| CTRI Number |
CTRI/2022/10/046104 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
25/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability and validation of the Marathi version of Knee injury and Osteoarthritis Outcome Scale for patients after Total Knee Replacement surgery (KOOS, JR.) |
|
Scientific Title of Study
|
Reliability and validation of the Marathi version of Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR.) questionnaire in patients 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 |
Nupur Shah |
| Designation |
MPT student Masters in musculoskeletal physiotherapy |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
Department of Musculoskeletal physiotherapy,1st floor,Sancheti institute college of physiotherapy, Thube Park, Shivajinagar, Pune, Maharashtra, 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9819515513 |
| Fax |
|
| Email |
nupurshah1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sona Kolke |
| Designation |
Associate Professor, Department of Musculoskeletal Physiotherapy. |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
Department of Musculoskeletal physiotherapy,1st floor,Sancheti institute college of physiotherapy, Thube Park, Shivajinagar, Pune, Maharashtra, 411005.
Pune
MAHARASHTRA
411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sona Kolke |
| Designation |
Associate Professor, Department of Musculoskeletal Physiotherapy |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
Department of Musculoskeletal physiotherapy,1st floor,Sancheti institute college of physiotherapy, Thube Park, Shivajinagar, Pune, Maharashtra, 411005.
Pune
MAHARASHTRA
411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti institute college of physiotherapy |
| Address |
11/12, Sancheti institute college of physiotherapy, Thube Park, Shivajinagar, Pune, Maharashtra, 411005. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nupur Shah |
Sancheti Institute of Orthopaedics and Rehabilitation |
Sancheti Institute of Orthopaedics and Rehabilitation,11/12,Thube Park,Shivajinagar,Pune,Maharashtra
Pune
MAHARASHTRA |
9819515513
nupurshah1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute Orthopaedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of either gender between the age group of 45 to 80.
2.Subjects undergone Total Knee Arthroplasty Surgery.
3.Subjects who are able to read and speak Marathi as well as English language.
|
|
| ExclusionCriteria |
| Details |
1.Unwilling to participate in this study.
2.Revision Knee Arthroplasty
3.Postoperative complications like bleeding, wound complication, thromboembolic disease, neural deficit, vascular injury.
4.Associated comorbidities like chronic obstructive pulmonary disease, morbid obesity, chronic kidney disease, hepatitis C and cirrhosis.
5.Presence of other significant rheumatic disease or any other inflammatory arthritis variants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Marathi version of Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR.) |
Post-operative day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR.)
2.Marathi version of Knee injury and Osteoarthritis Outcome Score (KOOS) |
Post-operative day 4 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/10/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a methodological type of study with an aim to find out the reliability and validity of the Marathi version of Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR.) questionnaire in patients following Total Knee Arthroplasty. Original KOOS JR questionnaire will be translated into marathi language as per the guidelines made by American Association of Orthropaedic Surgeons. Its reliability will be checked by administering the original KOOS JR questionnaire and marathi version of KOOS JR to the patients following TKA with an interval of 48 hours in between. Marathi version of KOOS questionnaire will be used to check the validity. |