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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 105is 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  .


 

 
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