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CTRI Number  CTRI/2026/01/101136 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Patient Outcomes and Adverse Events in Mobile vs. Fixed Bearing Unicompartmental Knee Arthroplasty: A Randomized Controlled Trial 
Scientific Title of Study   Comparison of post operative patient reported outcomes and adverse events in mobile bearing versus fixed bearing unicompartmental knee arthroplasty: Randomized 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  Ritvik Sharma 
Designation  Junior resident 
Affiliation  All India Institute Of Medical Sciences, Jodhpur 
Address  Department of orthopaedics, OPD C block, AIIMS Jodhpur
Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  07009892538  
Fax    
Email  ritz.ptk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saurabh Gupta 
Designation  Associate professor 
Affiliation  All India Institute Of Medical Sciences, Jodhpur 
Address  Dept. of Orthopaedics, AIIMS Jodhpur
Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  7023578365  
Fax    
Email  dr.saurabhortho@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ritvik Sharma 
Designation  Junior resident 
Affiliation  All India Institute Of Medical Sciences, Jodhpur 
Address  Dept. of orthopaedics, AIIMS Jodhpur
Basni

RAJASTHAN
342005
India 
Phone  07009892538  
Fax    
Email  ritz.ptk@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur, Basni, Jodhpur 342005, Rajasthan, India 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS Jodhpur, Basni, 342005 
Type of Sponsor  Research institution and hospital 
 
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 Ritvik Sharma  AIIMS Hospital  Department of Orthopaedics, Room no. 52
Jodhpur
RAJASTHAN 		 07009892538

ritz.ptk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fixed-bearing unicompartmental knee arthroplasty  Patients randomized to this group will undergo unicompartmental knee arthroplasty using a fixed-bearing tibial insert for isolated unicompartmental knee osteoarthritis. Surgical technique, peri-operative management, and rehabilitation protocol will be identical to the intervention group, except for the type of bearing used. Duration~ 1 hour 
Intervention  Mobile-bearing unicompartmental knee arthroplasty  Patients randomized to this group will undergo unicompartmental knee arthroplasty using a mobile-bearing tibial insert for isolated unicompartmental knee osteoarthritis. The procedure will be performed using a standard surgical technique by experienced surgeons, following institutional protocol. Peri-operative care and rehabilitation will be standardized across both groups. Duration~ 1 hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Primary Medial UKA
Antero medial compartment varus OA knee
Flexion more than 90 degrees
FFD less than 10 degrees
Varus deformity less than 20 degrees 
 
ExclusionCriteria 
Details  Graded 2 to 4 degenerative changes of lateral compartment
history of lateral meniscectomy
anterior cruciate ligament absence
Revision surgery
Previous lower limb surgery 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome of this study is to compare functional outcomes of the 2 groups using scores lik KSS, KFS, IKDC, WOMAC, KOOS  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome of this study is compare functional and clinical outcomes between 2 groups in the form of blood investigations and gait analysis etc  6 months 
 
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)   24/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/01/2026 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ritz.ptk@gmail.com].

  6. For how long will this data be available start date provided 18-07-2026 and end date provided 18-07-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is a randomized controlled trial comparing and asssessing clinical and functional outcomes in patients with Medial knee osteoarthritis managed by UKA mobile bearing vs UKA fixed bearing.To compare and determine 6-month patient reported outcome measures and post operative adverse effects in patients undergoing mobile bearing and fixed bearing UKA.  
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