An interventional study of CORI Robotics and Conventional Procedure in Arthroplasty, Replacement and Knee, sponsored by Smith & Nephew, Inc.. Active, not recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Smith & Nephew, Inc. · Not applicable, Interventional, and Treatment
Among 33 studies in Osteoarthritis by Smith & Nephew, Inc. — 2 open to participants now, 7 under way, none of them phase 3. Osteoarthritis · Smith & Nephew, Inc..
Among the 33 studies in Osteoarthritis by Smith & Nephew, Inc., this one is the 4th largest by planned enrollment of the 12 interventional ones, is one of 4 that started in 2022, is one of 12 with no phase, and was the 29th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →2 of the 33 studies in Osteoarthritis by Smith & Nephew, Inc. are open now, in 1 country. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →33 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2022.
Median enrollment 88 across the 12 interventional studies, 131 across the 21 observational. Of the 24 that completed or were terminated, 10 (42%) have results posted.
Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
1 of the studies in Osteoarthritis by Smith & Nephew, Inc. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06319911Smith & Nephew, Inc.AETOS Shoulder System | 2027-08-30 |
Among the 33 studies in Osteoarthritis by Smith & Nephew, Inc., from their registry updates:
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:
80 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 roughly 40 patients having TKA using CORI and 40 patients having TKA using conventional procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject requires a cemented TKA as a primary indication that meets any of the following condition:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with CORI Robotics System.
Device: CORI Robotics
Subjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Procedure: Conventional Procedure
Total knee arthroplasty (TKA) treated with CORI Robotics System.
Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.
Post-operative Leg Alignment
Post-operative leg alignment via radiographic assessment. Post-operative leg alignment is achieved when the deviation from the subject specific target does not exceed ±3 degrees.
Time frame: 6 weeks
Component Alignment
Component alignment will be assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery
Time frame: 6 weeks
Radiographic Assessment
Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis \& implant migration.
Time frame: 12 months and 24 months
2011 Knee Society Score (KSS)
The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in TKA subjects. The 2011 Knee Society Score consists of 4 separate subscales: 1. An "Objective" Knee Score (seven items: 100 points) 2. A Patient Satisfaction Score (five items: 40 points) 3. A Patient Expectation Score (three items: 15 points) 4. A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Oxford Knee Score (OKS)
To specifically assess the patient's perspective of outcome following knee arthroplasty surgery in TKA subjects. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Forgotten Joint Score (FJS)
To assess joint-specific patient reported outcomes in TKA subjects. Responses to 12 questions are recorded with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome.
Time frame: 6 weeks, 6 months, 12 months and 24 months
EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
To assess the subject's health state in TKA subjects. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome.
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Jun 2026, 51 months.
Of 135 industry-sponsored interventional studies with no phase under Osteoarthritis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 81. This study's 51 months is above that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Apr 2026 → Jun 2026 and completion Mar 2028 → Jul 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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