criteria are patients ≥18 years before or after TKA/THA. Exclusion criteria include missing consent, ineligible diagnosis, lack of smartphone, age \<18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients. Non-App-Group: Inclusion criteria are patients ≥18 years before or after TKA/THA. Exclusion criteria include missing consent, ineligible diagnosis, age \<18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients. Healthy-group: Inclusion criteria are healthy proband ≥18 years with no lower limb conditions. The overall procedure is identical to that of the AppGroup. Exclusion criteria include missing consent, ineligible diagnosis, no smartphone, age \<18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients. Methods Design: Single-center, prospective pilot study. The app collects patient-authorized movement data already stored on smartphones as well as future data. Participants choose which data to share. In addition, they are prompted to complete gait tests and knee function tests. PROMs (KOOS, SF-36, satisfaction) are administered at regular intervals.

DIPB vs. SIFIB for Postoperative Analgesia After Hip Surgery

This randomized, double-blind clinical trial aims to compare the effectiveness of the Deep Iliacus Plane Block (DIPB) and the Suprainguinal Fascia Iliaca Block (SIFIB) for postoperative pain control in patients undergoing primary total hip arthroplasty. Effective analgesia after hip surgery is essential for early mobilization, reduction of complications, and improved recovery outcomes. Seventy patients scheduled for elective hip arthroplasty under spinal anesthesia will be randomly assigned to receive either DIPB or SIFIB at the end of surgery. Postoperative pain scores, opioid consumption, motor block, and block-related complications will be evaluated over a 48-hour period. The study aims to determine whether DIPB provides superior or comparable analgesia with reduced motor blockade compared to SIFIB, thereby contributing to safer and more comprehensive postoperative pain management in hip surgery patients.

Sacral ESPB vs. PENG Block for Hip Hemiarthroplasty Analgesia

Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation and hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery . Described in 2018, pericapsular nerve group (PENG) block selectively targets the articular branches of the femoral and accessory obturator nerves thereby providing potential motorsparing analgesia for hip surgery . Recent studies found that PENG block targets the articular branches of the femoral and accessory obturator nerves, only anesthetizes the anterior hip joint sparing posterior part , as well as there was a motor impairment after block which is from local anesthetic (LA) diffusion to the femoral nerve . Motor-sparing regional anesthesia techniques have emerged as a safer alternative, balancing effective pain relief with the preservation of quadriceps function . These techniques align with Enhanced Recovery After Surgery (ERAS) protocols, which emphasize multimodal pain control, opioid minimization, and early mobility to reduce complications such as venous thromboembolism (VTE) and postoperative pneumonia .

Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic

This multicenter, prospective, non-interventional observational study (ORTOPODCZ) investigates the association between preoperative cognitive impairment and postoperative delirium (POD) in older adults undergoing elective total hip arthroplasty in the Czech Republic. Postoperative delirium is a frequent and serious neurocognitive complication in senior surgical patients and is associated with increased morbidity, mortality, prolonged hospitalization, and impaired functional and cognitive outcomes. Despite international recommendations, routine preoperative cognitive screening remains insufficiently implemented. The study evaluates the predictive value of the ALBA test, a brief cognitive screening tool, performed during the pre-anesthetic assessment. Postoperative delirium will be assessed using the validated CAM-ICU instrument for up to 72 hours after surgery. Secondary objectives include assessing the relationship between POD and frailty, polypharmacy, comorbidities, type of anesthesia, intraoperative hemodynamics, blood loss, vasoactive support, and postoperative complications. Approximately 300-400 participants aged ≥65 years will be enrolled across seven centers. No additional procedures, biological sampling, or deviations from standard clinical care are required. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study aims to provide robust evidence supporting the integration of cognitive screening into routine preoperative evaluation and to describe feasibility and implementation requirements for the ALBA test in clinical practice.

Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment. The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis. Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis. A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting. No previous clinical trial

SFIB vs PENG Block in the Anesthesia for Total Hip Replacement

Total hip replacement is one of the most common orthopedic operations. According to statistical studies, more than 1 million of such surgical interventions are performed annually in the world. The average age of primary hip replacement surgery is 69 y.o. Modern approaches of control of general anesthesia allow safe performance of different surgical interventions under general anesthesia. However, general anesthesia does not have an effective and long-lasting effect on relieving operational stress compared to neuraxial anesthesia. To achieve a similar effect, it is necessary to adhere to the principle of multimodality of anesthesia, and the most promising method is a combination of general and regional anesthesia. peripheral blocks are described in the literature, aimed at analgesia directly in the hip joint area, and effectively used in orthopedics. Most blocks are currently performed under ultrasound control, the risk of nerve damage and accidental intravascular administration of local anesthetics is potentially reduced. It was established that the use of ultrasound guidance reduces the number of attempts and the amount of anesthetic administered, as well as reduces the time required to perform a block. Another predicted effect is a reduction in the doses of opioids and non-steroidal anti-inflammatory drugs (NSAIDs), which can cause gastrointestinal bleeding and have a nephrotoxic effect, and can also depress breathing. It should be noted that patients over 65 y.o., have the highest risks of these side effects. This study aims to compare the effectiveness and safety of SFIB and PENG block in hip replacement, as well as evaluation of the effectiveness of combined anesthesia in comparison with general anesthesia without the use of peripheral blocks.

OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study

Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. More recently, surgery using the direct anterior approach is getting popularity: this method, in fact, granting a significant sparing of the hip muscles, is associated with favorable results compared to other techniques, such as a lower risk of dislocation, limitated damage to soft tissues with better recovery and early discharge. Patients undergoing this procedure may although experience moderate to severe postoperative pain in the first few hours (with peaks observed in the first 12 hours), as well as potential complications such as nausea and vomiting related to opioids use. It has been shown that adequate pain control influences early mobilization and rehabilitation, ensuring a quicker recovery. The role of regional anesthesia techniques has been established in almost all areas of orthopedic surgery, and in particularly in the management of postoperative pain following hip replacement surgery, but definitive data are missing with regard to direct anterior approach. Regional anesthesia consists of infiltrating local anesthetics in sites (fascial planes or nerves), in order to limit or even eliminate the use of traditional painkillers, with a significant reduction in the side effects. The aim of this study is to compare the impact of two techniques, the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, in managing postoperative pain in subjects undergoing total hip replacement surgery performed by direct anterior approach. The primary objective of the study is the incidence of residual femoral and obturator nerves block (knee extension and hip adduction according to ASIA score) 8 hours after surgery in the two treatment groups. Secondary objectives include: • Time elapsed between the end of surgery and the recovery of lower limb motility enough to allow the patient to mobilize independently; • Total opioid consumption (calculated as morphine equivalents) at 8, 24 and 48 hours after surgery; • Pain according to NRS (numerica rating scale) at 8, 24 and 48 hours after surgery; • Extent of sensory block of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) at 8, 24 and 48 hours after surgery; • Timing of hospital discharge; • Incidence of chronic or persistent postoperative pain (at 30 and 90 days after surgery); • Any postoperative complication

Hospital for Special Surgery Hip Arthroplasty Cohort

Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes. Most health related quality of life studies in THA and TKA only report data up to twelve months post-operatively. In addition, most large studies of TKA and THA have been performed in Medicare patients. While these databases are important in providing population based data, Medicare studies do not permit any direct patient contact, and provide no information on patients under 65. Existing studies have also investigated predictors of patient outcome at one and two years after joint arthroplasty. However, very little is known about predictors of prosthesis failure, and there are no validated clinical indicators for choosing one prosthesis model over another. Once a device is FDA approved, there is very little motivation on the part of the developer to perform complete post-marketing research, despite the importance of these data to the public health. Most existent studies are not powered to compare differences between models. The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.

FAB Block vs. Placebo for Hip Arthroplasty Patients

Hip arthroplasty surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize that FAB will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroplasty. This is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. A comparison of pain will be made between both groups.