| CTRI Number |
CTRI/2026/02/104353 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ACCUBALANCE GRAPH
ANALYSIS IN VIEW OF DIFFERENCES BETWEEN SURGEONS IN NON CT BASED ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY: A
PROSPECTIVE OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
INTER AND INTRA-OBSERVER RELIABILITY OF ACCUBALANCE GRAPH
ASSESSMENT IN IMAGELESS ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY: A
PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Udhayaprakash Saminathan |
| Designation |
Fellow in arthroplasty |
| Affiliation |
Ganga hospital |
| Address |
Arthroplasty department, B block, Ganga hospital, 313, mettupalayam road
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7708057304 |
| Fax |
|
| Email |
udhayaprakashthesis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Udhayaprakash Saminathan |
| Designation |
Fellow in arthroplasty |
| Affiliation |
Ganga hospital |
| Address |
Arthroplasty department, B block, Ganga hospital, 313,Mettuplayam road
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7708057304 |
| Fax |
|
| Email |
udhayaprakashthesis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Udhayaprakash Saminathan |
| Designation |
Fellow in arthroplasty |
| Affiliation |
Ganga hospital |
| Address |
Arthroplasty department , B block, Ganga hospital, 313, mettuplayam road
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7708057304 |
| Fax |
|
| Email |
udhayaprakashthesis@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ganga hospital |
| Address |
313,Mettuplayam road , coimbatore.641043 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 S Rajasekhar |
Ganga hospital |
operation theatre, arthroplasty department
Coimbatore
TAMIL NADU |
9843022325
rajasekaran.ortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
primary TKA for osteoarthritis , complete accubalance graph data captured intraoperatively, preoperative deformity less than 20 degrees |
|
| ExclusionCriteria |
| Details |
revision total knee replacement , inflammatory arthritis , post traumatic arthritis, severe bone loss requiring augmentation, severe extra articular deformity , incomplete or technically inadequate accubalance recordings |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the inter and intraobserver reliability of accubalance graph interpretation in VELYS robotic assisted TKA |
Intraoperatively recorded at the completion of gap assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess agreement on specific parameters: medial/lateral
gap measurements, varus-valgus alignment throughout flexion arc.
- To identify which accubalance parameters demonstrate the
highest & lowest reliability.
- To evaluate if the surgeon’s experience level affects
interpretation reliability
- To determine if certain knee pathologies ( varus vs valgus
deformity) affect interpretation consistency |
Intraoperatively assessed immediately after completion of gap assessment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Robotic-assisted total knee arthroplasty has emerged as a technology to enhance surgical precision and soft tissue balancing.
Imageless robotic-assisted total knee arthroplasty has enabled objective, real-time assessment of knee balance throughout the range of motion
These systems provide quantitative intra-operative feedback through graphical representations of medial and lateral compartment gaps, commonly displayed as balance graphs
While the accuracy of these robotic systems is noted, the reliability of balance graph interpretation by different observers and by the same observer over time remains underexplored.
This prospective observational study aims to assess the inter-observer and intra-observer reliability of AccuBalance graph assessment in imageless robotic-assisted TKA, without disrupting standard surgical workflows.
The study’s findings will support the validation of robotic balance assessment tools for clinical use and research applications. |