Clinical Research Directory

Trident II Tritanium Acetabular Shell Outcomes Study

The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.

Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty

The goal of this clinical trial is to compare two regimens of the pericapsular nerve group (PENG) block, an ultrasound-guided injection of local anaesthetic targeting the nerves supplying the front of the hip joint, for postoperative pain relief and quadriceps muscle function in patients undergoing primary unilateral total hip arthroplasty under spinal anaesthesia. The PENG block was originally proposed as a motor-sparing technique. However, the standard 20 mL volume can spread to the femoral nerve and cause quadriceps weakness. Reducing the injected volume may limit this spread and better preserve quadriceps strength, but smaller volumes risk shorter analgesic duration. Adding dexamethasone to a low-volume injection may compensate for the reduced volume. The main questions this trial aims to answer are: * Does a low-volume PENG block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone differ from a standard-volume PENG block (20 mL bupivacaine 0.25%) in the time to first rescue analgesia? * Does it differ in the incidence and severity of quadriceps weakness on the operated side? Researchers will compare: * Group A (standard-volume PENG block): 20 mL bupivacaine 0.25%. * Group B (low-volume PENG block with dexamethasone): 5 mL bupivacaine 0.5% plus 4 mL normal saline plus 4 mg dexamethasone in 1 mL, giving 10 mL of bupivacaine 0.25%. Participants will: * Receive spinal anaesthesia with heavy bupivacaine 0.5% and fentanyl. * Be randomly allocated to Group A or Group B using computer-generated random numbers. * Receive the PENG block under ultrasound guidance, performed by an anaesthesiologist expert in regional anaesthesia. * Receive intravenous paracetamol 1 g every 8 hours, with intravenous nalbuphine 5 mg as rescue analgesia when the pain score (NRS) is 4 or more. * Be assessed by an anaesthesiologist blinded to group allocation for pain scores at rest and on movement at 2, 6, 12 and 24 hours; quadriceps strength (MRC scale and straight leg raise) at 6, 12 and 24 hours compared with the preoperative baseline; total opioid consumption over the first 24 hours; and time to first ambulation within the first 24 hours. The primary outcome is the time from completion of the PENG block to the first administration of rescue analgesia, recorded over the first 24 hours postoperatively. The study will be conducted at Ain Shams University Hospitals (El Demerdash Hospital) and will include 60 patients (30 per group), aged 50 to 70 years, ASA physical status I or II.

Tau Pathology in the Brain After Hip or Knee Replacement Surgery

The goal of this observational study is to study whether major surgery is linked to changes in the brain that are typical of Alzheimer's disease. The study is a prospective observational study that will be carried out in Uppsala University Hospital. Adults aged 55-75 years who are healthy otherwise American Society of Anesthesiologists (ASA) 1-2 having a hip or knee replacement under spinal anesthesia, and a comparison group of people of the same age and sex with hip or knee arthrosis who are not having surgery will be included. The main questions it aims to answer are: * Does the amount of the protein tau in the brain increase in the two years after surgery? * Are changes in tau linked to inflammation in the blood and spinal fluid, and to changes in memory and thinking? Participants will: * Have brain scans with positron emission tomography (PET) and magnetic resonance imaging (MRI) scans before surgery and 12 and 24 months later * Give small samples of spinal fluid and blood * Complete memory and thinking tests at the same time points Researchers will compare the surgery group with the non-surgery group to see whether surgery is associated with more tau in the brain and with changes in memory and thinking.

Early Mobilization and Postoperative Complications in Hip Arthroplast

Orthopedic surgical procedures, particularly total hip replacement, are of great importance in the older population in terms of regaining functional independence, reducing pain, and improving quality of life. In addition to surgical success, the postoperative recovery process, rehabilitation programs, patient education, and nursing care directly affect patients' clinical and functional outcomes. Failure to implement early mobilization may negatively affect patients' recovery and increase the risk of complications. Delayed mobilization may prolong hospital stays and increase healthcare costs. The most common complications include deep vein thrombosis, pulmonary embolism, respiratory complications, muscle weakness, and joint stiffness. Delayed mobilization may also increase postoperative pain and functional limitations, thereby restricting patients' ability to perform independent activities of daily living. Patient education during the postoperative period is one of the key factors supporting the success of early mobilization. Education provided to patients regarding postoperative positioning, breathing exercises, pain management, protection of the prosthetic area, and the importance of mobilization can help reduce complications and improve patient adherence. When education is planned individually under the guidance of nurses, it supports functional independence and facilitates the rehabilitation process.

