Clinical Trials

The purpose of this study is to determine the best dosing plan and route of administration of tranexamic acid to minimize post-operative blood loss and transfusion requirements after a redo of a total knee replacement surgery.

The prevalence of chronic pain following total knee replacement has been under studied.  In recent years, the perioperative use of multimodal analgesic strategies including regional anesthetic techniques has substantially improved early postoperative pain management. However, it is not clear that these improvements in perioperative care have reduced the frequency of chronic pain post-total knee replacement.  This study will conduct a cross sectional study to determine the prevalence of chronic knee pain following total knee replacement up to 5 years postoperatively.  This study will also identify risk factors, such as smoking, depression, and pain problems elsewhere as predictors of chronic knee pain after knee ...

The purpose of this study is to evaluate the hypothesis that the investigators current total joint regional anesthesia pathway of continuous femoral nerve block plus single-injection sciatic block with multimodal analgesia (MC1156-462rev0114) is more effective than two other pathways utilizing periarticular local anesthesia injections for numeric rating score (NRS) of pain with movement after total knee arthroplasty (TKA) on postoperative day 1 morning. The periarticular injections include one consisting of ropivacaine and the other consisting of liposomal bupivacaine (Exparel).

This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.

The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.

This study aims to assess pre- and postoperative serum mast cell tryptase levels in primary TKA patients to determine whether there is an association with the development of post-operative stiffness.

What is the difference in the outcomes of patients treated with an articulating antibiotic spacer versus a static articulating spacer in the setting of two stage exchange for an infected total knee arthroplasty?

The purpose of this study is to compare the outcome following manipulation under anesthesia for stiffness with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone. Measured outcomes will include pain, range of motion, as well as subjective outcome scores.

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

The purpose of this study is to gather initial data for pain biomarker discovery in humans with correlation to clinical outcomes. Additionally, the study will test the hypothesis that the analgesic mechanism of acetaminophen in humans relies on the serotonergic and endocannabinoid system. 

The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.

The purpose of this study is to determine unique genetic profile of patients requiring MUA following bilateral pTKA via genetic sequencing, to determine outcomes of patients receiving MUA in terms of KSS, implant durability, survival free of reoperation, and to define characteristics and comorbidities of patients undergoing unilateral and bilateral MUA.

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at obtaining adequate tissue levels of the antibiotic than the current standard dose which is given intravenously (IV) through a wrist vein. The use of IORA vancomycin requires the use of a tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery with tourniquet use minimised or without a tourniquet at all. The aim of this study is to evaluate whether IORA vancomycin can achieve ...

The purpose of this study is to investigate if bupivacaine +meloxicam ER solution is going to improve patient care at Mayo Clinic through superior and prolonged analgesia following total knee arthroplasty compared to our standard of care.

The purpose of this study is to evaluate the incidence of chronic knee pain at 6 months following primary total knee arthroplasty. Secondary outcomes include incidence of knee numbness, postoperative sensory loss or change at the knee, range of motion (ROM), resting pain with Visual Analog Scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), quality of life measurement assessed by SF-36.

This study aims to compare postoperative pain levels between three (3) treatment groups, using the Numerical Rating Scale (NRS).

The purpose of this study is to prospectively collect and compare functional scores for patients who underwent total knee arthroplasty with the Conformis iTotal knee versus off-the-shelf total knees performed at Mayo Clinic Florida by the same surgeons over the same period.

The purpose of this study is to determine the most efficient and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

The aim of this study is to evaluate the incidence of infrapatellar branch of the saphenous nerve encounters during the standard medial parapatellar approach to the knee during arthroplasty.

The purpose of this study is to determine when patients have returned to driving a car following total joint arthroplasty and whether or not they were involved in a car accident after their return to driving.

The purpose of this study is to find out whether knee joint fluid (synovial fluid) contains substances which may interfere with laboratory tests not normally done on synovial fluid. 

The purpose of this study is to learn the effects of synovial fluid, a clear thick joint lubricant, on joint cartilage tissue and the development of osteoarthritis

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

The purpose of this study is to assess predictive value or correlation of outcome measures results on patients following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to that patient population.

To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).

This project is focused on understanding the risk of cognitive impairment and dementia in total hip and total knee arthroplasty patients. It involves 4 aims:

AIM 1. To determine the risk of dementia in patients with TJA. Using the REP, we will identify a population-based cohort of 9,000 TJA patients and a matched cohort of 9,000 non-TJA patients. The overall risk of dementia and subtypes will be compared between the two cohorts.

AIM 2. To determine cognitive function and neuroimaging measures in patients with TJA. Within the existing data from the MCSA cohort (IRB: 14-004401), we ...

Of the three most commonly/routinely performed surgical technique of patellar resection during total knee arthroplasty performed at the Mayo Clinic, which results in the most symmetrically resected patella (knee-cap)?

The purpose of this study is to evaluate two different standards of care to see if the single Double Debridement, Antibiotics and Implant Retention (DAIR) protocol is non-inferior to planned double-DAIR protocols for acute Periprosthetic Joint Infection (PJI) after primary total hip arthroplasty (THA) or  total knee arthroplasty (TKA). Additionally, effectiveness of treatment in terms of infection eradication and cost comparisons will be addressed.

