Scleral Contact Lens Fogging Study
A Study to Evaluate Fogging in Scleral Contact Lens
- Age 18 or older.
- Scleral lens wearers with a history of 6 months of at least 5 hours of scleral lens wear at least 5 days/week are invited to participate.
- Patients with active infections or unstable inflammation of the eyes are not eligible to participate.
- Patients who have been refit into a different scleral lens design during the past 6 months.
- Patients who are actively participating in the scleral lens fitting process.
Variations in Episcleral Venous Pressure
A Study to Evaluate Variations in Episcleral Venous Pressure
- ≥ 35 years of age.
- Either gender.
- Any self-declared ethno-racial category.
- Subjects with two healthy eyes with the crystalline lens, without glaucoma or any other clinically significant eye diseases.
- Open angles in both eyes.
- Intraocular pressure less than 24 mmHg in either eye.
- Be able and willing to provide signed informed consent and follow study instructions.
- Ability to cooperate for the examinations required for study and be able to attend all study visits.
- Contact lenses removed before the study visit.
- Best-corrected visual acuity (BCVA) in each eye of 20/50 or better.
- Female subjects who are pregnant or breastfeeding.
- Narrow angle of < Shaffer grade 2, peripheral synechiae, or peripheral iridotomy in either eye
- Subjects with a central corneal thickness less than 480 µm or greater than 620 µm in either eye.
- Chronic or recurrent inflammatory eye diseases.
- Ocular infection or ocular inflammation in the past 3 months.
- Ocular trauma other than corneal abrasion within the past 6 months.
- Clinically significant retinal disease (e.g., diabetic retinopathy, exudative or severe non-exudative macular degeneration).
- Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity) in either eye.
- Previous intraocular surgery or laser procedure in either eye.
- Previous corneal refractive surgeries.
- Myopia greater than -6.00D, or hyperopia greater than +2.00D.
- Moderate to severe dry eye in either eye.
- Serious hypersensitivity to topical anesthetic eye drops.
- Use of any topical ophthalmic medications other than lubricants and artificial tears within the past 30 days.
- For healthy subjects cohort: Subjects with a history or presence of chronic generalized systemic disease (such as hypertension, diabetes) that may confound the results of the study.
- Systolic blood pressure > 145 mmHg or/and diastolic blood pressure > 95 mmHg.
- For healthy subjects cohort: Subjects who are currently using or have a history of using medications (systemic or topical) that are known to affect IOP or blood pressure within the past 30 days (e.g., systemic/inhaled steroids, α-adrenergic agonists and antagonists, β-adrenergic antagonists, calcium channel blockers, angiotensin converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers).
- Subjects with a history or presence of any systemic condition (e.g., heart failure or kidney disease) for which drinking the water volumes proposed in this study could be harmful (for water drinking test visit).
- For hypertensive subjects cohort: Subjects who are currently using or have a history of using systemic/inhaled steroids within the past 30 days.
- Use of any products of cannabis (THC or CBD compounds) within the past 30 days.
- Lack of suitable episcleral vein for EVP measurement.
- Subjects who are not fully vaccinated against COVID-19.
Eligibility last updated 12/16/21. Questions regarding updates should be directed to the study team contact.
Adrenal Aging in Menopausal Women (Adrenal aging)
A Study to Assess Adrenal Aging in Menopausal Women
- Postmenopausal women with or without history of BSO.
- Willing and able to complete informed consent for this study.
- Already enrolled in IRB#18-008476.
- Ongoing exogenous glucocorticoid therapy.
Cardiovascular Phenotype Driven Genomic Research Exploration Study
A Study to Assess Cardiovascular Phenotype Driven Genomic Research
- Patient with early onset coronary heart disease (CHD)/lipid disorders/other cardiovascular disease (CVD) with suspected/known genetic etiology referred from a clinical provider or found from screening for other research studies.
