Clinical Research Directory

Analgesic Efficacy of Continuous S-ESP vs Continuous FICB After Hip Arthroplasty

The primary objective of this prospective, randomized, double-blind controlled trial is to compare the postoperative analgesic efficacy of continuous Sacral Erector Spinae Plane (S-ESP) block versus continuous Fascia Iliaca Compartment Block (FICB) in adult patients undergoing elective hip replacement surgery. The investigators hypothesize that the continuous S-ESP block will provide non-inferior or superior pain relief compared to continuous FICB, while potentially reducing the incidence of motor block and facilitating earlier postoperative mobilization. Participants will be randomly assigned to receive either an S-ESP or FICB catheter for continuous local anesthetic infusion over 48 hours postoperatively. Postoperative pain scores, opioid consumption, and functional recovery will be systematically evaluated.

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.

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.

PENG Block + LIA For Endoprosthesis Surgery With Anterior Approach

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.

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.

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.

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.

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.

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.

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).