Clinical trial NCT07023185: Cold and Compression Post TKA
Official title: Cold and Compression After Total Knee Arthroplasty for Pain Attenuation: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
Keywords: total knee replacement
primary osteoarthritis
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: BREG, Inc
First posted: 2025-06-15
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 50 yr or older
2. Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner
3. Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
4. English speaking
5. Diagnosis of primary osteoarthritis

Exclusion Criteria:

1. Chronic opioid use
2. Opioid use within the last 3 months
3. PCS score ≥ 30
4. Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
5. Discharge to skilled nursing
6. Cold intolerance related to diseases, like Raynaud's
7. Significant vascular impairment in the affected region
8. Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
9. 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)
10. 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).
11. Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
12. Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
13. Had recent toe surgery in the affected region
14. 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 failure, cirrhosis/liver failure, renal failure).
15. An acute, unstable (untreated) fracture in the affected region.
16. Any active local or systemic infection.
17. Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
18. 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 Care Wave System.
19. Presumptive evidence of congestive heart failure
20. Pre-existing DVT condition
21. Deep acute venal thrombosis (Phlebothrombosis)
22. Episodes of pulmonary embolism
23. Pulmonary edema
24. Acute inflammation of the veins (Thrombophlebitis)
25. Decompensated cardiac insufficiency
26. Arterial dysregulation
27. Erysipelas
28. Carcinoma and carcinoma metastasis in the affected extremity
29. Decompensated hypertonia
30. Acute inflammatory skin diseases or infection
31. Venous or arterial occlusive disease
32. Medical situations where increased venous or lymphatic return is undesirable
33. Poor peripheral circulation
34. Severe arteriosclerosis, or active infection
35. Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
36. Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
37. Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
38. Cognition or communication impairments that prevent them from giving accurate and timely feedback.
39. Cold allergy
40. Cold agglutinin disorders like paroxysmal cold hemoglobinuria
41. Buerger's disease
42. Chilblains
43. Cryoglobulinemia
44. Sickle cell anemia
45. Uncontrolled diabetes (physician discretion)
46. Hypersensitivity to cold
47. History of cold injury
48. 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 or recent skin grafts, or pheochromocytoma.

Primary outcomes:
measure: PROMIS Pain NRS subscale
timeFrame: Enrollment to 6 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center - Kenner
state: Louisiana
Study officials:
References: