Clinical Trials

The overall goal of project is to determine if patients with an endoprosthesis have elevated metal ion levels and if this leads to increased cardiac or neural toxicity based on echocardiograms an neural cognitive testing.

Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.

The objectives of this study are to evaluate changes in pubic symphysis to sacrococcygeal junction distance (PSCD), pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), lumbar lordosis (LL) between three separate evaluations in preoperative candidates for Total Hip Arthroplasty (THA), and to evaluate changes in pubic symphysis to sacrococcygeal junction distance (PSCD), pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), lumbar lordosis (LL) between three separate evaluations in postoperative THA patients.

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.

We plan to analyze patient satisfaction, radiographic outcomes, and complication rates for young patients undergoing primary total hip arthroplasty at ten year follow up. At the current time, little is known about patient outcome in this age group with the above length of follow up.

The purpose of this study is to:

• Determine patient reported outcomes following total hip arthroplasty based on surgical approach.
• Determine if the Forgotten Joint Score (FJS)-12 has superior capability to discriminate outcomes in patients with THA compared to the modified Harris Hip Score (mHHS).

The purpose of this study is to evaluate the correlation between a novel pelvic sensor that assesses spinopelvic motion with lateral sit-to-stand radiographs, and to evaluate the relationship between a novel pelvic sensor with pelvic tilt, sacral slope, and lumbar lordosis.

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.

This is a prospective clinical trial examining only subjects who undergo THA with PSI. The purpose of this study is to compare the alignment accuracy of patient-specific implants versus traditional off-the-shelf implants in total hip arthroplasty using prior literature-derived data as controls.

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.

Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies ...

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 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 learn the effects of synovial fluid, a clear thick joint lubricant, on joint cartilage tissue and the development of osteoarthritis

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.

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 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.

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 analyze all of the variables (eg implant types, duration between procedures, etc) and the effect each had on the long-term outcomes of total wrist arthroplasty.

The purpose of this study is to examine and report nerve injury patterns that occur during shoulder replacement. We will also look at the outcomes of these injuries over time.

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).

The aim of our study is to assess the long-term outcome for patient undergoing anatomic reconstruction of the distal radioulnar joint.

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 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.

The purpose of this study is to determine is the Stablyx ® CMC arthroplasty system provides acceptable outcomes for patients.

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 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.

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 ...

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 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 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 purpose of this study is to compare the outcome of primary anatomic shoulder arthroplasty using the Stryker ReUnion system with implantation of either a peg or keel glenoid construction.

The purpose of this study are to evaluate new MRI software methods to improve imaging near implants. 

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 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.

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 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 the outcomes and complications in patients who have received a hemiarthroplasty, anatomic total shoulder, or reverse total shoulder arthroplasty.

This study is designed to:
-analyze effects of surgical treatment
-improve surgical care and quality of life of patients with hip problems/diseases
-ID predictors of surgical outcomes to identify/improve future treatments
-Collect data, images, from patients undergoing surgical treatment of hip disorders (we will not be collecting social security numbers to send to Washington University).

The purpose of this study is to compare the effectiveness of pain control between a single shot interscalene brachial plexus nerve block, a continuous interscalene brachial plexus nerve block, and a local infiltration analgesia. Total shoulder arthroplasty is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery. The use of interscalene brachial plexus nerve block remains the cornerstone for analgesia following shoulder surgery, however, there has been increasing interest in local infiltration analgesia use for total joint arthroplasty. The benefits of local infiltration analgesia within a comprehensive analgesia clinical pathway have yet to be ...

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

This research study is being done to find out if there is any correlation between metal ion levels (cobalt and chromium) in the fluid around your hip, and those that are found in your blood. One factor that may cause failure of a total hip arthroplasty is an elevated level of these ions around the hip.

The purpose of this study is to:

• Evaluate the influence of the critical shoulder angle (CSA) on outcomes after total anatomic shoulder arthroplasty; and
• Evaluate the influence of the critical shoulder angle (CSA) on rotator cuff failure after total anatomic shoulder arthroplasty.

The purpose of this study is to compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with the implantation of either a large (40 mm) or a small (36 mm) glenosphere (shoulder to arm, ball shaped joint).

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

Aims, purpose, or objectives

Aim 1: To quantify passive stiffness modifications due to RSA in deltoid muscle.

Aim 2: To interpret these modifications in the light of postoperative clinical outcomes.

The aim of this protocol is to determine clinical, functional, radiographic, and survival outcomes in patients undergoing an uncemented reverse total shoulder arthroplasty for a proximal humerus fracture.

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 compare two methods of postoperative pain management for patients who have undergone total knee replacement surgery.

This purpose of this study is to answer if patients fair better with non-operative management or reverse total arthroplasty for treatment of 3- and 4-part proximal humerus fractures.

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.

The primary objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data to better understand the safety and performance of shoulder arthroplasty over time.

The purpose of this study is to evaluate the outcomes of patients who received an Allograft-Prosthesis Composite for Revision of Catastrophic Failure of Ulnar Component of Total Elbow Arthroplasty.

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.

The purpose of this study is to evaluate the outcomes and complications of anatomic total shoulder and reverse total shoulder arthroplasty systems using bone preserving shoulder arthroplasty system.

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.

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.

The purpose of this study is to detect whether arm rotation (pronation vs. supination) affects glenohumeral alignment. If so, does this impact what prosthesis would be used for a shoulder arthroplasty?

The purpose of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

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.

The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3- and 4-part Proximal Humerus Fractures (PHFs) treated nonoperatively or with rTSA. We hypothesize that in displaced 3- and 4-part proximal humerus fractures, rTSA will have better pain relief and functional outcomes than nonoperative treatment.

The purpose of this study is to to assess the clinical and radiographic outcomes of patients who have undergone shoulder arthroplasty.