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RecruitingNCT07023185Updated Apr 2, 2026

Cold and Compression Post TKA

An interventional study of Cold and Compression and SOC (Standard of care) in Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, sponsored by Ochsner Health System. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Ochsner Health System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Keywords

  • total knee replacement
  • primary osteoarthritis
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study 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)

    Other: SOC (Standard of care)

  • 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)

    Device: Cold and Compression

Interventions

  • DeviceCold 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.

  • OtherSOC (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)

05

What researchers measure

Primary outcomes

  1. PROMIS Pain NRS subscale

    Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups

    Time frame: Enrollment to 6 months post-surgery

06

Study locations

1 of 1 sites recruiting
  • Ochsner Medical Center - Kenner
    New Orleans, Louisiana 70065, United States
    • Vinod Dasa, MD · Contact · vdasa@lsuhsc.edu · 504-412-1705
    • Nicole Villemarette-Pittman, PhD · Contact · nicole.villemarettepittman@ochsner.org
    • Vinod Dasa, MD · Principal investigator
    • Howard Hirsch, MD · Sub investigator
    • Nicole Villemarette-Pittman, PhD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07023185
Lead sponsor
Ochsner Health System
Collaborators
BREG, Inc
Responsible party
Sponsor
First posted
Jun 15, 2025
Start date
Dec 15, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Apr 2, 2026

Study contacts

Vinod Dasa, MD
Contact
vdasa@lsuhsc.edu
(504) 412-1705
Ken Bode
Contact
ken.bode@ochsner.org
504-842-1936

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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