| CTRI Number |
CTRI/2017/10/010236 [Registered on: 27/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing two techniques(computer based vs accelerometer based) of navigated total knee replacement surgery |
|
Scientific Title of Study
|
A prospective randomized study to compare imageless large console computer assisted navigation vs accelerometer based portable navigation technique of total knee replacement |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun M |
| Designation |
junior resident |
| Affiliation |
All India Institute of Medical sciences, new delhi |
| Address |
AB 1 ward, dept of orthopedics, AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9013225679 |
| Fax |
|
| Email |
arunmortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajesh Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences, new delhi |
| Address |
Room No. 5019, Teaching Block, Department of Orthopedics, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868397112 |
| Fax |
|
| Email |
rmalhotra62@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun M |
| Designation |
junior resident |
| Affiliation |
All India Institute of Medical sciences, new delhi |
| Address |
Department of Orthopedics, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013225679 |
| Fax |
|
| Email |
arunmortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Ansari nagar, New Delhi, Delhi, 110029, INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Ansari Nagar, New Delhi, Delhi, India, 110029 |
| Type of Sponsor |
Government 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 Arun M |
All India Institute of medical sciences |
AB 1 ward, department of orthopedics
New Delhi
DELHI |
9013225679
arunmortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee, All India Institue Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
primary or secondary osteoarthritis knee to be suitable for total knee replacement., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
accelerometer based portable navigation technique |
portable hand held, accelerometer based disposable device used to provide orientation of knee in order to achieve proper mechanical alignment of lower limb in total knee replacement |
| Comparator Agent |
imageless large console computer based porable navigation technique |
computer assisted device which uses infrared rays to provide orientation of knee in order to achieve proper mechanical alignment of lower limb in total knee replacement. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with primary or secondary osteoarthritis knee to be suitable for total knee replacement.
2 Patients undergoing primary knee arthroplasty.
3 Patients willing to give consent for the study.
|
|
| ExclusionCriteria |
| Details |
1 Patients undergoing simultaneous hip and knee arthroplasty.
2 Patients undergoing conventional free hand total knee replacement.
3 Refusal to give consent.
4 Patients with below knee deformity/ amputation.
5 Patients undergoing revision knee surgery.
6 Patients with implant in tibial or femoral medullary canal precluding placement of pin for Large Console, Imageless Computer assisted navigation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced intra operative tourniquet time |
at the time of surgery (intra-operative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mechanical alignment |
2 weeks, 3 months, 6 months and 12 months from the date of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/02/2016 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the accelerometer based portable navigation technique and Large Console, Imageless Computer assisted navigation of total knee replacement in terms of 1 Intra op tourniquet time and blood loss 2 Coronal, sagittal and rotational alignment of the Femoral and tibial components 3 Mechanical alignment of the lower limb 4 Radio-logical outcome and joint position 5 Pin site complications 6 Patient satisfaction following total knee replacement |