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CTRI Number  CTRI/2025/11/098189 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Frailty as a predictor of post operative outcomes in elderly patients undergoing total knee arthroplasty 
Scientific Title of Study   Frailty as a predictor of post operative outcomes in elderly patients undergoing total knee arthroplasty A Prospective Observational Study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devidas T U 
Designation  Post Graduate Department of Anaesthesiology  
Affiliation  Kasturba Medical College Mangalore 
Address  Room No 325 Kappriguda Mens Hostel Kasturba Medical College Mangalore Light house hill Road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9048753345  
Fax    
Email  devidastu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sumesh T Rao 
Designation  Head of Department of Anaesthesiology  
Affiliation  Kasturba Medical College Mangalore  
Address  Head of Department of Anaesthesiology Kasturba Medical College Mangalore Light house hill Road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449167895  
Fax    
Email  sumesh.rao@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sumesh T Rao 
Designation  Head of Department of Anaesthesiology  
Affiliation  Kasturba Medical College Mangalore  
Address  Head of Department of Anaesthesiology Kasturba Medical College Mangalore Light house hill Road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449167895  
Fax    
Email  sumesh.rao@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Devidas T U 
Address  Post Graduate, Department of Anaesthesiology Kasturba Medical College Mangalore 575001 Dakshina Kannada Karnataka India 
Type of Sponsor  Other [Nil] 
 
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 Devidas T U   Kasturba Medical College Hospital   Department of Anaesthesiology Kasturba Medical College Hospital Nandigudda Rd, Attavar, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA 
9048753345

devidastu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College Mangalore   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 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients undergoing total knee arthroplasty
ASA 1 2 3
Age 60 years-85 years 
 
ExclusionCriteria 
Details  Patients under ASA 4 5 6
Patients who are not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess preoperative frailty levels in patients undergoing total knee arthroplasty and to analyse postoperative complications and recovery time  1 week and 3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the association between frailty & hospital stay duration   7th day 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   24/12/2025 
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="2"
Months="1"
Days="29" 
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   This prospective observational study aims to evaluate how preoperative frailty affects postoperative outcomes in elderly patients undergoing Total Knee Arthroplasty (TKA). Frailty is a clinical syndrome characterized by reduced physiological reserve and increased vulnerability to stress, and it is considered an independent predictor of surgical risk.

Rationale
Although TKA is effective for severe knee osteoarthritis, many elderly candidates are frail. Frail patients tend to have:
 • Higher rates of postoperative complications
 • Delayed recovery and prolonged hospital stay
 • Increased need for post-discharge rehabilitation facilities

However, frailty assessment is not routinely done in preoperative evaluation. This study intends to bridge this gap.

Study Objectives
Primary Objectives:
 1. Assess preoperative frailty in patients scheduled for TKA.
 2. Analyze postoperative complications and recovery patterns.

Secondary Objective:
 • Determine the relationship between frailty level and length of hospital stay.

Methodology
 • Study Setting: Three hospitals under Kasturba Medical College, Mangalore.
 • Participants: Patients aged 60–85 years, ASA Grade I–III, undergoing TKA.
 • Sample Size: 83 participants determined based on prevalence data.
 • Study Tool: FRAIL Scale, assessing fatigue, resistance, ambulation, illness burden, and weight loss.
 • Follow Up: Postoperative assessments at 24 hrs, day 7, 6 weeks, and 3 months.

Outcomes Measured
 1. Pain (VAS score)
 2. Postoperative complications (classified using Clavien-Dindo system)
 3. Recovery time and functional improvement
 4. Length of hospitalization

Data Analysis
Statistical tests (paired t-test, chi-square, ANOVA) will be used with significance set at p < 0.05.

Expected Impact
Preoperative frailty screening will help:
 • Identify high-risk patients early,
 • Guide personalized care and rehabilitation plans,
 • Improve surgical decision-making and patient counseling
 
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