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Study on Verification of Utility and Safety of Improved Cooling Therapy Equipment after Knee Arthroplasty

Study on Verification of Utility and Safety of Improved Cooling Therapy Equipment after Knee Arthroplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052250141
Enrollment
60
Registered
2025-10-27
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis of the knee

Interventions

Randomize of postoperative cooling therapy

Sponsors

yasuda tadashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 to 90 at the time of registration who underwent unilateral total knee arthroplasty for osteoarthritis of the knee. Patients who received sufficient explanation regarding participation in this clinical study and provided their written consent of their own free will.

Exclusion criteria

Exclusion criteria: Patients undergoing total knee replacement surgery for conditions other than osteoarthritis of the knee. Those who fall under the contraindications and prohibitions specified in the CE4000 II icing system. In addition, those who are deemed unsuitable for participation in this study by the principal investigator or co-investigator.

Design outcomes

Primary

MeasureTime frame
Improvement in postoperative day 7 range of motion of the operated knee joint compared to preoperative range of motion

Secondary

MeasureTime frame
Knee flexion and extension angles on the operative side on postoperative day 7 Total amount of analgesics used on postoperative day 7 10m walking speed on postoperative day 7 Timed Up-and-Go test on postoperative day 7 Numerical rating scale (NRS) of operative side knee pain on postoperative days 2 and 7 Study equipment malfunctions Illnesses occurring between the date of surgery and postoperative day 7

Contacts

Public ContactUtako Shirono

Kobe City Medical Center General Hospital

ushirono@kcho.jp+81-78-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026