350 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are: Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine. Participants will: Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls
Orthopedic Trauma Surgery Patients, Postoperative Pain, Opioid Use, Depression, Post-traumatic Stress Disorder (PTSD)
This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.
Dysbiosis, Gut -microbiota, Microbiome Analysis, Probiotic, Antibiotic Prophylaxis
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.
Lower Extremity Fracture
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.
Pediatric, Fracture, Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures), Patient Satisfaction
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. Participants will: * track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery
Shoulder Osteoarthritis, Rotator Cuff Injuries
The purpose of this study is to investigate orthopedic patients undergoing either a total hip replacement (THR) or total knee arthroplasty (TKR) using two dietary supplements, PREPARE and RECOVER, and their recovery times post-surgery.
Arthropathy of Knee, Arthropathy of Hip
The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.
Physiological Stress
Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of upper extremity surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators' goal is to evaluate the effectiveness of Exparel as compared to plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.
Distal Radius Fractures, Wrist Fractures
This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.
Metabolism; Disorder, Postprocedural, Resting Metabolic Rate, Post Operative Nutrition
This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds. Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.
Surgical Wound, Post Operative Wound Infection
Patients experiencing sports medicine-related injuries are particularly vulnerable to developing both chronic pain and experiencing prolonged opioid use. This multiarmed randomized controlled trial will quantify the impact of integrating Life Care Specialists, and pain management-focused paraprofessionals, have on increasing access to multimodal pain management approaches and subsequently optimizing both patient-reported pain-related outcomes and objective measures of activity. Life Care Specialists work with patients and clinicians on implementing non-pharmacological pain management approaches, specifically teaching participants how to implement mindfulness-based skills into their recovery, systematically conducting standardized biopsychosocial pain assessments, and coordinating care. By developing a toolbox of pain management approaches with the support of the Life Care Specialist, patients are well positioned to incorporate evidence-based pain management approaches into their recovery that result in improved psychosocial functioning and reduced opioid medication utilization. In total, 150 individuals with sports medicine injuries will be randomized to one of two intervention arms where they will work with a Life Care Specialist in person or over telehealth or receive standard-of-care written postoperative instructions for pain management. Patient-reported outcomes, objective actigraphy movement outcomes captured using wrist-based watches, and opioid utilization captured using medication event monitoring system (MEMS) caps will be evaluated over 3-months postoperatively for a total of 4 study visits.
Sports Medicine Injuries
This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing Orthopedic surgery (compared with usual care), while examining implementation outcomes.
Orthopedic Surgery, Older Adults, Depression, Anxiety
The GOLF study is a multicenter, prospective study with the goal to investigate golfers' return to the sport following hip, knee or shoulder arthroplasty. The prevalence of return to golf, by level of returning to golf will be assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Patients who are active golfers undergoing joint replacement will be identified from outpatient clinics and pre-assessment clinics and given information about the study at least two weeks prior to surgery. Participants in this study must have a desire to return to golf after surgery. Previous studies have only been able to report the return to golf after arthroplasty retrospectively; the prospective nature of this study will allow for a greater understanding of this process.
Hip Osteoarthritis, Knee Osteoarthritis, Shoulder Osteoarthritis
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).
Diabetes Mellitus, Type 2, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
Incision, Surgical
The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.
Knee Arthropathy, Hip Injuries
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.
Venous Thrombosis Deep (Limbs), Surgical Blood Loss
Cryotherapy has been used to enhance recovery after orthopaedic surgery. Many devices are available but few can guarantee a temperature regulation during a prolonged time and therefore have been criticized. The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after arthroscopic orthopaedic procedures.
Cryotherapy Effect, Compression, Postoperative Pain Management
The goal of this study is to test a new way to diagnose and track treatment of spine infections caused by the bacteria Staphylococcus aureus.
Staphylococcus Aureus Infection, Surgical Site Infection, Orthopedic Procedures, Spine
This study aims to determine the impact and effect of enhanced recovery after surgery (ERAS) principles in the recovery and rehabilitation of patients following elective orthopaedic spine surgery with a specific emphasis on oral versus intravenous preoperative medication administration and the resultant cost differences.
Lumbar Surgery
This is a randomized controlled trial. Patients will be randomly assigned to either the control or treatment group, with equal allocation using block randomization. The primary null hypothesis is that a combination sufentanil and buprenorphine based pain control regimen will not result in lower morphine equivalent requirements for pain control when compared to a classic fentanyl and hydromorphone based regimen. The secondary working hypothesis is that the patient satisfaction survey mean satisfaction scores will be higher in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The secondary null hypothesis is that the patient satisfaction surveys mean scores will not be significantly different in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The tertiary working hypothesis is that the patients will have significantly lower rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks. The tertiary null hypothesis is that patients have equivalent rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks.
Addiction Opiate, Chronic Pain, Fractures, Bone, Buprenorphine Dependence
This is a retrospective chart review to determine the etiologies contributing to prolonged PACU discharge at a major Orthopedic Ambulatory Center
Achilles Tendon Rupture, Database
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.
Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement
Virtual reality (VR) and augmented reality are becoming prominent in the medical sciences due to the increasing sophistication of VR technology and its improving haptics to simulate real-life situations. Previous medical VR studies focused on arthroscopic minimally-invasive procedures which often do not carry the risk of invasive procedures. OssoVR, an orthopedic surgery virtual reality company, has created a platform to run through different invasive orthopedic procedures prior to operating on a patient. Given that invasive procedures inherently carry more risk and variability than minimally invasive procedures, training tools to help with these operations are vital prior to performing on a patient. The research team will evaluate the face validity, transfer validity, and surgical recall of the orthopedic virtual reality software in an intramedullary (IM) tibial nail procedure. The research team will evaluate the simulation with medical students who have not had prior exposure to the procedure. Including medical students will allow for a larger sample size for more analysis. An IM tibial nail procedure is used in tibial fractures to help stabilize the fractured long bone via placement of a nail within the bone.
Virtual Reality, Surgical Training
Post-operative cognitive dysfunction (POCD) is a common concern for aging patients undergoing elective orthopedic surgery and significantly effects health outcomes. This study aims to evaluate the incidence of and risk factors associated with post-operative cognitive dysfunction in aging patients without prior history for mild cognitive impairment or dementia.
Post Operative Cognitive Dysfunction
To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol. Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.
Pain Management
Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.
Surgical Site Infection
Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.
Orthopedic Disorder
The primary objective of this study is to prospectively determine, at 10 days after orthopedic shoulder or knee surgery, if pulsed electromagnetic field (PEMF) therapy is beneficial in reducing patient-reported post-operative pain, as measured by visual analog scale (VAS). The amount of pain medication taken daily and the physical function outcome scores after surgery and PEMF treatment will also be measured.
Knee Injuries, Shoulder Injuries, Pain, Postoperative
The Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products. Registry data may be used for publications, education and marketing materials, post-market surveillance, future regulatory submissions, research and development for product design, software improvements, and development of artificial intelligence learning and tools.
Orthopedics