The purpose of this study is to evaluate time to return of lower extremity motor function following mepivacaine versys low-dose bupivacaine spinal anesthetic among patients undergoing primary total hip arthorplasty (THA) and total knee arthroplasty (TKA).

The purpose of this study is to determine the incremental value of a “star” from the patient perspective when choosing a provider for total joint replacement.

This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.

The purpose of this study is to look at the use of pharmacogenomic data in the perioperative period to guide drug therapy in patients undergoing total knee arthroscopy.

The objective of the study is a multi-center prospective registry to collect clinical outcomes of  knee arthroplasty.

The purpose of this study is to determine if  medically contained (MC) total knee arthoplasty (TKA) achieves similar patient satisfaction at 1-year follow-up compared to posterior stabilized (PS) TKA.

The purpose of this study is to evaluate the orthopedic patients’ perspective on the use of indwelling foley catheters.

The purpose of this study is to compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the non-opioid treatment group.

The study aim is to conduct a clinical research investigation to compare two alignment techniques used in contemporary total knee arthroplasty by means of a prospective non-randomized clinical trial. The two alignment techniques are Kinematic Alignment (KA) and Mechanical Alignment (MA).

This study seeks to evaluate the difference in clinical, radiographic and functional outcomes between ultracongruent, medial pivot and posterior stabilized TKA bearings in a retrospective cohort.

Total knee arthroplasty (TKA) is a reliable and durable procedure. In contemporary TKAs, there are mutliple bearing options, the benefits of which remain unclear.

The purpose of this study is to determine the effectiveness of Next Science® Xperience™ Advanced Surgical Irrigation in reducing bacterial bioburden and acute periprosthetic joint infection rates after total hip and knee arthroplasty compared to standard of care irrigation.

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Revision TKA for instability is fairly common occurring in up to 22% of revision procedures. Previous reports of revision TKA for flexion instability are limited in the length of follow-up as well as the number of patients. There is a paucity of studies with large series of total knee arthroplasty patients revised for flexion instability with midterm and long-term follow-up. The purpose of this study is to present the Mayo Clinic series of revision TKA patients with flexion instability and present the clinical outcomes including survivorship, complications, reoperations as well as patient reported and radiographic outcomes at mid- ...

The purpose of the study is to determine the survivorship, clinical outcomes, and mechanisms of failure associated with total hip and knee arthroplasty in patients with osteogenesis imperfecta.

The purpose of this study is to evaluate if there is a decrease in blood flow to the incision following application of an ice pack.

The purpose of this study is to assess the impact of a whole food plant-based diet on blood sugar control in diabetic patients versus a control group on the American Diabetics Association diet before having a total hip, knee, or shoulder replacement surgery.

The purpose of this study is to validate the patient approved knee assessment (PAKA) by providing the questionnaire to patients to assess patient needs, formulate a questionnaire based on this information, and finally validate the questionnaire in assessing the same outcomes as existing questionnaires for clinical use.

The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. This study seeks to understand the difference between two different education delivery methodologies and the effect on the postoperative pain experience, including participation in treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved pain associated outcomes and higher patient participation when compared to the current standard education delivery method.

The purposes of this study are to determine:  the risk of cardiomyopathy and heart failure, and cardiac structure and function in patients with THA and TKA. This study will also determine the association between serum and/or synovial fluid metal ion levels with cardiac structure and function in 100 prospectively-recruited THA and TJA patients.

The purpose of this study is to learn why there are differences between those who develop stiff joints and those who do not by examining the genes responsible for joint contractures in people who have had total joint surgery.

The purpose of this study is to evaluate the clinical outcomes, survivorship, and complications of HIV-positive patients undergoing total hip or total knee arthroplasty at the Mayo Clinic in the past 20 years.

The primary aims of this study are to determine whether extended oral prophylactic antibiotics after primary total joint arthropasty (TJA) decreases the incidence of periprosthetic joint infection (PJI) in a high-risk patient population, and to determine whether extended oral prophylactic antibiotics after primary TJA decreases the incidence of surgical wound complications in a high-risk patient population.

The purpose of this study is to assess the reliability of a single question with a yes or no answer, as a measure of outcome following recovery from total hip or knee replacement.

This study is being conducted to determine gene and protein expression profiles (i.e. which genes and proteins are turned off and on) of those with a possibility of developing osteolysis, infection, arthrofibrosis or metallosis of their THA/TKA.

The purpose of this study is to compare two methods of postoperative pain management for patients who have undergone total knee replacement surgery.

The objectives of this study are to produce an allogeneic cartilage bank whereby cartilage tissue is obtained from consented donors who meet 21 CFR 1271 donor eligibility criteria, and to simluate clinical implantation of living donor osteochondral allografts banked from Aim 1, demonstrated to meet both viability and sterility requirements, in patients undergoing osteochondral transplantation in the Mayo clinical practice. Actual grafting using collected cartilage will not occur. This is a process validation study.

We will collect both non-invasive hemoglobin and conventional serum hemoglobin labs from patients postoperatively following outpatient total joint arthroplasty to determine how closely the values of these two studies correlate in the outpatient total joint arthroplasty patient population.