Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 50 years or older
• People who are a patient of Dr. Howard Hirsch or Dr. Vinod Dasa and are scheduled for a total knee replacement surgery at Ochsner Kenner
• People who plan to receive all of their post-surgery physical therapy as an outpatient at OTW Driftwood
• People who speak English
• People who have been diagnosed with osteoarthritis (the common "wear and tear" type, not caused by another disease)

Who may not be able to join:

• People who regularly use opioid (strong prescription painkiller) medications on an ongoing basis
• People who have used opioid medications at any point in the last 3 months
• People who score 30 or higher on a pain catastrophizing questionnaire (a tool that measures how someone thinks and feels about pain — confirm with trial site)
• People diagnosed with an inflammatory joint or autoimmune condition, such as gout, rheumatoid arthritis, or lupus
• People who will be discharged to a skilled nursing facility after surgery rather than going home
• People who have a medical condition that causes sensitivity or bad reactions to cold, such as Raynaud's disease
• People who have significant problems with blood flow in the leg being treated
• People who currently show signs of vein inflammation, leg ulcers, or skin infection (cellulitis) in the affected area
• People who have significant risk factors for, or current signs of, blood clots travelling through the body — such as a history of pulmonary embolism, heart attack, atrial fibrillation, stroke, or similar conditions
• People who have a condition where increasing fluid return through the veins or lymphatic system in the affected limb is not medically advisable — for example, lymphedema following breast cancer, or cancer that has spread to the affected limb
• People with uncontrolled high blood pressure (as determined by their doctor), heart failure, extremely low blood pressure, or poorly managed heart function
• People with unstable skin conditions in the affected area, such as severe dermatitis, gangrene, or a recent skin graft
• People who have recently had toe surgery on the same side as the affected leg
• People who currently show signs of significant swelling-related conditions in the affected limb, such as deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, congestive heart failure-related swelling, liver failure, or kidney failure
• People who have an untreated or unstable bone fracture in the affected area
• People who currently have any active infection, either in one area of the body or throughout the body
• People who are not fully alert, or who have diabetes, multiple sclerosis, poor circulation, spinal cord injuries, or rheumatoid arthritis
• People who have areas of broken, damaged, or at-risk skin in the affected region that could affect how cold is conducted across the skin (such as open wounds, scar tissue, burns, or skin grafts)
• People with signs or a diagnosis of congestive heart failure
• People with a pre-existing deep vein thrombosis (a blood clot in a deep vein)
• People with a history of blood clots forming in deep veins (phlebothrombosis)
• People with a history of blood clots travelling to the lungs (pulmonary embolism)
• People with fluid build-up in the lungs (pulmonary edema)
• People with acute inflammation of the veins (thrombophlebitis)
• People with poorly managed or severe heart function problems
• People with arterial regulation problems affecting blood flow (confirm with trial site)
• People with erysipelas (a type of bacterial skin infection)
• People with cancer or cancer that has spread to the affected limb
• People with severely uncontrolled high blood pressure
• People with acute inflammatory skin diseases or active skin infections
• People with disease causing blockage of veins or arteries
• People in medical situations where increasing fluid return through veins or the lymphatic system is not advisable
• People with poor circulation in the outer parts of the body
• People with severe hardening of the arteries or any active infection
• People with known blood disorders that increase the risk of clotting, such as paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle cell disease, or cold agglutinin conditions
• People whose tissues are inflamed due to a recent injury or a flare-up of a long-term inflammatory condition
• People with reduced blood flow or nerve function in the affected area, including due to paralysis, multiple surgeries, or diabetes
• People who have difficulty with thinking, understanding, or communicating in a way that would prevent them from giving accurate and timely feedback during the trial
• People with a known allergy to cold
• People with cold agglutinin disorders such as paroxysmal cold hemoglobinuria
• People with Buerger's disease (a condition affecting blood vessels in the limbs)
• People with chilblains (painful skin reactions caused by cold exposure)
• People with cryoglobulinemia (a blood condition triggered by cold)
• People with sickle cell anaemia
• People with uncontrolled diabetes (as determined by their doctor)
• People with a known sensitivity or hypersensitivity to cold
• People with a history of cold-related injury (such as frostbite)
• People with severe heart or cardiovascular disease, reduced skin sensation, blood clotting disorders, poor circulation, extreme sensitivity to pain in the limbs, very low blood pressure, reduced skin sensitivity, a history of vein ligation or recent skin grafts, or a tumour of the adrenal gland (pheochromocytoma)

Important: Always verify eligibility with the trial site directly before applying.