- Relatives of a patient with a CVD phenotype with suspected/known genetic etiology.
- None.
Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial) (MVP)
A Study to Compare Marrow Venting Procedure Versus PRP
- Age 16-55 years old.
- Medial, lateral, vertical longitutdinal, oblique, or radial meniscal tear.
- Complex tears may be included (investigator discetion) if the patient has one of the tear patterns listed in incluse as the predominant finding.
- No other concomitant procedures unless (one of the following):
- Chondroplasty;
- Synovectomy;
- Loose body removal;
- “Contralateral” menisectomy (i.e., medial meniscus repair with a lateral menisectomy or lateral meniscus repair with a medial menisectomy) would be permitted for inclusion;
- Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure.
- Patients requiring cartilage restorative or repair procedures (i.e., OCD fixation, micro-fracture repair, or others).
- Patients with meniscus root tears.
- Patients undergoing repair for horizontal cleavage tears.
- Kellgren-Lawrence scale > 2.
- Patients undergoing lateral release.
- Ipsilateral chondral lesion with Outerbridge classification of 3-4.
- Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery.
- Cortisone use within the six weeks prior to surgery.
- Utilizing worker’s compensation at the time of screening.
- Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
- Concomitant ligamentous insufficiency.
- Inflammatory rheumatic disease or other rheumatic disease.
- Immune compromised patients (hepatitis, HIV, etc.).
- Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc.).
- History of distal femur, proximal tibia, or patellar fracture that was treated operatively.
- Non English-speaking patients.
Post-Intensive Care Syndrome – Pediatrics (PICS-p): Longitudinal Cohort Study (PICS-p)
A Study to Assess Post-Intensive Care Syndrome – Pediatrics
- Current admission is the child’s first PICU admission.
- Patient age ≥ 4 weeks and ≥ 44 weeks corrected gestational age, and < 16 years (has not yet reached 16th birthday) on PICU admission.
- At least one parent/legal guardian (≥ 18 years of age or considered emancipated) living with the potential subject.
- PICU LOS of ≥ 3 days (covering at least 3 nights from midnight to 7am) in which the patient received intensive care therapies for organ dysfunction (invasive mechanical ventilation, vasopressors/inotropes, acute renal replacement therapy, or other extracorporeal therapies).
- Anticipated patient discharge to home (direct or indirect).
- Patient history of neonatal intensive care unit hospitalization.
- Life expectancy not anticipated to be more than one year (e.g., active do not resuscitate [DNR] plan or actively managed by the palliative care team for end-of-life symptom management).
- Patient in foster care or ward of the state.
Eligibility last updated 10/18/21. Questions regarding updates should be directed to the study team contact.
Risk Factors for False Positive HIV-2 testing (FPHIV)
A Study to Assess False Positive HIV-2 Testing
- Individuals ≥ 18 years of age.
- False positive HIV 2 test with a positive or indeterminate HIV2 antibody test and negative PCR testing.
- Must have been seen in the Mayo Clinic Infectious Disease/HIV Clinic
- Individuals < 18 years of age.
Clinical Pilot of Augmented Human Intelligence in Major Depressive Disorder (AHI/Depression Pilot)
Augmented Human Intelligence in Major Depressive Disorder
- Outpatients with nonpsychotic MDD. Outpatient status assumes that the subject is not psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization.
- A total score of > 10 on the QIDS-CR and on the QIDS-SR (equivalent to a HAMD17 score of 13 [ids-qids.org, accessed on April 12, 2019]) given that when medication exceeds the effect of placebo in primary care, participants have a 17-item HAMD score > 12. We added 2 HAMD points to take into account the possibility of measurement error. This is a very similar approach taken to the successful recruitment of subjects into the PGRN-AMPS trial.
- Antidepressant treatment is deemed appropriate by the study clinician.
- Adults who are between 18-64 years of age.
- Ability to provide informed consent
- Ability to understand English.