Does Rehabilitation After Total Hip Or Knee Arthroplasty Work (DRAW2)

Overall frame: The overall or "parent" DRAW-project is a large-scale project run in Denmark that aims to provide substantial level 1A evidence-data related to the question: Does rehabilitation after total hip and knee replacements work? In the DRAW project, the authors challenge the belief that physical rehabilitation is clinically important - and surely better than "no physical rehabilitation". To challenge this belief thoroughly, the DRAW project holds many individual work packages centered around the same question. These work packages will be conducted in collaboration with municipality rehabilitation centers in Denmark so that specific usual care strategies are reflected in the different trials and local clinical relevance is as well as implementation potential are increased. Explanatory statement: Because the DRAW2 trial was conceived as a direct methodological replication of DRAW1, early administrative procedures mistakenly linked the new cohort to the existing DRAW1 registration (NCT03750448). This was an internal administrative misunderstanding rather than an attempt to obscure trial conduct or outcomes. Following guidance from the Regional Ethics Committee, it became clear that DRAW2 should be registered as an independent study to ensure transparent reporting of its distinct protocol, sample, and analyses. Consequently, a separate ClinicalTrials.gov entry was created once this requirement was identified. We like to document the administrative origin of the discrepancy while confirming that it had no impact on blinding, allocation concealment, or the scientific integrity of the trial.

Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use

This study examines whether patients undergoing total hip replacement surgery can manage their pain effectively while using fewer opioid pain medications. Participants will be randomly assigned to one of two groups. The first group will receive the standard postoperative pain medication regimen, with all prescriptions sent directly to their pharmacy as usual. The second group will receive the same medications, but their opioid prescription will only be provided as a printed copy rather than being sent directly to the pharmacy, requiring them to choose whether to fill it. All participants will keep a pain journal and complete questionnaires about their medication intake over the first 21 days post-op as well as there function and wellbeing at follow up visits over 3 months. The goal is to determine whether this approach reduces opioid use while still adequately controlling pain after hip replacement surgery.

PENG Block + LIA For Endoprosthesis Surgery

The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are: * Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery? * Does the new technique allow participants to move their leg sooner after the operation? Researchers will compare the new local anesthesia technique (numbing medicine injected directly around the hip joint) to standard spinal anesthesia (a numbing injection in the back) to see if the new technique works just as well for pain control while possibly causing fewer side effects like nausea. Participants who join this study will be randomly placed into one of two groups. One group will receive the standard spinal anesthesia before their surgery. The other group will receive the new local anesthesia technique before their surgery. After the operation, researchers will track the amount of extra pain medicine each participant uses and will check their ability to move their hip, knee, and foot.

Analgesic Efficacy of Continuous SESP vs Continuous FICB After Hip Arthroplasty

The primary objective of this prospective, randomized, observer-blinded controlled trial is to compare the postoperative analgesic efficacy of continuous intermediate-approach sacral erector spinae plane (SESP) block versus continuous supra-inguinal fascia iliaca compartment block (FICB) in adult patients undergoing elective posterior-approach total hip arthroplasty under spinal anesthesia. Sixty patients will be randomly allocated to receive either a continuous SESP block or a continuous supra-inguinal FICB. Both techniques involve an initial bolus of 30 mL 0.1% ropivacaine followed by intermittent boluses of 20 mL 0.1% ropivacaine every 6 hours for 72 hours via an indwelling catheter, in addition to standardized multimodal analgesia. The primary outcome is cumulative morphine milligram equivalents (MME) consumption over the first 72 postoperative hours. Secondary outcomes include pain scores at rest and during movement (NRS), quality of recovery (QoR-15) at 72 hours, motor function (modified Bromage scale), and adverse events. We hypothesize that continuous SESP block will provide superior opioid-sparing analgesia compared with continuous supra-inguinal FICB while maintaining comparable pain control, quality of recovery, and motor function preservation.

