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
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.
Exclusion Criteria:
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)
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
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)
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
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.
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