Cold and Compression Post TKA

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07023185
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ochsner Health System
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
Arms & Interventions

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

Device: - 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.

Other: - 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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ochsner Medical Center - Kenner, New Orleans, Louisiana

Status

Address

Ochsner Medical Center - Kenner

New Orleans, Louisiana, 70065

Site Contact

Vinod Dasa, MD

[email protected]

504-412-1705