NCT04797897

Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.

Detailed description

This is a prospective, multi-center, randomized study to demonstrate the safety and effectiveness of CORI. In addition, the study will support regulatory approval by the National Medical Products Administration (NMPA) in China. The study will have two arms, the investigational group will be total knee arthroplasty (TKA) using CORI, the comparison group will be conventional approach with conventional manual instrumentation.

Conditions

• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis
• Avascular Necrosis
• Requires Correction of Functional Deformity
• Fracture, Knee

Interventions

Type	Name	Description
DEVICE	CORI	unicondylar knee arthroplasty (UKA) treated with CORI
DEVICE	Conventional	unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation

Timeline

• Start date: 2022-02-12
• Primary completion: 2023-09-29
• Completion: 2024-02-16
• First posted: 2021-03-15
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

3 sites across 3 countries: Australia, Hong Kong, New Zealand

Regulatory

• FDA-regulated device study