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NCT04848896: CORI RCT TKA
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
NA trial testing CORI Robotics in Arthroplasty in 140 participants. Currently enrolling.
17 April 2026
Quick facts
| Lead sponsor | Smith & Nephew, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 12 February 2022 |
| Primary completion | 17 April 2026 |
| Estimated completion | 31 March 2028 |
| Sites | 4 locations across China, Hong Kong, New Zealand, Australia |
Drugs / interventions tested
- CORI Robotics
- Conventional Procedure
Conditions studied
- Arthroplasty — all drugs for Arthroplasty →
- Replacement — all drugs for Replacement →
- Knee — all drugs for Knee →
Sponsor
Smith & Nephew, Inc. — full company profile →
Who can join
18 and older, any sex, with Arthroplasty or Replacement. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04848896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CORI Robotics
Trials testing the same drug.
- NCT04786119 — Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures · NA · completed
Other recruiting trials for Arthroplasty
Currently open trials in the same condition.
- NCT07425457 — Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial) · NA · recruiting
- NCT06323980 — INHANCE Stemless Reverse Shoulder IDE · NA · recruiting
- NCT04849884 — To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. · NA · active not recruiting
- NCT05190666 — Healthy Living After Knee Replacement · NA · active not recruiting
Other Smith & Nephew, Inc. trials
Trials by the same sponsor.
- NCT07025304 — Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate · NA · recruiting
- NCT06916728 — A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Ca · enrolling by invitation
- NCT06831448 — Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin. · NA · completed
- NCT06700850 — Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin · NA · completed
- NCT06306716 — A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04848896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
- Last refreshed: 11 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04848896.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing