| CTRI Number |
CTRI/2026/03/106207 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
TO STUDY HOW ROTATION OF COMPONENTS ADVERSELY AFFECTS THE OUTCOME AFTER TOTAL KNEE ARTHROPLASTY |
|
Scientific Title of Study
|
EFFECT OF COMPONENT ROTATIONAL ALIGNMENT ON FEMORO-TIBIAL ROTATIONAL ALIGNMENT IN TOTAL KNEE ARTHROPLASTY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alan Ajayan Philip |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JNMC WARDHA, SAWANGHI(MEGHE) |
| Address |
Department of Orthopaedics, Acharya Vinoba Bhave Rural Hospital, JNMC Wardha, Sawanghi(Meghe)- 442107
Wardha
MAHARASHTRA
442107
India |
| Phone |
9372042347 |
| Fax |
|
| Email |
philipalan14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor |
| Affiliation |
JNMC WARDHA, SAWANGHI(MEGHE) |
| Address |
Department of Orthopaedics, Acharya Vinoba Bhave Rural Hospital, JNMC Wardha, Sawanghi(Meghe)- 442107
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alan Ajayan Philip |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JNMC WARDHA, SAWANGHI(MEGHE) |
| Address |
Department of Orthopaedics, Acharya Vinoba Bhave Rural Hospital, JNMC Wardha, Sawanghi(Meghe)- 442107
Wardha
MAHARASHTRA
442107
India |
| Phone |
9372042347 |
| Fax |
|
| Email |
philipalan14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ALAN AJAYAN PHILIP |
| Address |
S10, RAGHOBAJI BOYS PG HOSTEL, JNMC WARDHA, SAWANGHI(MEGHE)- 442107 |
| Type of Sponsor |
Other [Self] |
|
|
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 Alan Ajayan Philip |
ACHARYA VINOBHA BHAVE RURAL HOSPITAL |
Ward no 34, 35 and 36, Department of Orthopaedics, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, Maharashtra 442107
Wardha
MAHARASHTRA |
9372042347
philipalan14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Patients willing to undergo Total knee arthroplasty
-Patients between the ages of 40-80 years of age |
|
| ExclusionCriteria |
| Details |
-Patients with pre-existing hip and ankle deformities
-Patients with previous knee surgery over the same limb
-Patients with inflamatory arthropathies or pathological conditions that may obscure measuring lanmarks
-Post operative complications that may affect rotational measurement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate whether component malalignement and mismatch affects the axial rotation motion during passive knee flexion after total knee arthroplasty
|
Pre-operatively, Post-operative baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate patient satisfaction & risk of failure of impact using Functional Outcome Scores |
Pre-operatively, Post-operative baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
31/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Rotational Alignemnt is goof dor functional outcome and long term success of Total Knee Arthroplasty. Malalignment causes- 1)Patellofemoral complications such s Subluxation, Dislocation, Wear and tear. 2)Abnormal internal and external alignment can cause instability, implant loosening and unexplained painful total knee arthroplasty.. Achieving correct femoro-tibial rotation is difficult with both conventional and navigation systems. Alignment errors after TKA has led to rigorous evaluation of surgical techniques. Alignment in trnasverse plane is problematic due to- 1)Errors of component malalignemnt relative to bone anatomical landmark 2)Mismatch between femoral and tibial components relative position. Both resulting in small rotational errors.
This prospective study evaluates whether component malalignement and mismatch affects the axial rotation motion during passive knee flexion after total knee arthroplasty
This is a prospective study is on the patients that are admitted in Acharya Vinoba Bhave Rural Hospital, Sawanghi(Meghe) that are willing to undergo Total Knee Arthroplasty between June 2025 and December 2027.
Consecutive sampling method will be used. A total sample size of 45 knees will be taken into account using formula developed by William G. Cochran
Postoperative assessment of rotational alignment will be evaluated using CT scan. Femoral component alignment relative to Surgical Transepicondylar axis. Tibial component alignment relative to Akagi’s line.
Postoperative femorotibial rotation on passive flexion of knee will be assessed using Xray Radiography
Functional outcome scores using KSS score, WOMAC score will be done to assess pain and limitations following TKA
Bases on the results of CT scan the participants will be categorised into nominal group(Femoral component rotation <3, Tibial component rotation <10, Femorotibial rotation <5) and Outlier group(Femoral component rotation >3, Tibial component rotation >10, Femorotibial rotation >5)
Statistical Analysis will be done using Descriptive statistics Test for normalcy using Shapiro Wilk Test, Histogram, Q-Q plots Inferential statistics using Independent t-test/Mann Whitney U test, One way ANOVA, Chi-Square test, Pearson/Spearman correlation coefficient
A p-value <0.005 will be considered significant
This study seeks to improve functional outcomes, patient satisfaction, implant longevity in total knee arthroplasty by addressing one of its most common yet underevaluated causes of failure; rotational malalignment |