FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/048118 [Registered on: 14/12/2022] Trial Registered Prospectively
Last Modified On: 09/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Long- term functioning, wellbeing and mental status following knee surgery 
Scientific Title of Study   Long- term Quality of Life, Functional Activities and Psychological Status following Total Knee Arthroplasty 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saidan Shetty  
Designation  MPT (Musculoskeletal Sciences), PhD Scholar 
Affiliation  Manipal Academy of Higher Education (MAHE) 
Address  PhD Scholar, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9008858059  
Fax    
Email  saidanshetty1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bincy M George  
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education (MAHE) 
Address  Associate Professor, Department of Basic Medical Sciences (DBMS), Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  bincy.george@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Saidan Shetty 
Designation  MPT (Musculoskeletal Sciences), PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  PhD Scholar, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9008858059  
Fax    
Email  saidanshetty1@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal  
Manipal Academy of Higher Education (MAHE), Manipal  
 
Primary Sponsor  
Name  Saidan Shetty  
Address  Manipal Academy of Higher Education (MAHE), Manipal 
Type of Sponsor  Other [Self] 
 
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 
Saidan Shetty  Kasturba Hospital, Manipal  Kasturba Hospital, Department of Physiotherapy, Department of Orthopedics, Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 9008858059

saidanshetty1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with primary knee osteoarthritis who have undergone TKA
2. Gender: Both males and females 
 
ExclusionCriteria 
Details  1. Occurrence of mortality
2. Unreachable either through telephone
3. Who are not willing to participate in the study
4. Patients who had neurological deficits, inflammatory arthritis with multiple joint involvement and post traumatic arthritis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of Life:
1. Knee Injury and Osteoarthritis Outcome Score (KOOS)
2. Short Form 36 Health Survey Questionnaire (SF-36)
 		 One time assessment over a telephonic call 
 
Secondary Outcome  
Outcome  TimePoints 
Psychological factors:
1. Fear avoidance/ Kinesiophobia: Tampa Scale of Kinesiophobia (TSK)
2. Central Sensitization: Central Sensitization Inventory (CSI)
3. Depression: Patient Health Questionnaire (PHQ)
4. Catastrophising: Pain Catastrophizing Scale (PCS)
5. Stress: Perceived Stress Scale (PSS)
6. Self- efficacy: Arthritis Self Efficacy Scale 		 One time assessment over a telephonic call 
 
Target Sample Size   Total Sample Size="912"
Sample Size from India="912" 
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)   15/12/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL till date 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction:

Knee Osteoarthritis (OA) is a debilitating condition that affects a large population across the globe and is one of the primary causes of pain and disability. (Nelson et al., 2017) It is the most frequent joint disease with a prevalence of 22% to 39% in India. (Muhammad et al., 2021). Along with structural changes and functional limitations, it has shown to reduce overall quality of life. Total knee arthroplasty (TKA) is the most effective and most preferred treatment plan for the end stage osteoarthritis. It is frequently implemented when the attempted conservative options fail to relieve disabling symptoms. There are various surgical approaches in TKA, which include the medial parapatellar approach, midvastus approach, subvastus approach and the lateral parapatellar approach (Vaishya et al., 2016). Most of these procedures cause significant trauma to the extensor mechanism of the knee joint. (Hall MC et al., 2006; Vaishya et al., 2016; Aslam et al., 2017). While TKA helps in reduction of pain and provides a functional range of motion of knee, weakness of the muscles surrounding the knee could still be present after surgery. This could hinder performance of functional activities such as sit to stand, walking, and stair climbing. (Davidson et al., 2013; Yoshida et al., 2013; Thomas et al., 2014; Judd et al., 2021). Hence, understanding the ability to perform functional activities during the phase-wise rehabilitation program post TKA is imperative.

