| CTRI Number |
CTRI/2026/04/107713 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Three Different Surgical Approaches used for Total Knee Replacement |
|
Scientific Title of Study
|
Comparison of Medial Parapatellar, Subvastus and Midvastus Approaches in Total Knee Replacement – A Randomized Control Trial |
| 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 Mandeep Mangla |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9855352121 |
| Fax |
|
| Email |
mandeepmangla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Landge |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007778654 |
| Fax |
|
| Email |
suhasvlandge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Landge |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
8007778654 |
| Fax |
|
| Email |
suhasvlandge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private 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 Mandeep Mangla |
Acharya Vinoba Bhave Rural Hospital |
Department of Orthopaedics, Ground floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9855352121
mandeepmangla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Medial parapatellar approach for total knee replacement |
Medial parapatellar approach will be followed for total knee replacement surgery. A straight incision will be made through the three layers of fascia over the quadriceps and the patella tendons. The quadriceps tendon will split along its fiber line just lateral to the vastus medialis insertion, and the synovia and deep aponeurosis will split medial to the patella. The infrapatellar bursa will be revealed when the patella tendon is released along its medial border to the level of the tibial tubercule. Laterally, the patellar will be displaced. Total duration of intervention is 12 months. |
| Intervention |
Midvastus Approach for Total Knee Replacement Surgery. |
Midvastus Approach will be followed for Total Knee Replacement Surgery. The deep incision is initiated by incising vertically through the medial parapatellar retinaculum at the level of and distance of 5 mm to the medial patellar facet. This incision is then extended proximally, sectioning an inferomedial cuff of VMO fibers up to a width of 1 cm. The incision is then acutely angled superiorly and medially, splitting the VMO fibers along the direction of travel, and extending no further than 5 cm proximal to the patellar margin. Total duration of intervention is 12 months. |
| Intervention |
Subvastus Approach for total knee replacement surgery |
Subvastus Approach will be followed for Total Knee Replacement Surgery. In line with the mid-line skin incision, the first layer of fascia will be cut. It will be cut somewhat medially at the patella level. The fascia layer I will be lifted from the vastus medialiss perimuscular fascia proximally and descend to the site of insertion. Using blunt finger dissection, the inferior margin of the vastus will be raised off the intermuscular septum and periosteum for about 10 cm proximal to the adductor tubercle. Total duration of intervention is 12 months. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. A severe Knee Osteoarthritis patient undergoing total knee replacement
2. Those who are willing to participate in study |
|
| ExclusionCriteria |
| Details |
1.Patient who will lose follow up
2. Patient with Rheumatoid Arthritis
3. Ankylosed knee for Total Knee Replacement Surgery
4. Severe Varus deformity of more then 20 degrees |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Superior approach of Total Knee Replacement among Medial Parapatellar, Subvastus and Midvastus Approaches |
Assessment will be done at 1 week, 6 weeks, 3,6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="2"
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
|
A
frequent public health issue that results in severe knee pain and functional
disability is osteoarthritis of the knee joint. Total knee replacement
(TKR) is a common orthopaedic procedure used to relieve pain and restore
function in patients with advanced knee joint disease. Three most
common used techniques are medial parapatellar
approach, medial subvastus approach and
medial midvastus approach. The aim of the study is to find out
superiority between medial sub-vastus, medial
mid-vastus and the medial parapatellar approach in the total knee
replacement technique. This study aims to find out superiority between
the medial subvastus, medial midvastus and the medial
parapatellar approach in the total knee replacement technique.
|