- A medical contraindication that precludes SSRI or SNRI treatment.
- Presence of a general medical condition that, in the opinion of this study clinician, is the cause of their depressive symptoms, will be exclusionary.
- People with treatment-resistant depression will be excluded from participating. For this study, treatment resistance will be defined as failure to respond to two or more adequate therapeutic trials of SSRIs and at least on SNRI therapeutic trial (sufficient antidepressant dose, for 6 weeks or longer) during the current depressive episode. Failure to tolerate a therapeutic trial of a given medication (resulting in discontinuation due to adverse effects) will not be counted as exclusionary. Persons who have failed to respond to two or more adequately designed and executed therapeutic trials of SSRIs but have no history of least one failure to respond to SNRI treatment during the current depressive episode will be eligible to receive treatment with an SNRI in this study.
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II disorder, or bipolar disorder NOS (including other specified or other unspecified bipolar disorders) or a primary psychiatric condition that requires a different initial treatment than an antidepressant.
- Currently taking an antidepressant medication with subtherapeutic results in terms of antidepressive efficacy and unwilling to undergo a medication taper and discontinuation prior to initiation of a study drug from this protocol. The subject will be closely monitored by the study clinician during the medication taper and discontinuation phase. The design of the medication taper will be at the discretion of the study clinician. Subjects who cannot be safely tapered from their medication or who experience adverse effects during the taper that make further tapering infeasible will be excluded from the study.
- Use of antidepressant medication primarily for management of nicotine dependence, chronic pain, migraine prophylaxis or other diagnoses.
- Active substance use disorder. Persons in sustained full remission (> 12 months) and a negative urine drug of abuse screen at the screening visit will be considered eligible.
- Note: An additional urine drug screen will not be necessary for individuals with a negative urine drug screen documented in the medical record where the date of testing occurred within 12 weeks (84 days) of the screening/ baseline study visit. However, study clinicians can still obtain a urine drug screen based on their clinical judgement even in participants with a negative drug screen within the 12 weeks preceding the screening/baseline study visit.
- Trazadone, melatonin, low-dose quetiapine (< 100 mg QHS), z-drugs (zolpidem, zopiclone, eszopiclone, etc.), ramelteon, and diphenhydramine may be used as rescue medications for insomnia. Benzodiazepines may be used for treatment of anxiety, and atomoxetine may be used for the treatment of attention deficit disorder. Study subjects currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs, other than low-dose quetiapine for insomnia) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine) are not eligible for the study
- Pregnant subjects and those who are currently breastfeeding and who plan to continue breastfeeding will be excluded.
- Persons currently undergoing ECT, TMS or DBS as acute series or for maintenance.
- Patients currently psychiatrically hospitalized or in an active suicidal crisis requiring hospitalization in the opinion of the study clinician.
- As an additional stipulation, individuals whose total QIDS-CR and total QIDS-SR scores are 10 or higher at the screening visit but decrease (improve) to total scores less than 10 on either the QIDS-CR or QIDS-SR at the baseline visit will be excluded.
Manipulation Under Anesthesia After Bilateral Primary Total Knee Arthroplasty; Characterization of Genetic Profile
A Study to Evaluate Manipulation Under Anesthesia After Bilateral Primary Total Knee Arthroplasty
- Age > 18 years old.
- Primary total knee performed, 2000-2019.
- Development of knee stiffness requiring manipulation under anesthesia.
- Primary surgery and manipulation performed at Mayo Clinic Rochester, MN.
- Age < 18 years old.
- Pregnant women.
Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient TJA
- Adult patients age ≥ 18.
- Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.
- Individuals < 18 years of age.
Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.
Assessment of Novel Hyperphagia Questionnaires to Identify Variants in MC4R Pathway-Associated Obesity
Identifying Variants in MC4R Pathway-Associated Obesity With Novel Hyperphagia Questionnaires
- Patients who are or will be included in POWER registry.
