| CTRI Number |
CTRI/2019/11/021948 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
07/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the outcome of total knee arthroplasty |
|
Scientific Title of Study
|
Comparison of functional outcome and patient reported outcome in cruciate retaining versus posterior stabilising total knee arthroplasty: A prospective randomised control clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSHAN YADAV |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Ab1 ward , 1st floor, department of orthopaedics , AIIMS , New Delhi,110029
New Delhi
DELHI
110049
India |
| Phone |
00917982783975 |
| Fax |
|
| Email |
yadavroshan1110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CS Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Ab1 ward, 1st floor , DEpartment Of Orthopaedics, AIIMS,new delhi,110029,india
New Delhi
DELHI
110029
India |
| Phone |
00917982783975 |
| Fax |
|
| Email |
csyadavortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ROSHAN YADAV |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Ab1 ward, 1st floor, Department of orthopaedics,AIIMS,new delhi,110049,india
New Delhi
DELHI
110049
India |
| Phone |
00917982783975 |
| Fax |
|
| Email |
yadavroshan1110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department Of OrthopaedicsAIIMSNew Delhi |
| Address |
Sir aurobindo marg, ansari nagar,ansari nagar east , new delhi,delhi,110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| department of orthopaedics |
aiims, new delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roshan Yadav |
AIIMS,New Delhi |
Ab1 ward, Department of orthopaedics,sir aurobindomarg, new delhi,delhi,110029
New Delhi
DELHI |
7982783975
roshan2365@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
one group of patients will undergo cruciate retaining total knee arthroplasty and other group will undergo posterior stabilising total knee arthroplasty |
| Intervention |
total knee arthroplasty |
one group of patients will undergo cruciate retaining total knee arthroplasty and other group will undergo posterior stabilising total knee arthroplasty |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient undergoing b/l total knee arthroplasty during study period using same implant
2)Varus deformity <30 degrees
3)Age between 50 years and 85 years
4)Patient having primary osteoarthritis
5)Patient giving consent for surgery |
|
| ExclusionCriteria |
| Details |
1) Revision cases of total knee arthroplasty
2) Post traumatic, post tb knee
3) patients with restricted range of motion <90 degrees
4) patients not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of functional and patient reported outcome in cruciate retaining versus posterior stabilising total knee arthroplasty |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the FJS and OKS of cruciate retaining tkr
2) To assess the FJS and OKS of posterior stabilising total knee arthroplasty |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
25/11/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
I am Dr Roshan Yadav, junior resident , department of Orthopaedics , AIIMS, New delhi. This is study of my ongoing postgraduate thesis- comparision of functional and patient reported outcome in cruciate retaining versus posterior stabilising total knee arthroplasty. |