Actively Recruiting
Cold and Compression Post TKA
Led by Ochsner Health System · Updated on 2026-04-02
90
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
O
Ochsner Health System
Lead Sponsor
B
BREG, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cold and Compression Post TKA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 years or older
- Patient scheduled for total knee arthroplasty at Ochsner Kenner
- Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation
- English speaking
- Diagnosed with primary osteoarthritis
You will not qualify if you...
- Chronic opioid use
- Opioid use within the last 3 months
- PCS score 30 or higher
- Diagnosis of inflammatory diseases like gout, rheumatoid arthritis, or lupus
- Discharge to skilled nursing facility
- Cold intolerance related to conditions such as Raynaud's
- Significant vascular problems in the affected limb
- Signs of inflammatory phlebitis, venous ulcers, or cellulitis
- Risk factors or signs of embolism such as pulmonary embolus or myocardial infarction
- Conditions where increased venous or lymphatic return is undesirable (e.g., lymphedema or cancer in the affected limb)
- Uncontrolled hypertension, cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency
- Unstable skin conditions like dermatitis, vein ligation, gangrene, or recent skin graft in the affected area
- Recent toe surgery in the affected limb
- Signs of peripheral edema such as deep vein thrombosis or chronic venous insufficiency
- Untreated acute fractures in the affected area
- Active local or systemic infections
- Conditions like diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, or rheumatoid arthritis
- Areas of damaged or broken skin that affect heat conduction
- Evidence of congestive heart failure
- Pre-existing deep vein thrombosis or pulmonary embolism
- Acute vein inflammation (thrombophlebitis)
- Arterial problems or erysipelas
- Cancer or cancer spread in the affected limb
- Severe high blood pressure or decompensated hypertonia
- Acute inflammatory skin diseases or infections
- Venous or arterial occlusive diseases
- Medical situations where increasing venous or lymphatic return is harmful
- Poor peripheral circulation or severe arteriosclerosis
- Blood disorders that increase clotting risk
- Inflamed tissues from recent injury or chronic inflammation flare-ups
- Reduced circulation or nerve problems in the affected limb due to surgery or diabetes
- Cognitive or communication issues that prevent accurate feedback
- Cold allergy or related disorders such as paroxysmal cold hemoglobinuria
- Buerger's disease, chilblains, cryoglobulinemia, sickle cell anemia
- Uncontrolled diabetes as judged by a physician
- Sensitivity or history of injury from cold
- Severe cardiovascular disease, low blood pressure causing incapacitation, decreased skin sensitivity, or recent vein ligation or skin grafts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ochsner Medical Center - Kenner
New Orleans, Louisiana, United States, 70065
Actively Recruiting
Research Team
V
Vinod Dasa, MD
CONTACT
K
Ken Bode
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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