Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
Conditions
Keywords
total knee replacement, primary osteoarthritis
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.
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.
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)
Sponsors
Ochsner Health System
BREG, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain NRS subscale | Enrollment to 6 months post-surgery | Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups |
Countries
United States
Contacts
CONTACTVinod Dasa, MD
CONTACTKen Bode
Outcome results
None listed