Sleep Patterns After Total Joint Replacement Surgery

The purpose of this study is to determine sleep patterns and sleep quality following total joint arthroplasty, in order to understand when patients should expect to return to baseline or improved sleep following total joint arthroplasty. Patients prospectively enrolled in this study are to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA). Patients will receive the SleepScore Max device and smart device app to track their sleep patterns starting one week prior to surgery and until six months after surgery. The SleepScore Max device tracks duration of sleep, time to fall asleep, number of nightly awakenings, rapid eye movement sleep, light sleep, deep sleep, and room temperature and light levels. Through the associated application, patients will also record caffeine and alcohol consumption and exercise. In addition to sleep tracking, patients will fill out Pittsburgh Sleep Quality Index (PSQI), PROMIS, Hip Disability and Osteoarthritis Outcome Score (HOOS), and Knee Injury and Osteoarthritis Outcome Score (KOOS) surveys at specified visits. Secondarily, Visual Analog Pain (VAP) scores and opioid consumption measure in milligram morphine equivalents (MME) will be measured during hospital stay and at subsequent post-operative clinic visits. The clinical goal of this study is to better under sleep patterns in patients undergoing TKA and THA and hopefully provide this patient population improved sleep recommendations and interventions.

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.

Preoperative Fasting and the Gut Microbiome Before Hip Replacement

Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters. This single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-/B-/NK-cell subsets, activation/exhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay). Adults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h / 24 h / 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.

Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty

Fascia iliaca compartment block (FICB) is a documented option for postoperative analgesia for total hip arthroplasty (THA) surgery. FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available motor sparing techniques are not as effective as FICB for analgesia. Low concentration local anesthetics (LCLA) are used with excellent results for pain control with no or minimum motor block effect, in other scenarios (highlighted in obstetric anesthesia) and techniques (epidural anesthesia, for instance). This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia, while at the same time avoiding motor blockade and muscle weakness. The investigators hypothesize that LCLA-FICB, when compared to conventional high concentration local anesthetics (HCLA) FICB, provides similar postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.

A Study of the Effect of a Nurse Navigator Program on High Risk Patients

The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.

A Post Market Clinical Follow-up Study With the aneXys Cup

The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Development and Measurement of the Effects of a Digital Education Solution for Patients Undergoing Total Hip or Knee Arthroplasty

This study aims to evaluate the effectiveness of a digital patient education solution, CHUVeduc@home, in improving preoperative preparation for patients undergoing total hip or knee arthroplasty. In Switzerland, many patients receive joint replacements each year to relieve osteoarthritis-related pain. With shorter hospital stays, adequate preparation before surgery has become increasingly important. A total of 160 patients will be randomized into two groups: Intervention group: access to CHUVeduc@home before surgery. Control group: standard preoperative preparation (group information session and consultation). All participants will complete questionnaires through the application. No additional visits are required. The intervention lasts approximately 12 weeks. The primary goal is to determine whether digital education increases patient knowledge, confidence, and satisfaction, and facilitates recovery and return home after surgery. Participation is voluntary and can be withdrawn at any time.

Associations Between Time to Reduction and Complications in Patients With Dislocated Total Hip Arthroplasty

The aim of the study is to investigate the impact of time to closed reduction on both patient related and organizational factors. These include, length of stay, hospitalization, admission to intensive care unit, rehospitalizations, delirium, all-cause mortality, infection requiring hospital contact, and cardiovascular complications. It is also intended to investigate whether different anaesthetic strategies and airway management are associated with different complication rates. It is hypothesized that longer waiting time until reduction increase the postoperative length of stay, readmissions, and risk of complications.

Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

To assess the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of orally administered SSS17 capsules in patients with postoperative anemia following elective total hip or knee arthroplasty.

TENS for Relief of Postoperative Pain in Orthopedic Patients

To ensure early mobilization, minimize suffering, and to prevent postoperative complications postoperative pain should be reduced as soon and as effectively as possible. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids. The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest as well as reduce opioid consumption.

Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

The purpose of this multicentre, prospective study is: * Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years. * Report Safety and Survivorship up to 10 years F/up.

CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

The purpose of this study is to analyze the efficacy and accuracy of real-time continuous glucose monitoring devices (rtCGM) in patients with Type 2 diabetes undergoing inpatient elective hip or knee surgery in the pre-, peri-, and post-operative setting at Stony Brook University Hospital (SBUH).