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New treatment option for Primary Osteoarthritis Patients Scheduled for Total Knee Replacement...
Official title Cold and Compression Post TKA
ClinicalTrials.gov ID: NCT07023185
What this study is testing
- What it's testing
- The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Aged 50 yr or older
- Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner
- Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
- English speaking
- Diagnosis of primary osteoarthritis
You likely can't join if
- Chronic opioid use
- Opioid use within the last 3 months
- PCS score ≥ 30
- Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
- Discharge to skilled nursing
- Cold intolerance related to diseases, like Raynaud's
See the full eligibility criteria
- Aged 50 yr or older
- Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner
- Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
- English speaking
- Diagnosis of primary osteoarthritis
- Chronic opioid use
- Opioid use within the last 3 months
- PCS score ≥ 30
- Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
- Discharge to skilled nursing
- Cold intolerance related to diseases, like Raynaud's
- Significant vascular impairment in the affected region
- Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
- Significant risk factors or current clinical signs of embolism (e.g., pulmonary embolus, pulmonary edema, cerebral infarction, atrial fibrillation, endocarditis, myocardial infarction, or atheromatous embolic plaque)
- A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).
- Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
- Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
- Had recent toe surgery in the affected region
- Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart...
- An acute, unstable (untreated) fracture in the affected region.
- Any active local or systemic infection.
- Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
- Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Polar...
- Presumptive evidence of congestive heart failure
- Pre-existing DVT condition
- Deep acute venal thrombosis (Phlebothrombosis)
- Episodes of pulmonary embolism
- Pulmonary edema
- Acute inflammation of the veins (Thrombophlebitis)
- Decompensated cardiac insufficiency
- Arterial dysregulation
- Erysipelas
- Carcinoma and carcinoma metastasis in the affected extremity
- Decompensated hypertonia
- Acute inflammatory skin diseases or infection
- Venous or arterial occlusive disease
- Medical situations where increased venous or lymphatic return is undesirable
- Poor peripheral circulation
- Severe arteriosclerosis, or active infection
- Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
- Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
- Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
- Cognition or communication impairments that prevent them from giving accurate and timely feedback.
- Cold allergy
- Cold agglutinin disorders like paroxysmal cold hemoglobinuria
- Buerger's disease
- Chilblains
- Cryoglobulinemia
- Sickle cell anemia
- Uncontrolled diabetes (physician discretion)
- Hypersensitivity to cold
- History of cold injury
- Severe cardiovascular disease, anesthetic skin, hypercoagulation disorders, poor circulation, extremities sensitive to pain, extremely low blood pressure that are incapacitated, decreased skin sensitivity, vein ligation...
The study team makes the final eligibility decision.
Where it's taking place
- New Orleans, Louisiana, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Orleans, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.