Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
NCT04797897 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-03-25
Summary
This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.
Conditions
- Non-inflammatory Degenerative Joint Disease
- Osteoarthritis
- Avascular Necrosis
- Requires Correction of Functional Deformity
- Fracture, Knee
Interventions
- DEVICE
-
CORI
unicondylar knee arthroplasty (UKA) treated with CORI
- DEVICE
-
Conventional
unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
Sponsors & Collaborators
-
Smith & Nephew, Inc.
lead INDUSTRY
Principal Investigators
-
Patricia McCracken · Smith & Nephew, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-12
- Primary Completion
- 2023-09-29
- Completion
- 2024-02-16
- FDA Device
- Yes
Countries
- Australia
- Hong Kong
- New Zealand
Study Locations
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