Recruiting

Cold/Compression

Sponsor:

Ochsner Health System

Code:

NCT07023185

Conditions

Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Cold and Compression

SOC (Standard of care)

Study Details

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.

Conditions

Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Study ID

NCT07023185

Start date

Dec 15, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Arm

Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)

experimental: Cold and Compression

Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor)

Interventions

Cold and Compression

External mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone.

SOC (Standard of care)

Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)

Primary outcome measure

  • PROMIS Pain NRS subscale [ Time Frame: Enrollment to 6 months post-surgery ]

Central Contacts and Locations

Locations

Ochsner Medical Center - Kenner

Recruiting

New Orleans, Louisiana, United States, 70065

Contacts

Nicole Villemarette-Pittman, PhD

nicole.villemarettepittman@ochsner.org

Principal Investigator:

Vinod Dasa, MD

More Information

Sponsor

Ochsner Health System

Last update posted

Apr 2, 2026

Last verified

Apr, 2026

Keywords

  • total knee replacement
  • primary osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2026-04-02.