- Patients aged 6 to 26 years at time of recruitment for the current study.
- Patients who satisfy the criteria for early-onset obesity:
- Criteria to identify early-onset obesity among patients aged 6 to 26 years will be consistent with the criteria used for the Uncovering Rare Obesity® Program, as follows:
- For patients aged 6 to 18 years at study recruitment::
- The patient’s body mass index (BMI) is ≥ 97th percentile at recruitment based on the Centers for Disease Control (CDC) charts, and;
- The patient has early-onset obesity.
- Early-onset obesity will be determined based on historical records of weight, height, age, and gender in the electronic medical record or patient chart using the following definitions:
- Historical measurements from age < 2 years: sex-specific weight for recumbent length is ≥ 97.7th percentile on the World Health Organization (WHO) charts.
- Historical measurements from age 2-5 years: BMI ≥97th percentile based on the CDC charts.
- Only patients with verified weight and height information before the age of 6 years and who meet the criteria of early-onset obesity will be included in the study. For new patients without available measurements to confirm early-onset obesity (electronic medical record, patient chart and/or POWER data), at least 1 weight and height measurement prior to the age of 6 years will be obtained by the study investigator at each participating site (either from the electronic medical record or from the patient’s primary care provider).
- For patients aged ≥ 18 years at study recruitment:
- The patient’s BMI is ≥ 40 kg/m^2 at recruitment AND
- The patient has early-onset obesity (as defined above), as documented in the electronic medical record or patient chart.
- Criteria to identify early-onset obesity among patients aged 6 to 26 years will be consistent with the criteria used for the Uncovering Rare Obesity® Program, as follows:
- Patients with prior testing for variants in the 36 genes of interest.
- Patients who have any of the following potential causes of secondary obesity:
- Endocrine diagnoses (e.g., hypothyroidism, Cushing syndrome, growth hormone [GH] deficiency);
- Neurologic diagnoses.;
- Intracranial injury (including, but not limited to: tumor, trauma, surgery, pituitary resection, irradiation);
- Hypothalamic obesity;
- Medication-induced weight gain, as determined by the Investigator.
Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.
A Study to Evaluate Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
- Adults with obesity (BMI > 30Kg/m^2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
- Age: 18-75 years old.
- Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
- Women of childbearing potential must agree to use a method of effective contraception during study participation.
- Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.
- History of Abdominal bariatric surgery.
- Weight is greater than 450 lbs. (204 kg).
- Recent use (within the last three months) of any antiobesity medication.
- Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months).
- Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score > 11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
- Hypersensitivity or contraindication to the study medication.
- Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
- Principal Investigator discretion.
Laboratory Methodology Development - Muscle
A Study to Test How Muscle Tissue Differs Between People
- Adults 18 – 65 years old
- Volunteer who have history of bleeding tendencies
Measuring Social Facial Perception Using Eye-Tracking
A Study to Measure Social Facial Perception Using Eye-Tracking
Casual Observers
- 18 years or older.
- Normal eye movements and binocular vision (with or without correction).
- Ability to speak and read English.
- Age less than 18 years old.
- Eye movement limitations such as spontaneous nystagmus or strabismus.
- Monocular vision.
- Psychiatric condition as studies have shown that individuals with psychiatric conditions (particularly schizophrenia and autism spectrum disorder) result in altered visual attention to the face.
- If casual observers respond yes to these questions they will be thanked for their interest and excluded from the study
Patients
Nicotine Concentrations During Hookah Smoking Sessions in Regular Hookah Smokers
A Study to Evaluate Nicotine Concentrations in Regular Hookah Smokers
- Smokers of Hookah (shisha tobacco).
- 18 years of age or older.
- Able to participate fully in all aspects of the study.
- Understand and verbally consent to participate in the study.
- Has the ability to have 25 cc of blood drawn over the course of 2 hours through a catheter.
- Study subjects not meeting the Inclusion Criteria above.
Describing Discomforts Among Intensive Care Unit Patients
A Study to Identify Discomforts Among Intensive Care Unit Patients
Inclusion Criteria:
- English s.peaking
- Willing and able to communicate and participate.
- ≥ 18 Years of Age.
- Admitted to one of the ICUs described in the Setting section.
- ICU admission > 24 hours.
- CAM-ICU negative (delirium absent), RASS 0 (calm and cooperative) as documented by the patient-care nurse during the most recent documented assessment that calendar day.
- Non-English speaking.
- Not willing to communicate or participate.
- < 18 years of age.
- CAM-ICU positive (delirium present) or RASS other than 0 (Not calm and cooperative) as documented by the patient-care nurse during the most recent documented assessment that calendar day.
- Not admitted to one of the ICUs described in the Setting section.
- ICU admission < 24 hours.
- Documented as a threatening/verbal abuse.
- Documented cognition or communication problems (i.e., admission for treatment of active substance abuse/withdrawal, codependence, Traumatic Brain Injury, developmental delay, Alzheimer’s disease, dementia).
- Prisoners.
Early Onset Osteoarthritis in Nondysplastic Hips: A Prospective Data Collection
A Study to Evaluate Early Onset Osteoarthritis in Nondysplastic Hips
- All patients seen by Doctor Rafael Sierra and Robert Trousdale in clinic.
- Between the ages of 12 and 65 years of age.
- Individiuals under the age of 12 and over the age of 65 years.
Hereditary Eye Disease Study
Hereditary Eye Disease Study
- Subjects with hereditary eye disease.
- Subjects with a family history of hereditary eye disease.
- Subjects without hereditary eye disease and no family history of hereditary eye disease who would serve as a control in specific case-control experiments.
- Ability to understand and willingness to sign the informed consent documents.
- Unable or unwilling to sign or understand the informed consent documents.
- Unwilling to participate in the research.
- Unwilling to allow genetic testing.
- Unwilling to allow samples to be sent to other institutional for testing.
- Not meeting the inclusion criteria.
CHIlled Platelet Study (CHIPS)
CHIlled Platelet Study "CHIPS"
- Age greater than 28 days and less than 85 years.
- Planned complex cardiac surgery with planned use of cardiopulmonary bypass.
- Expected order for washed or volume reduced platelets.
- Patient with known anti-platelet antibodies.
- Platelet transfusion refractoriness due to anti-HLA antibodies.
- Known or suspected pregnancy.
- Previously randomized in this study.
- Conscious objection or unwillingness to receive blood products.
- Known IgA deficiency.
- Known congenital platelet disorder.
- Known congenital bleeding disorder.
- Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis.
- Patients intended to receive whole blood either intra-operative or post-operative for bleeding.
- Platelet transfusion (of any type) within 24 hours prior to receiving study platelets.
- Pre-operative thrombocytopenia.
Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.
Childhood ADPKD Database Study
Childhood ADPKD Database Study
- Diagnosed with ADPKD prior to 18 years of age.
- Demonstration of ADPKD by clinical information, imaging studies, biopsy, autopsy, or genetic testing.
- Patients with autosomal recessive polycystic kidney disease (ARPKD), urinary tract malformations or major congenital anomalies of other systems suggesting a diagnosis other than recessive hepato-renal fibrocystic diseases.
Can a Novel 4D Needle Positioning Technology Improve Performance in Simulated Central Venous Catheterization
A Study to Evaluate if a Novel 4D Needle Positioning Technology Can Improve Performance in Simulated Central Venous Catheterization
- Medical students and interns of the department of general surgery with experience of having placed <5 central venous catheters.
- Participants who do not consent to participate in the study.
Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
A Study to Assess Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
- ≥ 18 years old.
- Primary diagnosis of spinal stenosis.
- Surgical indication for 1 or 2 level posterior spinal decompression or fusion.
