Cold and compression after total knee replacement
Cold and Compression After Total Knee Arthroplasty for Pain Attenuation: A Randomized, Controlled Trial
This tests whether using a cold-compression device after total knee replacement reduces pain compared with standard care for adults with primary osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Ochsner Health System Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT07023185 on ClinicalTrials.gov |
What this trial studies
Adults aged 50 and older scheduled for total knee arthroplasty at Ochsner Kenner will be assigned to receive a cold/compression device plus usual care or to receive usual care alone. Pain will be measured using the PROMIS NRS Pain Subscale before surgery, daily for the first 14 days after surgery, weekly for three months, and again at six months. Key exclusions include chronic or recent opioid use, inflammatory arthritides, significant vascular disease, cold intolerance, and discharge to skilled nursing. The intervention is delivered postoperatively alongside outpatient physical therapy at OTW Driftwood and outcomes focus on patient-reported pain over time.
Who should consider this trial
Good fit: Adults 50 years or older with primary osteoarthritis scheduled for total knee arthroplasty at Ochsner Kenner who plan to receive outpatient physical therapy at OTW Driftwood, speak English, and are not recent or chronic opioid users.
Not a fit: Patients with inflammatory arthritis, significant vascular impairment or active local infection, cold intolerance (e.g., Raynaud's), chronic or recent opioid use, or those discharged to skilled nursing are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative pain and swelling after total knee replacement and may decrease reliance on opioids during recovery.
How similar studies have performed: Previous studies of postoperative cold therapy and compression devices have reported modest reductions in pain and swelling, but results have been variable across trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Orleans, Louisiana
- Ochsner Medical Center - Kenner — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Vinod Dasa, MD
- Email: vdasa@lsuhsc.edu
- Phone: (504) 412-1705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.