| CTRI Number |
CTRI/2025/04/085449 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of posterior tibial slope on range of motion of knee after stabilizing the posterior cruciate in total knee arthroplasty |
|
Scientific Title of Study
|
Effect of posterior tibial slope on range of motion after posterior cruciate stabilizing 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 |
Shashank yadav |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of orthopaedics, jawaharlal nehru medical college,sawangi meghe, Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
8006106570 |
| Fax |
|
| Email |
shashankyadav0029@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of orthopaedics, jawaharlal nehru medical college,sawangi meghe, Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
09823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ratnakar Ambade |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Medical Science and Research |
| Address |
Department of orthopaedics, jawaharlal nehru medical college,sawangi meghe, Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
09823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha Maharashtra 442107 India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Maharashtra 442107 India
|
| 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 Shashank Yadav |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
Datta meghe institute of higher education and research, Department of Orthopaedic, Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Sawangi(Meghe) 442107
Wardha
MAHARASHTRA Wardha MAHARASHTRA |
8006106570
shashankyadav0029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) People undergoing posterior stabilizing primary knee arthroplasty
2) Age more than 50 years
3) Patients giving informed consent |
|
| ExclusionCriteria |
| Details |
1) People diagnosed with rheumatoid arthritis
2) Previous open surgery on affected knee joint
3) Arthritis, such as inflammatory or post traumatic arthritis
4) Severe flexion contracture over 20 degrees |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate posterior tibial slope in posterior stabilizing total knee arthroplasty
2) To analyze range of motion after posterior stabilizing total knee arthroplasty
3) To study effect of posterior tibial slope |
Pre operative, 4 weeks, 12 weeks and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/05/2025 |
| 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 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
|
The posterior
inclination of the tibial plateau, sometimes known as the posterior tibial
slope, is an significant characteristic in patients having complete knee
replacements as it influences the knee joint’s kinematics. The American Knee
Society accepted the posterior tibial slope in recognition of its significance
for the Studies examining the sagittal alignment of the tibial component in
patients treated with knee arthroplasty frequently describe the results of
radiographic examination of knee arthroplasty. One goal of total knee arthroplasty is to
maximize range of motion(ROM) after surgery. Improved
function and greater patient satisfaction are linked to increased
mobility. Several Studies have shown that patients need an average of 670
flexion during the swing phase of their stride, 830 flexion for
stair climbing, 900 flexion for stair descent, and 930 to
get up from their seat. For kneeling and squatting during daily activities and
religious rituals, flexion greater than 1050 is required in several
Eastern Hemisphere nations. Among these
include the state of the soft tissues(flexion contracture, for example, or
severe tibio femoral (varus or valgus), preoperative range of motion, surgical
method, selected surgical approach, prosthetic shape and size, posterior
cruciate ligament preservation or replacement, joint line height, prosthetic
location ,and anterior posterior tibial cut angle (tibial slope). According to
computer modeling, postoperative range of motion might be increased by raising
the posterior tibial tilt. But there have been no in vivo studies that show how
the proximal tibial cut’s slope affects range of motion following total knee
replacement studies
reviewing The
Effect of Posterior Tibial Slope on Range of Motion After Total Knee Arthroplasty have been done but but results have been mixed, and question remain There is
very little research available convincingly demonstrate, thus more
studies are required to be conducted for further evidence
.
|