- Previous posterior spinal surgery.
- Systemic corticosteroid use.
- Long-term anticoagulation treatment.
- Diagnosis of diabetes mellitus.
- Diagnosis of peripheral arterial disease.
- Current smoker.
- Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis.
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
• Age 18-75 years
• SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
• MAP >65 mmHg on <3 vasopressors/inotropes at the time of consent
• Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
• VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
• CS due to other (non-ACS) etiologies
• Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO
• Profound vasoplegia with MAP <65 mmHg on 3 vasopressors/inotropes
• Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
• Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
• Bleeding complications requiring ongoing transfusions of blood products
• Ischemic lower extremities
• Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
• Evidence of sepsis or septic shock
• Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)
Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care (QTc)
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
- Infants (Day 0
•5 years). - Long QT Syndrome(LQTS).
- Newborns without LQTS (Controls).
- Parental willingness to provide informed consent and follow the study protocol.
- Children > 5 years old.
- Those with genetically elusive LQTS.
- Infants with congenital heart disease.
- Infants born < 32 weeks EGA.
- Patients with a cardiac device implant (pacemaker/ICD).
TORNIER PERFORM™ Stemless Reverse IDE Study (TORNIER PERFORM™ Stemless Reverse IDE Study)
TORNIER PERFORM™ Stemless Reverse IDE Study
- Adult subject 18 years or older.
- Scapula and proximal humerus must have reached skeletal maturity.
- Clinical indication for reversed TSA due to: non-inflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, functional deformity, post-traumatic arthritis, and/or rotator cuff tear arthropathy.
- Willing and able to comply with the protocol.
- Willing and able to sign the informed consent form.
- Patients with an adjusted Constant Score ≤ 65.
- Active local or systemic infection, sepsis, or osteomyelitis.
- In the opinion of the clinician, there is inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
- In the opinion of the clinician, there is poor bone quality where there could be a considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
- In surgeon’s opinion, rotator cuff tear requires a latissimus dorsi transfer.
- In the clinician’s opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
- Metabolism disorder that could compromise bone formation, or Osteomalacia.
- Rapid destruction of the joint, marked bone loss, or bone resorption apparent on imaging.
- Known allergy or suspected allergy to the materials.
- Female subjects who are pregnant or planning to become pregnant within the study period.
- Medical condition(s) or balance impairments that could lead to falls (e.g., epilepsy not well-controlled with medication, Multiple Sclerosis, etc).
- Previous failed arthroplasty.
- Nonfunctional deltoid muscle.
- Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
- Known active metastatic or neoplastic disease, Paget’s disease or Charcot’s disease.
- Currently, or within the last six months, or planning to be on chemotherapy or radiation.
- Recent or ongoing alcohol or drug abuse as determined by the investigator.
- Taking > 5mg/day corticosteroids (e.g., prednisone), excluding inhalers and one-time injections, within three months before surgery.
- Currently enrolled in any clinical research study that might interfere with the current study.
- Known history of severe depression.
- Primary insurance is Workers’ Compensation.
- The study has completed 109 implant attempts for the randomized treatment arm.
- Sequela of proximal humerus trauma requiring greater tuberosity osteotomy during RSA.
- Chronic shoulder dislocation with or without fracture, > 6 weeks.
- Parkinson’s disease.
Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.
Arthrex Primary Total Knee and Unicondylar Knee Registry
A Study to Collect Clinical Outcomes in Patients after Knee Arthroplasty
Subjects who meet ALL of the following criteria may be included in the study.
- Subjects that are candidates for primary arthroplasty, and will be surgically treated using TKA or UKA prosthesis systems with Vitamin E polyethylene manufactured by Arthrex.
- The subject voluntarily consents to participate in the study and signed the IRB approved informed consent form prior to enrollment
- The subject is eighteen (18) years of age or older
- The subject can comply with all post-operative evaluations, visits, and completion of subjective questionnaires.
