FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/035056 [Registered on: 22/07/2021] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study to investigate the use of REAL INTELLIGENCEâ„¢ CORIâ„¢ in Knee Replacement Surgeries 
Scientific Title of Study   Prospective Multicenter, Study to evaluate the Safety and Effectiveness of CORI Robotics System in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) procedures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CORI.2019.07  Protocol Number 
NCT04786119  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Narendra Vaidya 
Designation  Managing Director and Chief Joint Replacement Surgeon 
Affiliation  Lokmanya Hospital 
Address  Sector No 24 Tilak Road

Pune
MAHARASHTRA
411044
India 
Phone    
Fax    
Email  md@lokmanyahospitals.in  
 
Details of Contact Person
Public Query  
Name  Nidhi Nagar 
Designation  Associate Vice President – Academics, Research and Digital Strategy 
Affiliation  Lokmanya Hospital 
Address  Sector No 24 Tilak Road

Pune
MAHARASHTRA
411044
India 
Phone    
Fax    
Email  drnidhi@lokmanyahospitals.in  
 
Source of Monetary or Material Support  
Smith and Nephew, Inc. 1450 E. Brooks Road, Memphis, TN 38116, United States  
 
Primary Sponsor  
Name  Smith and Nephew Inc 
Address  1450 E. Brooks Road, Memphis, TN 38116, United States 
Type of Sponsor  Other [Medical Device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Germany
India
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Narendra Vaidya  Lokmanya Hospital  402/ A Gokhale Nagar Road off Senapati Bapat Marg, Vetal Baba Chowk, Pune, Maharashtra 411016 India
Pune
MAHARASHTRA 		 919762313824

md@lokmanyahospitals.in 
Narendra Vaidya   Lokmanya Hospital (Satellite site)  Lokmanya Hospital, Sector No. 24, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044, India
Pune
MAHARASHTRA 		 919762313824

md@lokmanyahospitals.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee of Lokmanya Medical Research Center  Approved 
Institutional Ethics Committee of Lokmanya Medical Research Center  Approved 
Institutional Ethics Committee of Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CORI Robotics  Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The subject’s treating clinician has decided that REAL INTELLIGENCEâ„¢ CORIâ„¢ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject’s unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment.
- Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B.
A. Subject requires a cemented UKA as a primary indication due to any of the following conditions:
1. Non-inflammatory degenerative joint disease, including osteoarthritis
2. Avascular necrosis
3. Requires correction of functional deformity
4. Requires treatment of fractures that were unmanageable using other techniques
B. Subject requires a cemented TKA as a primary indication due to any of the following condition:
1. Degenerative joint disease, including osteoarthritis
2. Rheumatoid arthritis
3. Avascular necrosis
4. Requires correction of functional deformity
5. Requires treatment of fractures that were unmanageable using other techniques
- Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
- Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
- Subject plans to be available through one (1) year postoperative follow-up.
- Routine radiographic assessment is possible.
- Subject able to follow instructions and deemed capable of completing all study questionnaires 
 
ExclusionCriteria 
Details  Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA or TKA (e.g. stems, augments, or custom
made devices).
- Subject has been diagnosed with post-traumatic arthritis
- Subject receives bilateral UKA or TKA
- Subject does not understand the language used in the Informed Consent Form.
- Subject does not meet the indication or is contraindicated for UKA or TKA according to specific Smith+Nephew knee system’s Instructions For Use (IFU).
- Subject has active infection or sepsis (treated or untreated).
- Subject is morbidly obese with a body mass index (BMI) greater than 40.
- Subject is pregnant or breast feeding at the time of surgery.
- Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
- Subject has a condition(s) that may interfere with the TKA or UKA survival or outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal
insufficiency or neuromuscular disease, or an active, local infection).
- Subject in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt
their ability or willingness to participate in the study including mental illness, mental retardation, drug or
alcohol abuse.
- Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the
index joint.
- Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155 Section 3.5. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-operative leg alignment
Description:
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. 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Component Alignment - UKA
Description: 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 in UKA subjects. 		 6 weeks 
Component Alignment - TKA
Description: 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 in TKA subjects 		 6 weeks 
Radiographic assessment - UKA
Description: Radiographic assessment on antero-posterior
(A/P) and lateral (L) views shall be performed
to identify the presence of radiolucent lines,
osteolysis & implant migration in UKA subjects 		 12 months 
Radiographic assessment - TKA
Description: Radiographic assessment on antero-posterior
(A/P) and lateral (L) views shall be performed
to identify the presence of radiolucent lines,
osteolysis & implant migration in TKA subjects 		 12 months 
2011 Knee Society Score (KSS) - UKA
Description: Derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in UKA subjects. 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), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome. 		 Pre-op, 6 week, 6 month and 12 months 
2011 Knee Society Score (KSS) - TKA
Description: Derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in TKA subjects. 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), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome. 		 Pre-op, 6 week, 6 month and 12 months 
Oxford Knee Score (OKS) - UKA
Description: To specifically assess the patients perspective of outcome following knee arthroplasty surgery in UKA 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. 		 Pre-op, 6 week, 6 month and 12 months 
Oxford Knee Score (OKS) - TKA
Description: To specifically assess the patients 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. 		 Pre-op, 6 week, 6 month and 12 months 
Forgotten Joint Score (FJS) - UKA
Description: Joint-specific patient reported outcome in UKA subjects. Responses to 12 questions are recorded with a 5 point Likert format: Never, almost never, seldom, sometimes and mostly.
The scores are summed & linearly transformed in a 0 to 100 scale and reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during activities of daily living. A score of 100 is the best possible outcome. 		 6 week, 6 month and 12 months 
Forgotten Joint Score (FJS) - TKA
Description: Joint-specific patient reported outcome in TKA subjects. Responses to 12 questions are recorded with a 5 point Likert format: Never, almost never, seldom, sometimes and mostly.
The scores are summed & linearly transformed in a 0 to 100 scale and reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during activities of daily living. A score of 100 is the best possible outcome. 		 6 week, 6 month and 12 months 
Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores - UKA
Description: EQ-5D-5L is composed of the descriptive system & EQ Visual Analogue scale (EQ VAS). The descriptive system has 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each has 5 levels: no problems, slight, moderate, severe, & extreme problems. The EQ VAS ranges from the best health you can imagine to the worst health you can imagine. A higher number is a better outcome. 		 Pre-op, 6 week, 6 month and 12 months 
Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores - TKA
Description: EQ-5D-5L is composed of the descriptive system & EQ Visual Analogue scale (EQ VAS). The descriptive system has 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each has 5 levels: no problems, slight, moderate, severe, & extreme problems. The EQ VAS ranges from the best health you can imagine to the worst health you can imagine. A higher number is a better outcome. 		 Pre-op, 6 week, 6 month and 12 months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="7" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2021 
Date of Study Completion (India) 06/03/2024 
Date of First Enrollment (Global)  17/02/2021 
Date of Study Completion (Global) 10/09/2024 
Estimated Duration of Trial   Years="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications.

Objectives:
The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving postoperative leg alignment to check that the results of the operation are similar to what the surgeon originally planned.

Research participants / locations:
140 research participants will be recruited from up to 6 sites in 4 countries globally (UK, US, Germany and India). There will be 70 patients having UKA surgery and 70 patients having TKA surgery.
 
Close