| CTRI Number |
CTRI/2025/04/085888 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Experiences, Satisfaction and Quality of Life with Physiotherapy after Total Knee Arthroplasty |
|
Scientific Title of Study
|
Experiences, Satisfaction and Quality of Life with Physiotherapy during follow-up after 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 |
SALONI SHETTY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
|
| Address |
Yenepoya Physiotherapy College, Physiotherapy OPD, 7th floor,
Deralakatte, Mangalore
D.K, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9902401904 |
| Fax |
|
| Email |
salonishetty@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Asir John Samuel |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
Yenepoya Physiotherapy College, Professor Cabin, 7th floor,
Deralakatte, Mangalore
D.K, Karnataka
KARNATAKA
575018
India |
| Phone |
8059930222 |
| Fax |
|
| Email |
asirjohnsamuel@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SALONI SHETTY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
|
| Address |
Yenepoya Physiotherapy College, Physiotherapy OPD, 7Th floor,
Deralakatte, Mangalore
D.K, Karnataka
KARNATAKA
575018
India |
| Phone |
9902401904 |
| Fax |
|
| Email |
salonishetty@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD, Yenepoya Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Saloni Shetty |
| Address |
Yenepoya Physiotherapy College,
Deralakatte, Mangalore- 575018
D.K. Karnataka |
| Type of Sponsor |
Other [Self funded study ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saloni Shetty |
Yenepoya Medical College and Hospital |
Yenepoya Medical College and Hospital, Physiotherapy OPD, Deralakatte, Managlore- 575018, D.K, Karnataka
Dakshina Kannada
KARNATAKA |
09902401904
salonishetty@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have received physiotherapy rehabilitation post total knee arthroplasty for 6 days at hospital
2. Patients who have undergone unilateral total knee arthroplasty prior to 1 month of the interview
3. Patients who can understand and speak English or Kannada language
4. 45-60 years
5. All genders
|
|
| ExclusionCriteria |
| Details |
1. Patients with any other musculoskeletal/ pathological condition
2. Any age-related co morbidities
3. Any post surgical complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Semi Structured Interview Guide |
8 open ended questions |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "11"
Final Enrollment numbers achieved (India)="11" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/05/2025 |
| Date of Study Completion (India) |
21/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
3 published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study
will employ a qualitative research design, utilizing semi structured open-ended
interview guide developed by researcher along with supervisor and with individuals
who had undergone physiotherapy for total knee arthroplasty (TKA). Criterion
sampling will be used for sampling strategies, Braun and Clarke Thematic
analysis will be applied to extract meaningful patterns and themes from the
gathered data. |