Assessing quality of life is an important step in evaluating well- being, disease progression, and intervention efficacy. The co-morbidities and low pre- operative quality of life is found to be the strongest predictor of post- operative quality of life in patients post TKA. Quality of life in TKA patients is affected primarily because of pain and disability. Understanding the long-term quality of life post TKA is important to identify the various factors which influence quality of life and methods to improve it (Gunaratne et al., 2017, Vitaloni et al., in 2019). Multiple  factors  have  been  associated  with  poor  outcomes  and  dissatisfaction after TKA, including sociodemographic factors (eg, older age, living alone), preoperative status (eg, lower functional ability, poor patient-reported outcomes, severe  degenerative  changes),  intraoperative  factors  (eg,  prosthesis  used,  surgical  technique,  alignment),  postoperative factors (eg, surgical complications, lower physical activity, lower overall health scores) and psychological well-being(Gunaratne et al., 2017). Depending on the findings, we can work on the factors hindering the functional status, quality of life, and psychological status of these patients. This would help in achieving better patient prognosis post TKA. (Hall MC et al., 2006; Hegde et al., 2021; Harikesavan K et al.,2019; Castrodad ICMD et al., 2019). Therefore, the aim of this study is to assess the Long- term Quality of Life, Functional Activities and Psychological Status following Total Knee Arthroplasty in Knee Osteoarthritis.


Need for the study: 

Even if pain is reduced post TKA, mobility is not fully achieved in these patients. The wear and tear of the artificial joint due to loading is not clearly understood. Most of these patients compensate by using other muscles and trick movements. Therefore, even if pain decreases, TKA might have significant changes in functional activities and quality of life. There is dearth of literature on long- term quality of life and functional activities after Total Knee Arthroplasty. The factors influencing the long-term quality of life in TKA patients is not known especially in Indian population. The influence of various existing co-morbidities on long term quality of life and functional outcomes is less studied. There are very few studies which have evaluated the psychological status of the individual following TKA on a long- term basis. Understanding of quality of life, functional status, and the psychological status will help in planning and developing long term treatment strategies. This would be beneficial to minimize the impairments and promote early recovery and reintegration to community, work, and efficiently preforming activities of daily living. It would also help in understanding the factors to be considered to improve long term quality of life, functional status, and psychological wellbeing of these patients.


Objectives: 

Primary objectives:

1. To assess the Long- term Quality of Life after Total Knee Arthroplasty using standardized questionnaires following Total Knee Arthroplasty

2. To assess the Functional activities in terms of activities of daily living, community participation, and work status following Total Knee Arthroplasty

3. To determine the psychological status in terms of kinesiophobia, catastrophizing, stress, anxiety, and depression following Total Knee Arthroplasty

Secondary objectives:

1. To explore the factors influencing long- term quality of life following Total Knee Arthroplasty

2. To identify the influence of existing comorbidities (such as diabetes) on quality of life and functional activities following Total Knee Arthroplasty

3. To determine the association of clinical characteristics with quality of life, functional activities, and psychological status following Total Knee Arthroplasty

4. To identify the psychological predictors of quality of life following Total Knee Arthroplasty

 

Methodology:

Study participants include patients with knee osteoarthritis who have undergone Total Knee Arthroplasty in Kasturba Hospital, Manipal. Records of patients admitted for Total Knee Arthroplasty from January 2015 to December 2021 will be obtained. Screening of the patients will be done based on inclusion and exclusion criteria. The details of the patient about Demographic characteristic (age, gender, BMI, socioeconomic status, educational level, occupation), Surgery (date, type, post-operative care, duration of stay in hospital), past medical history of comorbidities, post- operative rehabilitation history, present complaints and current physiotherapy treatment (if any) would be collected. The patients will be contacted through their telephone number and the therapist will be explaining about the study and telephonic consent from the patients will be obtained. After consent, time for the interview will be fixed. A telephonic interview of the patient will be done using the various self reported questionnaires mentioned below.

Outcomes:

Function and Quality of Life: Knee Injury and Osteoarthritis Outcome Score (KOOS), Short Form 36 Health Survey Questionnaire (SF-36)

Psychological factors: Fear avoidance/ Kinesiophobia: Tampa Scale of Kinesiophobia (TSK), Central Sensitization: Central Sensitization Inventory (CSI), Depression: Patient Health Questionnaire (PHQ), Catastrophising: Pain Catastrophizing Scale (PCS), Stress: Perceived Stress Scale (PSS), Self- efficacy: Arthritis Self Efficacy Scale

 

Statistical Analysis:

The data will be analyzed by using SPSS version 20.0. Descriptive statistics will be used to describe demographic variables and quantify the quality of life, functional activity, and psychological status. Correlation analysis will be done to find the relationship between the variables. Linear regression will be used to evaluate the psychological predictors of quality of life. The association of clinical characteristics with Quality of Life, Functional Activity and Psychological status questionnaire scores will be assessed using Chi square test. Level of significance will be set at p<0.05.


 
Close