| CTRI Number |
CTRI/2025/09/094425 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [surgical outcome ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of postoperative outcomes of total knee replacement in different plane alignments of knee joint |
|
Scientific Title of Study
|
Comparison of postoperative outcomes of total knee replacement in different coronal plane alignments of knee joint |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreenivas Nalhe |
| Designation |
arthroplasty fellow |
| Affiliation |
jawaharlal nehru medical collge |
| Address |
ground floor ,Department of orthopedics, jawaharlal nehru medical collge , datta meghe institute of higher education and research , sawangi wardha
ground floor ,Department of orthopedics, jawaharlal nehru medical collge , datta meghe institute of higher education and research , sawangi wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
8275735681 |
| Fax |
|
| Email |
shreenalhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sandeep Shrivastava |
| Designation |
professor |
| Affiliation |
jawaharlal nehru medical collge |
| Address |
ground floor ,Department of orthopedics, jawaharlal nehru medical collge , datta meghe institute of higher education and research , sawangi wardha
datta meghe institute of higher education and research sawangi wardha
MAHARASHTRA
442107
India |
| Phone |
9765404068 |
| Fax |
|
| Email |
drsandeepshrivastava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreenivas Nalhe |
| Designation |
arthroplasty fellow |
| Affiliation |
jawaharlal nehru medical collge |
| Address |
ground floor ,Department of orthopedics, jawaharlal nehru medical collge , datta meghe institute of higher education and research , sawangi wardha
ground floor ,Department of orthopedics, jawaharlal nehru medical collge , datta meghe institute of higher education and research , sawangi wardha
MAHARASHTRA
442107
India |
| Phone |
8275735681 |
| Fax |
|
| Email |
shreenalhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| datta meghe institute of higher education and research sawangi wardha ,442001 , maharashtra , india |
|
|
Primary Sponsor
|
| Name |
datta meghe institute of higher education and research |
| Address |
sawangi wardha |
| Type of Sponsor |
Private 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 Sandeep Shrivastava |
ground floor ,department of orthopedics , jawaharlal nehru medical college |
datta meghe institute of higher education and research , sawangi wardha , maharashtra ,India
Wardha
MAHARASHTRA |
9765404068
drsandeepshrivastava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCHINSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
total knee replacement by kinematic alignment technique |
compared with 2 different alignments method |
| Intervention |
total knee replacement by mechanical alignment technique |
total knee replacement by mechanical alignment technique will be done |
| Comparator Agent |
total knee replacemt by functional alignment technique |
compared with two different alignment techniques |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with end stage osteoarthritis of knee
primary unilateral TKR |
|
| ExclusionCriteria |
| Details |
revision surgeries , neuromuscular disorders , severe deformity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of radiological outcome of different alignment TKR techniques |
comparison of radiological outcome of different alignment TKR techniques postoperatively within a week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of intraoperative parmeters |
surgical time & blood loss during surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shreenalhe@gmail.com].
- For how long will this data be available start date provided 28-08-2025 and end date provided 28-01-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
a randomised controllled trial to compare mechanical alignment and kinematic alignment in total knee replacement for patients aged 50 - 80 years with advanced knee arthritis .forty patients ( 20 per group ) will undergo surgery with standardised protocols and rehabilitation .Outcomes assessd include oxford knee score , range of motion , pain relief complications and revision rates over 6 months .The goal is to determine which alignment offers better functional results and patient satisfaction providing evidence to guide surgical technique selection |