| CTRI Number |
CTRI/2024/02/062787 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision Study Between Metal Backed Tibia and All Poly Component in TKR |
|
Scientific Title of Study
|
Comparision of Radiological and Functional Outcome of Metal Backed Fixed-bearing Tibial Base Plate Versus All Polyethylene Tibia in 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 |
S Lohitesh |
| Designation |
MCh Resident in Joint Replacement and Reconstruction |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Room no 1, D-block, orthopaedic department, All India Institute of Medical Sciences, Raipur
Room no 1, D-block, orthopaedic department, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
07701941842 |
| Fax |
|
| Email |
lohiteshsaparey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alok C Agrawal |
| Designation |
Head of the Department, Orthopedics |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Room no 1, D-block, Orthopedic department, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881939 |
| Fax |
|
| Email |
profdralokcagrawal@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
S.Lohitesh |
| Designation |
MCh Resident in Joint Replacement and Reconstruction |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Room no 1, D-block, Orthopedic department, All India Institute of Medical Sciences, Raipur
Room no 1, D-block, Orthopedic department, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881939 |
| Fax |
|
| Email |
lohiteshsaparey@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
All India Institute of Medical Sciences, Raipur |
| 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 S Lohitesh |
All India Institute of Medical Sciences, Raipur |
room no 1, Orthopedic department, D-block, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH |
07701941842
lohiteshsaparey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
total knee replacement with all polyethylene tibial component |
2 years |
| Intervention |
total knee replacement with metal backed fixed-bearing tibial base plate |
2 years |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who are willing for surgery
2. Age group more than 40 years and less than 80 years
3. Patients who has oxford knee score of less than 30
4. Patients with grade 3 & 4 osteoarthritis as per Kellgren Lawrence Osteoarthritis Classification
|
|
| ExclusionCriteria |
| Details |
1. Patient unwilling to give consent
2. Revision arthroplasty
3. Routine contraindications to TKA (active sepsis, Charcot arthropathy)
4. Metal hypersensitivity
5. Patients whose mental function (neurological and psychological disorders) preclude them from responding to our standard questionnaires
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the radiological and functional outcome of metal backed fixed-bearing tibial base plate versus all polyethylene tibia in total knee arthroplasty. |
6 months after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the radiological and functional outcome of metal backed fixed-bearing tibial base plate in total knee arthroplasty
2. To study the radiological and functional outcome of all polyethylene tibial component in total knee arthroplasty
|
6 months after the surgery |
|
|
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)
|
28/02/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Osteoarthritis is most the common degenerative disease in orthopedic practice. It is characterized by progressive destruction of cartilage, joint space narrowing, subchondral cyst formation, synovial inflammation, marginal osteophyte formation and deformity. Total knee replacement is a successful procedure and is an excellent treatment option for individuals with symptomatic osteoarthritis in at least 2 of the 3 compartments of knee who have failed conservative treatment. Two types of tibial implants can be used today in total knee replacement: a metal-backed modular device or an all-poly tibial implant. The aim of this study is to assess and compare the radiological and functional outcome of metal backed fixed-bearing tibial base plate and all polyethylene tibia in total knee arthroplasty. |