| CTRI Number |
CTRI/2025/03/081644 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical outcomes of total knee replacement in patients with arthritic knee with and without patellar replacement: A Randomized Controlled Study |
|
Scientific Title of Study
|
Functional and radiological outcome in Total knee arthroplasty with and without patellar resurfacing : A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jagprit Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of medical Sciences, Raipur |
| Address |
Department of Orthopaedics, All India Institute of medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8360551525 |
| Fax |
|
| Email |
jagprit7singh7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.Dr. Alok C Agrawal |
| Designation |
Professor and Head of department |
| Affiliation |
All India Institute of medical Sciences, Raipur |
| Address |
Department of Orthopaedics, All India Institute of medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9425151634 |
| Fax |
|
| Email |
Dralokcagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jagprit Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of medical Sciences, Raipur |
| Address |
Department of Orthopaedics, All India Institute of medical Sciences, Raipur
CHHATTISGARH
492099
India |
| Phone |
8360551525 |
| Fax |
|
| Email |
jagprit7singh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur , Chhattisgarh 492099 |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
All India Institute of Medical Sciences, Raipur, Chhattisgarh 492099 |
| 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 |
| Jagprit Singh |
All India Institute of medical Sciences, Raipur |
Department of orthopaedics, All India Institute of Medical Sciences, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH |
08360551525
jagprit7singh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
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 |
Total knee Arthroplasty |
Total knee Arthroplasty with patellar resurfacing (In this group patient will undergo Total knee replacement with patellar replacement) |
| Comparator Agent |
Total knee Arthroplasty |
Total knee Arthroplasty without patellar resurfacing(In this group patient will undergo Total knee replacement without patellar replacement) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Candidates having primary OA knee being operated in the department of orthopaedics,
AIIMS Raipur
2. Patients with valid informed consent and medically fit to undergo surgical procedure
3. First implant knee prosthesis surgery. |
|
| ExclusionCriteria |
| Details |
1. Patient with serious medical conditions such as hemophilia.
2. Those who have undergone revision total knee arthroplasty.
3. Those who have already undergone total hip arthroplasty / ankle arthroplasty.
4. Those who have patellar fracture or patellar instability.
5. Those who have undergone previous extensor mechanism, high tibial osteotomy.
6. Candidates with neurological deficiency in the lower limb. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| functional and radiological outcome |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait parameters |
3 months |
| Quadricep function |
3 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
10/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
All the patients with tricompartmental arthritis of the knee who are candidate of total
knee arthroplasty (TKA) will be enrolled for the study. By this RCT, we aim to determine if Primary Total
knee arthroplasty with patellar resurfacing gives better results than total knee arthroplasty
without patellar resurfacing. We also intend to measure secondary Postoperative outcomes
like the knee functional assessment, pain assessment, gait assessment and Implant Position
in radiographs will be assessed. |