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CTRI Number  CTRI/2026/01/102256 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A Study Comparing Traditional and Robotic Knee Replacement Surgery in People with Arthritis in Both Knees 
Scientific Title of Study   To compare clinical and radiological outcomes of conventional and robotic total knee replacement in patients with osteoarthritis of bilateral knee joint Academic trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raghunath S 
Designation  Junior Resident 
Affiliation  AIIMS Mangalagiri 
Address  OPD- 236 AIIMS MANGALAGIRI,
Mangalagiri, Andhra Pradesh 522503
Guntur
ANDHRA PRADESH
522503
India 
Phone  8098768903  
Fax    
Email  m02jan025026@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Nataraj A R 
Designation  Professor and Head of the department Orthopaedic 
Affiliation  AIIMS Mangalagiri 
Address  OPD-236 AIIMS MANGALAGIRI,
Mangalagiri, Andhra Pradesh 522503
Guntur
ANDHRA PRADESH
522503
India 
Phone  9482183670  
Fax    
Email  natadoc@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Nataraj A R 
Designation  Professor and Head of the department Orthopaedic 
Affiliation  AIIMS Mangalagiri 
Address  OPD-236 AIIMS MANGALAGIRI,
Mangalagiri, Andhra Pradesh 522503
Guntur
ANDHRA PRADESH
522503
India 
Phone  9482183670  
Fax    
Email  natadoc@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
AIIMS Mangalagiri MAngalagiri, Guntur, Andhra Pradesh- 522503 India 
 
Primary Sponsor  
Name  Dr Raghunath 
Address  OPD- 236 AIIMS Mangalagiri Mangalagiri, Guntur Andhra Pradesh 522503 
Type of Sponsor  Other [Self Funding] 
 
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 Raghunath S  Room no.236, Second floor, Orthopaedics Department, AIIMS Mangalagiri  AIIMS MANGALAGIRI, Mangalagiri, Andhra Pradesh 522503
Guntur
ANDHRA PRADESH 
08098768903

m02jan025026@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS MANGALAGIRI  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Total knee Replacement  Manually total knee replacement will be done 
Intervention  Robotic Total knee Replacement  Robot assisted knee replacement will be done 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a) Patients diagnosed with bilateral knee osteoarthritis with varus deformity .
b) patients aged between 50 and 80 years and also medically fit for bilateral TKR .
c) patient with ROM difference between bilateral knee not more than 10 degree and varus deformity difference less than 5 degree.
d) Patients willing to undergo one knee conventional and other knee robotic TKR after understanding all the possible complications and gives audiovisual consent for the procedure.

 
 
ExclusionCriteria 
Details  a) Patients with inflammatory arthritis (e.g., rheumatoid arthritis).
b) Patients with a history of knee infections or previous knee surgeries.
c) patient with neuromuscular disorders affecting lower limb function .
d) Patients with fixed deformities of the knee joint
e) Patients with any contraindications for surgery like severe cardiac ,renal ,pulmonary and any other severe systemic illness.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To evaluate and compare functional outcomes by using standardised scoring systems- WOMAC ,OKS , VAS at defined postoperative intervals .
• To assess radiological outcomes such as implant positioning and alignment between robotic and conventional TKR using HKA angle, femoral coronal component angle (FFC),tibial coronal component angle (FTC),posterior tibial slope angle (PSA).
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 

• To compare operative parameters such as duration of surgery , intra operative blood loss and need for soft tissue releases between robotic and conventional TKR 
on the day of surgery 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 
Date of First Enrollment (India)   09/02/2026 
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="1"
Months="6"
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 - NO
Brief Summary  
Comparing clinical and radiological outcomes of conventional and robotic total knee replacement (TKR) in patients with bilateral knee osteoarthritis is a pertinent area of research given the increasing adoption of robotic assistance. This type of study typically aims to determine if the perceived precision and potential benefits of robotic-assisted surgery translate into superior patient outcomes compared to traditional manual techniques.
A well-designed study would involve a cohort of patients suffering from end-stage osteoarthritis affecting both knees. These patients would ideally undergo TKR using both conventional and robotic techniques, either with one knee receiving conventional and the other robotic (a within-patient comparison, carefully considering potential confounding factors), or by randomizing patients to receive either conventional or robotic surgery for both knees.
The primary clinical outcomes would include patient-reported outcome measures (PROMs) such as the Knee Society Score (KSS), Oxford Knee Score (OKS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). These scores capture pain levels, functional limitations, and overall patient satisfaction, providing a holistic view of the recovery process and quality of life post-surgery. Range of motion and gait analysis would also be critical clinical assessments.
Radiological outcomes would focus on implant positioning and alignment, which are hypothesized to be more precise with robotic assistance. This would involve post-operative X-rays and potentially CT scans to assess parameters like component angles (femoral and tibial), joint line restoration, and mechanical axis alignment. The incidence of malalignment or outliers beyond acceptable ranges would be a key comparative metric.
Secondary outcomes could include surgical time, blood loss, length of hospital stay, and complication rates (e.g., infection, deep vein thrombosis, revision surgery). The study would need to ensure adequate follow-up periods (e.g., 1, 2, and 5 years) to evaluate long-term implant survival and functional stability. While robotic assistance often promises enhanced precision, the core question is whether this translates into clinically meaningful benefits for patients, such as reduced pain, improved function, and greater implant longevity, compared to the well-established conventional method. The findings would help inform surgical decision-making and potentially guide future advancements in TKR techniques.
 
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