Cold and Compression Post TKA

NCT07023185 | Recruiting FDA Device

• 1 other identifier: 2025.069
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

total knee replacement; primary osteoarthritis

Outcome Measures

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

  Enrollment to 6 months post-surgery

Study Arms (2)

Standard of Care Arm

ACTIVE COMPARATOR

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)

Cold and Compression

EXPERIMENTAL

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

Cold and Compression DEVICE

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.

Cold and Compression

SOC (Standard of care) OTHER

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)

Standard of Care Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 yr or older
• Patient of Dr. Howard Hirsch or Dr. Vinod Dasa scheduled for total knee arthroplasty (knee replacement) at Ochsner Kenner
• Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
• English speaking
• Diagnosis of primary osteoarthritis

You may not qualify if:

• Chronic opioid use
• Opioid use within the last 3 months
• PCS score ≥ 30
• Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
• Discharge to skilled nursing
• Cold intolerance related to diseases, like Raynaud's
• Significant vascular impairment in the affected region
• Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
• 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)
• 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).
• Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
• Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
• Had recent toe surgery in the affected region
• 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).
• An acute, unstable (untreated) fracture in the affected region.

Sponsors & Collaborators

• Ochsner Health System: lead
• BREG, Inc: collaborator

Study Sites (1)

Ochsner Medical Center - Kenner

New Orleans, Louisiana, 70065, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Vinod Dasa, MD

CONTACT

(504) 412-1705; vdasa@lsuhsc.edu

Ken Bode

CONTACT

504-842-1936; ken.bode@ochsner.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (1)