| CTRI Number |
CTRI/2025/07/090691 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative outcome of patients undergoing different methods of total knee replacement |
|
Scientific Title of Study
|
Anterior vs posterior referencing in total knee replacement |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debjit banerjee |
| Designation |
Junior resident |
| Affiliation |
Rajindra Hospital Patiala |
| Address |
Orthopedics department
Rajindra hospital patiala
Government medical college
Patiala
PUNJAB
147001
India |
| Phone |
8944807408 |
| Fax |
|
| Email |
debjitbanerjee216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amandeep singh bakshi |
| Designation |
Professor |
| Affiliation |
Rajindra Hospital Patiala |
| Address |
Unit 2 orthopedics department
Patiala
Punjab
147001
Patiala
PUNJAB
147001
India |
| Phone |
9915745003 |
| Fax |
|
| Email |
dramangomco@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amandeep singh bakshi |
| Designation |
Professor |
| Affiliation |
Rajindra Hospital Patiala |
| Address |
Unit 2 orthopedics
Patiala
Punjab
147001
Patiala
PUNJAB
147001
India |
| Phone |
9915745003 |
| Fax |
|
| Email |
dramangomco@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajindra hospital patiala
Sangrur road
Patiala
Pin 147001 |
|
|
Primary Sponsor
|
| Name |
Rajendra hospital patiala |
| Address |
Rajendra hospital patiala
Government medical college
Sangrur road
Patiala
Punjab
147001
India |
| Type of Sponsor |
Government medical college |
|
|
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 debjit Banerjee |
Rajindra hospital patiala orthopedic department |
Orthopedics department
Patiala
Sangrur road
Pin 147001
Patiala
PUNJAB |
8944807408
debjitbanerjee216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college |
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 |
Total knee replacement |
Postoperative outcome of Anterior referencing in total knee replacement for 1 year |
| Comparator Agent |
Total Knee Replacement |
Postoperative outcome of posterior referencing in total knee replacement for 1 year |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
More than 45yrs
Undergoing unilateral TKR
Willing for written consent
Having osteoarthritis knee grade 2 as per kellgren Lawrence classification |
|
| ExclusionCriteria |
| Details |
Less than 45yrs
Infected tkr
Cardiac complications
Acl injury or reconstruction |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative outcome of anterior and posterior referencing in total knee replacement are same with no as such significant differences |
July 2024 to july 2025
Approximately 1 yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To analyze the postoperative functional outcome of the patient undergoing total knee replacement using posterior vs anterior referencing on basis of various preoperative and postoperative assessment (knee society score, WOMAC scores,range of motion score) The study will be conducted randomly using double blinded process to recruit the participants Time period of the study is around 1 yr . Analysis will be performed as per intentions to treat basis . |