Effect of Different Cold Therapy Programs in Patients Received Total Knee Arthroplasty Operation

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ID
NCT07021287
Status
Recruiting
Apply to this trial

Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • mixed ice and water, continuous ice application — OTHER
    the ice pack was placed on the knee joint immediately after returning to the ward for 24 hours, and the ice pack was replaced every 3 to 4 hours, if it melted, replaced immediately.
  • mixed ice and water, intermittent ice compress — OTHER
    within 72 hours after operation, the patients were given ice compress for 20 minutes each time, with an interval of 2 hours, 3 times a day
  • full ice, continuous ice compress — OTHER
    After returning to the ward, an ice pack should be placed on the knee for 24 hours. The ice pack should be replaced every 3-4 hours and replaced immediately if melted
  • full ice, intermittent ice compress — OTHER
    Within 72h after surgery, the patient applied ice for 20min each time, with an interval of 2h,3 times a day.

Study Details

This study conducts clinical experiments on the form, temperature, frequency and other issues of cooling therapy, so as to provide scientific evidence for the practice of cooling therapy and improve the comfort and effect of cooling therapy, so as to achieve the goal of improving service and patient experience proposed by the National Health Commission.

Key Dates

First listed
Jun 13, 2025
Start date
Jul 6, 2024
Status verified
Jun 2025
Primary completion
Apr 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: mixed ice and water, continuous ice application
    after returning to the ward, the ice pack was placed on the knee joint for 24 hours, and the ice pack was replaced every 3 to 4 hours, if it melted, replaced immediately.
  • Experimental: mixed ice and water, intermittent ice compress
    within 72 hours after operation, the ice compress time was 30 minutes each time, the interval time was 2 hours, 3 times a day
  • Experimental: full ice, continuous ice compress
    after returning to the ward, the ice pack was placed on the knee joint for 24 hours, and the ice pack was replaced every 3 to 4 hours, if it melted, replaced immediately
  • Experimental: full ice, intermittent ice compress
    within 72 hours after operation, the patients were given ice compress for 20 minutes each time, with an interval of 2 hours, 3 times a day.

Primary Outcome Measure

numerical rating scale ，NRS [ Time Frame: Day 1, Day2, Day 3 ]

Central Contacts

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