| CTRI Number |
CTRI/2026/03/106397 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of kneecap position and its effect on knee function after knee replacement surgery |
|
Scientific Title of Study
|
Evaluation of patellar height indices and their correlation with functional outcomes following primary total knee arthroplasty |
| 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 Virender Kumar |
| Designation |
Associate Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9555555665 |
| Fax |
|
| Email |
drvirortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aryan Chauhan |
| Designation |
MS Post Graduation Student |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9050880241 |
| Fax |
|
| Email |
aryanchauhan9914@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aryan Chauhan |
| Designation |
MS Post Graduation Student |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
HARYANA
124001
India |
| Phone |
9050880241 |
| Fax |
|
| Email |
aryanchauhan9914@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma, PGIMS, Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
Pt B D Sharma, PGIMS, Rohtak, Haryana 124001 |
| 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 Aryan Chauhan |
Pt B D Sharma PGIMS |
Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA |
9050880241
aryanchauhan9914@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt B D Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary osteoarthritis of the knee who will undergo primary TKA |
|
| ExclusionCriteria |
| Details |
Previous knee surgery or having knee scar, patient having impaired knee sensation from any cause before TKA, Secondary OA knee, Revision TKA, Difficulty in mobility due to foot ankle and hip disorders, patient requiring hinged prosthesis, leg length discrepancy, neurological disorder of lower limb, Inflammatory arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate different patellar height indices and correlate them with functional outcomes scores in patients undergoing TKA |
1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/03/2026 |
| 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 Yet Recruiting |
| 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
|
This prospective cohort study will be conducted in the Department of Orthopaedics at Pt. B.D. Sharma PGIMS, Rohtak, to evaluate patellar height indices and their correlation with functional outcomes following primary total knee arthroplasty (TKA). Patients with primary osteoarthritis of the knee undergoing TKA will be included. Patellar height indices such as Insall-Salvati, Modified Insall-Salvati, and Caton-Deschamps indices will be measured on radiographs pre- and post-operatively. Patients will be followed at 1, 3, and 6 months after surgery, and functional outcomes will be assessed using Knee Society Score (KSS), WOMAC, and KOOS-JR scores along with pain assessment. The study aims to determine the relationship between patellar height changes and postoperative functional outcomes after TKA. |