| CTRI Number |
CTRI/2018/12/016637 [Registered on: 12/12/2018] Trial Registered Prospectively |
| Last Modified On: |
11/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the functional outcomes and perceived benefits of the patients with total knee arthoplasty |
|
Scientific Title of Study
|
A study to assess the functional outcomes and the perceived benefits
among the patients with total knee arthroplasty visiting the orthopaedic OPD of Kasturba
Hospital Manipal |
| Trial Acronym |
OPD out patient department |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sabina Sharma |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8967584749 |
| Fax |
|
| Email |
sabina25sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sulochana B |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844995784 |
| Fax |
|
| Email |
sulochana.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prima Jenevive Jyothi D Souza |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986244210 |
| Fax |
|
| Email |
prima.jj@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sabina Sharma |
| Address |
Manipal College of Nursing MAHE Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prima D souza |
Manipal college of Nursing Manipal |
| Sulochana B |
Manipal college of Nursing Maipal. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sabina Sharma |
Kasturba Hospital Manipal |
Unit V,orthopedic out patient department of Kasturba hospital, MAHE Manipal.
Udupi
KARNATAKA |
8967584749
sabina25sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The data will be collected from the patient who visit the orthopaedic OPD after the
three months of total knee arthoplasty surgery and their preoperative data will be collected through the patients file |
|
| ExclusionCriteria |
| Details |
A person diagnosed with mental disorders and mental retardation and the patient with complex health issues |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of functional outcomes and the perceived benefits using the self developed observational tool and the standardized tool. |
at the one month after the surgery (total knee arthoplasty). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved functional outcomes as compared to preoperative status with perceived benefit |
assessed after the one month of surgery on visit to out Patient department. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/12/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is prospective observational study to assess the functional outcomes and the perceived benefits of the patients with total knee arthroplasty visiting the orthopaedic OPD of Kasturba Hospital, Manipal. Population are the orthopedic patients who underwent knee surgery three months before and has come to out patient department for follow. Anonimity of the participants will be protected. Administrative permission has been taken from the college and clearance from Institutional Ethical committe is awaited but the refrence number has been alloted. |