| CTRI Number |
CTRI/2026/01/102040 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Knee Phenotyping Prior To Total Knee Arthroplasty : Can We Eliminate The Need of Long Leg Radiographs With An Imageless Robotic System? |
|
Scientific Title of Study
|
Knee Phenotyping Prior To Total Knee Arthroplasty : Can We Eliminate The Need of Long Leg Radiographs With An Imageless Robotic System? |
| Trial Acronym |
RATKA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adit Maniar |
| Designation |
Consultant Orthopaedic Surgeon |
| Affiliation |
Lilavati Hospital and Research Centre |
| Address |
Department of Orthopaedics,
A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 Department of Orthopaedics,
A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 Mumbai MAHARASHTRA 400054 India |
| Phone |
9920010666 |
| Fax |
|
| Email |
aditmaniar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Adit Maniar |
| Designation |
Consultant Orthopaedic Surgeon |
| Affiliation |
Lilavati Hospital and Research Centre |
| Address |
A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 Mumbai MAHARASHTRA 400054 India |
| Phone |
9920010666 |
| Fax |
|
| Email |
aditmaniar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Adit Maniar |
| Designation |
Consultant Orthopaedic Surgeon |
| Affiliation |
Lilavati Hospital and Research Centre |
| Address |
A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 Mumbai MAHARASHTRA 400054 India |
| Phone |
9920010666 |
| Fax |
|
| Email |
aditmaniar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lilavati Hospital and Research Centre,
Department of Orthopaedics,
A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra, 400050, India |
|
|
Primary Sponsor
|
| Name |
Dr. Adit Maniar |
| Address |
Dr. Maniars Clinic, 2nd Floor, S.V. Road, Santacruz (West), Mumbai-400054. |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adit Maniar |
Lilavati Hospital & Research Centre |
Department of Orthopaedics, A-791 Bandra Reclamation Road, Bandra West, Mumbai - 400050, Maharashtra, India Mumbai (Suburban) MAHARASHTRA |
9920010666
aditmaniar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LILAVATI HOSPITAL AND RESEARCH CENTRE, ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
i. Undergoing Primary unilateral or bilateral Robotic assisteted total knee arthroplasty
ii. Able to stand without support preoperatively
iii. Agreeing to participate in the study
|
|
| ExclusionCriteria |
| Details |
i. Undergoing revision or unicompartmental knee arthroplasty
ii. Previous injury to lower limb leading to an extra articular deformity
iii. Unable to stand without support preoperatively
iv. Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the correlation between hip-knee-ankel angle, mechanical medial proximal tibial angle and mechanical lateral distal femoral angle measured by
a) preoperative long leg radiographs
b) intraoperative positioning of implants
c) postoperative processing of data by engineers using exact measured cartilage thickness.
|
Preoperative, Intraoperative and postoperative processing of data between 1-2 weeks after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
22/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
a) Background: Robot Assisted Total Knee Arthroplasty (RA TKA) has been shown to have increased accuracy and precision [1,2]. In recent years we have better understood the importance of knee phenotypes based on bony morphology on the outcomes of TKA [3-5]. There are multiple different systems used to classify these knee phenotypes [6,7]. All of them use three main angle measurements: hip-knee-ankle angle (HKA), mechanical medial proximal tibial angle (mMPTA) and mechanical lateral distal femoral angle (mLDFA). To measure these parameters, we need a standing long leg radiograph. However, this involves increased radiation exposure and can be time consuming. b) Lacunae / Justification : Currently, there is no alternative to long leg radiographs for the measurement of these three angles. We have developed a way to measure these parameters intraoperatively and postoperative processing of the data by the engineering team. So far there is no study validating the use of this technique to measure these angles. By validating our technique, our aim is to eliminate the need of preoperative long leg radiographs to measure these parameters. |