- Non inflammatory osteoarthritis
Subjects will be excluded from the study if they present with ANY of the following:
- Workman’s compensation cases
- Previous distal femoral or proximal tibial osteotomy including tibial tubercle osteotomy procedure
- Pre-existing hardware that requires removal except cruciate ligament hardware
- BMI > 40
- Varus/Valgus deformity > 15 degrees from mechanical axis
- Blood supply limitations and previous knee infections, which may retard healing
- Foreign body sensitivity
- Conditions that tend to limit the subject's ability or willingness to restrict activities or follow directions during the healing period
- Concomitant procedure with UKA
Scoliosis Outcomes Database Registry (AIS)
A Study to Establish An Adolescent Idiopathic Scoliosis Outcomes Database Registry
Inclusion Criteria
•Database Registry:
- Patients aged ≤ 26 years who present with a curve large enough that a definitive fusion for idiopathic scoliosis would be considered an option.
- Male or female.
- Diagnosis of idiopathic scoliosis for which definitive fusion surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
- Curve cobb of any magnitude – operative range.
- Spina bifida Oculta is permitted.
- Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
- Non-operative idiopathic scoliosis patients:
- Aged ≤ 26 years, male or female, curve cobb of ≥40º, whom elected not to proceed with surgery; or
- Aged ≤ 26 years, male or female, Curve cobb ≥ 30º and approaching skeletally mature (defined as Age: girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 or sanders ≥7).
Execlusion Criteria
•Database Registry:
- Prior spinal surgery.
- MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
- Neuromuscular or other serious co-morbidities.
- Thoracogenic or cardiogenic scoliosis.
- Associated syndrome or developmental delay.
- Unable or unwilling to firmly commit to returning for required follow-up visits.
Minimal Residual Disease in Chronic Lymphocytic Leukemia
A Study to Evaluate Minimal Residual Disease in Chronic Lymphocytic Leukemia
- Age 18+ Years Old.
- Diagnosis of Chronic Lymphocytic Leukemia (B-CLL).
- Pregnant.
Visual Function in Fuchs Endothelial Corneal Dystrophy
A Study to Evaluate Visual Function in Fuchs Endothelial Corneal Dystrophy
- Fuchs Endothelial Corneal Dystrophy (FECD): Presence of central or paracentral corneal guttae with or without corneal edema. (Controls will not have any guttae).
- Any age (expected range will be 40-90 years).
- Any sex or race.
- Subjects who have previously undergone uncomplicated cataract surgery (to eliminate the confounding effect of cataract on vision) at least 2 months prior to enrollment.
- Any ocular disease that is known to affect vision (e.g., cataract, macula/retinal disease, amblyopia, etc.).
- Previous corneal transplantation in both eyes.
Aqueous Outflow Facility Following Scleral Buckle Surgery
A Study to Evaluate Aqueous Outflow Facility Following Scleral Buckle Surgery
- Adults, ≥ 18 years of age.
- Willing and able to provide informed consent.
- Patients who have undergone unilateral scleral buckle only surgery (i.e., no vitrectomy) with a 360° encircling band.
- Individuals < 18 years of age.
- Diagnosis of glaucoma or glaucoma suspect.
- Unilateral ocular hypertension.
- Difference in lens status (i.e., pseudophakic vs phakic) between the two eyes.
- Preoperative (pre-buckle) anisometropia > 2.5 D.
- Current use of steroid medications (oral, topical, inhaled, injected, or other).
- Use of IOP-lowering medications.
- Active or chronic uveitis.
- Diseases or processes which affect the iridocorneal angle, including but not limited to neovascular glaucoma, iridocorneal endothelial syndrome, peripheral anterior synechiae, etc.
- Monocular status (enucleated or phthisical fellow eye, or fellow eye with visual acuity less than 20/100).
- History of previous vitreoretinal surgery in either eye.
- Inability to lay completely supine for the required time period.