NCT05966519

ROSA Knee Intraoperative Planning Flexibility Study

ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.

Detailed description

The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique. The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan \& intra-op final plan. The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.

Conditions

• Osteo Arthritis Knee
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Total Knee Replacement (TKR)	Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses

Timeline

• Start date: 2024-01-05
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2023-07-28
• Last updated: 2026-04-08

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study