| CTRI Number |
CTRI/2025/10/095817 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nursing care guidelines for patients of knee replacement surgery. |
|
Scientific Title of Study
|
Development, Validation of a new nursing care protocol for total knee replacement and assessment of comparative efficacy as against conventional practice for improving recovery of total knee replacement patients in the tertiary care hospital. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Meera Pohane |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Medical Surgical Nursing, Ground Floor, SMCON Building, DMIHER Campus, Hirapur Salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
9767985878 |
| Fax |
|
| Email |
meerah32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor and Principal |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Medical Surgical Nursing, Ground Floor, SMCON Building, DMIHER Campus, Hirapur Salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor and Principal |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Medical Surgical Nursing, Ground Floor, SMCON Building, DMIHER Campus, Hirapur Salod
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Ranjana Sharma |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Orthopedics, 2nd Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9960027855
ranjanasharma1234@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nursing Care Protocol for Knee replacement cases |
A specially developed nursing care protocol will be implemented for post-operative cases of knee replacement. |
| Comparator Agent |
Routine nursing Care |
Routine nursing care protocol will be implemented for post-operative cases of knee replacement. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with conditions requiring total knee replacement like osteoarthritis, rheumatoid arthritis, post-traumatic arthritis.
2.Those who are willing to participate in the study
3.Those who can read and write either of Marathi/Hindi and English.
|
|
| ExclusionCriteria |
| Details |
1. Those who involved in other similar research projects.
2. Patients undergoing revision total knee replacement or other major joint surgeries.
3. Those who have co-morbid disease condition |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Signicant outcomes with new nursing care protocol for total knee replacement patients. |
Assessment will be done at 4 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="0"
Days="0" |
|
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 study is a randomized, participant blinde, sealed opaque envelope, observation trial comparing development, Validation of a new nursing care protocol for total knee replacement and assessment of comparative efficacy as against conventional practice for improving recovery of total knee replacement patients in the tertiary care hospital. The outcomes of study are early promotion of wound healing. |