| CTRI Number |
CTRI/2025/06/088666 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Knee Function After Surgery: A Study on Knee Replacement for Arthritis Patients with deformed Knees |
|
Scientific Title of Study
|
Functional and radiological outcome of posteriorly stabilized knee arthroplasty in osteoarthritis of knee with varus deformity - a prospective 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 |
DR PRADEEP D |
| Designation |
Post Graduate Resident |
| Affiliation |
St. Peters medical college |
| Address |
opd 20, Dept. of orthopaedics
SPMCHRI - Hosur
Dr. MGR nagar hosur
635130
Dharmapuri
TAMIL NADU
635130
India |
| Phone |
9663552255 |
| Fax |
|
| Email |
drpd95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CB PATIL |
| Designation |
Professor |
| Affiliation |
St. Peters medical college |
| Address |
opd 20, Dept. of orthopaedics
SPMCHRI - Hosur
Dr. MGR nagar, hosur
635130
Dharmapuri
TAMIL NADU
635118
India |
| Phone |
9663552255 |
| Fax |
|
| Email |
patilortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP D |
| Designation |
Post Graduate Resident |
| Affiliation |
St. Peters medical college |
| Address |
opd 20, Dept. of orthopaedics
SPMCHRI - Hosur
Dr. MGR nagar, hosur
635130
Dharmapuri
TAMIL NADU
635118
India |
| Phone |
9663552255 |
| Fax |
|
| Email |
drpd95@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. peters medical college hospital and research institute - hosur |
|
|
Primary Sponsor
|
| Name |
SPMCHRI |
| Address |
St. peters medical college hospital and research institute,Dr. MGR nagar, Hosur 635130 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
5/224, Venkateshwara colony thally - 635118 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRADEEP D |
St. peters medical college hospital and research institute |
OPD 20, dept. of orthopaedics, st. peters medical college hospital and research institute, Dr. MGR nagar, hosur - 635130
Dharmapuri
TAMIL NADU |
9663552255
drpd95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age greater than 50 years.
Osteoarthritis of knee with grade 3 and above.
Osteoarthritis of knee with varus deformity. |
|
| ExclusionCriteria |
| Details |
Ipsilateral hip and ankle osteoarthritis.
Local and systemic infections.
Patients who are not fit for surgery.
Osteoarthritis with valgus deformity. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the outcome of posteriorly stabilized total knee arthroplasty with respect to
1. Postoperative functional results
2. Correction in alignment with respect to pre and postoperative radiological evaluation
|
Assessment will be carried out
1. preoperatively
2. postoperatively and on folloups on 0 month, 1st month, 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correction in alignment with respect to pre & postoperative radiological evaluation |
Assessment will be carried out
1. preoperatively
2. postoperatively & on folloups on 0 month, 1st month, 3rd month |
| Postoperative functional results |
Assessment will be carried out
1. preoperatively
2. postoperatively & on folloups on 0 month, 1st month, 3rd month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2025 |
| 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 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
|
Total knee arthroplasty has emerged as the gold standard for managing advanced knee osteoarthritis, restoring joint function and alleviating pain. Among various prosthetic designs, posteriorly stabilized knee arthroplasty has gained prominence due to its ability to compensate for deficient posterior cruciate ligament function thereby enhancing stability and improving postoperative outcomes. Evaluating the functional and radiological outcomes of this prosthetic design is crucial to optimizing surgical techniques and improving patient recovery. |