Evaluation of the effect of improved accuracy of femoral component rotation angle on clinical outcomes in total knee arthroplasty using ROSA Knee, a robotic surgical assistant: A prospective, randomized controlled study with or without the use of the Femoral Rotation Tool

Evaluation of the effect of improved accuracy of femoral component rotation angle on clinical outcomes in total knee arthroplasty using ROSA Knee, a robotic surgical assistant: A prospective, randomized controlled study with or without the use of the Femoral Rotation Tool - Femoral rotation angle in total knee arthroplasty using ROSA Knee, a robotic surgical assistant

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049164

Enrollment

160

Registered

2022-11-01

Start date

2022-11-01

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, Rheumatoid arthritis

Interventions

Clinical evaluation (postoperatively at 3 months, 6 months, and 1 year) and a subject questionnaire (6 months, 1 year) in the rotation group, in which the Femoral Rotation Tool was used. Clinical eval

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who were diagnosed as needing TKA due to disorders of the knee joint Patients who provided written consent voluntarily with sufficient understanding after being given a thorough explanation regarding participation in this study

Exclusion criteria

Exclusion criteria: Patients for whom the Persona TM tibial component and CR insert cannot be used (cases with large bone defects, poor ligament balance, or posterior cruciate ligament injury, and revision cases)

Design outcomes

Primary

Measure	Time frame
Clinical evaluation (postoperatively at 3 months, 6 months, and 1 year) and a subject questionnaire (6 months, 1 year) in the rotation group, in which the Femoral Rotation Tool was used, and in the 3-degree rotation group.	—

Countries

Japan

Contacts

Public ContactKazue Hayakawa

Fujita health university Orthopaedics

hkazue@fujita-hu.ac.jp0562932169

Outcome results

None listed

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