Trials / Recruiting
RecruitingNCT07023185
Cold and Compression Post TKA
Cold and Compression After Total Knee Arthroplasty for Pain Attenuation: A Randomized, Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Ochsner Health System · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2027-06-01
- Completion
- 2028-06-01
- First posted
- 2025-06-15
- Last updated
- 2026-04-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07023185. Inclusion in this directory is not an endorsement.