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CTRI Number  CTRI/2024/03/063826 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 6 month trial in Partial Knee Replacement vs Total Knee Replacement in elderly more than equal to 70 years of age 
Scientific Title of Study   A Comparison of 6 month Post operative Patient Reported Outcome and Adverse Events after Unicompartmental Knee Arthroplasty vs Total Knee Arthroplasty in elderly patients with age more than equal to 70 years : A Randomised Controlled Trial 
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 Aryan Mechu 
Designation  Junior Resident 
Affiliation  AIIMS JODHPUR 
Address  Room no. 52, Ground Floor C Block, OPD, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9462716534  
Fax    
Email  aryanmechu1512@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saurabh Gupta 
Designation  Assistant professor 
Affiliation  AIIMS JODHPUR 
Address  Room No. 52, Ground Floor C Block, OPD Block, Orthopaedics Department, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7023578365  
Fax    
Email  dr.saurabhortho@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay Elhence 
Designation  Professor and Head 
Affiliation  AIIMS JODHPUR 
Address  Room no. 55, Ground Floor C Block, OPD , Orthopaedics Department, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996926  
Fax    
Email  abhayelhence@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur Research Cell 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  Marudhara Industrial Area, 2nd phase, MIA 1st phase, Basni, 342005, Jodhpur, Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aryan Mechu   AIIMS Jodhpur  3rd floor, B block, IPD block,Orthopaedics Department, AIIMS Jodhpur, 342005
Jodhpur
RAJASTHAN 		 9462716534

aryanmechu1512@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutuional Ethics Committee, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Total knee Arthroplasty   Total knee Arthroplasty done as per standardised protocol. Inclusion and exclusion criteria will be followed as per protocol. 
Intervention  Unicompartmental Knee Arthroplasty  Unicompartmental knee Arthroplasty done as per standardised protocol. inclusion and exclusion criteria will be followed as per protocol. 
 
Inclusion Criteria  
Age From  70.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  More than equal to 70 years old patients
Antero Medial compartment varus osteoarthritis of knee
Flexion more than 90 degrees
Flexion contracture less than 10 degrees
Varus deformity less than 20 degrees
 
 
ExclusionCriteria 
Details  Grade II-IV degenerative changes of lateral compartment
H/O Lateral meniscectomy
Anterior cruciate ligament absence
BMI more than 40 Kg/m2
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional Outcome:
a) 2 minute walk test
b) KOOS score
c) KSS 2011 score
d) FJS (Forgotten joint score)
 		 Functional Outcome:
a) Baseline
b)1 week
c)12 week
d) 24 week
 
 
Secondary Outcome  
Outcome  TimePoints 

To determine implant positioning between both groups
To determine survivorship with Kaplan Meier chart (Resurgery)
To see post op adverse events
 		 3 months follow up
 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 4 
Date of First Enrollment (India)   20/03/2024 
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 Applicable 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Nil).

  6. For how long will this data be available start date provided 22-01-2024 and end date provided 25-01-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The aim of this study is to compare 6-month postoperative patient reported outcome measures (PROM) and post operative adverse events (POAE) after unicompartmental knee arthroplasty(UKA) versus total knee arthroplasty(TKA) in age more than equal to 70 years.


OBJECTIVES:


  1. PRIMARY OBJECTIVE: 


  • To compare 6-month PROM and POAE in patients undergoing UKA versus TKA





  1. SECONDARY OBJECTIVE:



  1. To determine implant positioning between both groups

  2. To determine survivorship with Kaplan Meier chart (Resurgery)





                                 MATERIALS AND METHODS:


This will be randomized controlled trial. The study will be executed in the department of Orthopedics at All India Institute of Medical Science, Jodhpur for a period of 2 years.

STUDY DESIGN: A double blinded non inferiority randomized controlled trial 


SAMPLING SIZE: 



Where           is standard deviation

Zα2 is the standard normal z-value for a significance level α = 0.05, which is 1.196. 

Zβ is the standard normal z-value for the power of 80%, which is 0.84.

μ1-μ2 –is the difference in mean values of the 2 groups



The sample size calculated according to above formula using study by Boonchana et.al was 60 (30 in each group).

NULL HYPOTHESIS – There is similar PROM and POAE between UKA and TKA.

ALTERNATE HYPOTHESIS- There is dissimilar PROM and POAE between UKA and TKA

 
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