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CTRI Number  CTRI/2025/10/096444 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study of Ankle Movement in Patients with Tibia Fracture 
Scientific Title of Study   Analysis of Ankle Range of Motion in patients with Tibial Plateau Fractures: A Cross-Sectional 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  Payel Bhattacharjee 
Designation  Postgraduate Student 
Affiliation   
Address  3rd floor, Ramaiah College of Physiotherapy, M. S. Ramaiah Nagara, MSRIT Post, Bangalore – 560054
3rd floor, Ramaiah College of Physiotherapy, M. S. Ramaiah Nagara, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA
560054
India 
Phone  8697017763  
Fax    
Email  bhattacharjeepayel03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Soni Srikantaiah  
Designation  Professor 
Affiliation   
Address  3rd floor, Ramaiah College of Physiotherapy, M. S. Ramaiah Nagara, MSRIT Post, Bangalore-560054
3rd floor, Ramaiah College of Physiotherapy, M. S. Ramaiah Nagara, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA
560054
India 
Phone  9740390880  
Fax    
Email  soni.rcp@msruas.ac.in  
 
Details of Contact Person
Public Query
 
Name  Soni Srikantaiah 
Designation  Professor 
Affiliation   
Address  3rd floor Ramaiah College Of Physiotherapy, M. S. Ramaiah Nagara, MSRIT Post, Bangalore-560054
3rd floor Ramaiah College Of Physiotherapy, M. S. Ramaiah Nagara, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA
560054
India 
Phone  9740390880  
Fax    
Email  soni.rcp@msruas.ac.in  
 
Source of Monetary or Material Support  
M.S Ramaiah University of Applied Sciences, M.S Ramaiah Nagar, MSRIT Post, Bangalore 560054 
 
Primary Sponsor  
Name  Payel Bhattacharjee 
Address  3rd floor, Ramaiah College of Physiotherapy, M.S.R. Nagar, MSRIT Post, Bangalore 560054 
Type of Sponsor  Other [self] 
 
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 
Payel Bhattacharjee  M.S Ramaiah Medical College and Hospitals  3rd floor, Ramaiah College Of Physiotherapy, M. S. Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA 
8697017763

bhattacharjeepayel03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M.S Ramaiah Medical College and Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patients with tibial plateau fractures post-operative 3 months 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Unilateral tibial plateau fracture
Age 20 to 50 years
BMI within normal range 18 to 24 kg per meter square
more than 12 weeks postoperative with full weight bearing clearance
Type of surgery like open reduction internal fixation, minimally invasive osteosynthesis, and closed reduction internal fixation
Schatzker classification type 1 to 6 patients who have undergone surgery
 
 
ExclusionCriteria 
Details  Pre existing knee and ankle pathologies, e.g., knee osteoarthritis, ligament injuries, etc.
Neurological deficits affecting lower limb function
Patients undergoing rehabilitation
Polytrauma patients
Obese individuals having a BMI more than 30 kg per meter square
Elderly patients above 60 years with degenerative changes in lower limb
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate ankle ROM in individuals post-tibial plateau fracture surgery after the commencement of full weight-bearing. It will be a one-time assessment at or post 12 weeks after commencement of full weight bearing without any use of walking aids.  post 12 weeks (after commencement of full weight bearing) 
 
Secondary Outcome  
Outcome  TimePoints 
To examine spatiotemporal parameters of gait post tibial plateau fracture surgery after the commencement of full weight bearing. It will be a one-time assessment at or post 12 weeks after commencement of full weight bearing without any use of walking aids.  post 12 weeks (after commencement of full weight bearing) 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   24/11/2025 
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="1"
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  

Tibial plateau fractures are fractures of the proximal aspect of the tibia involving the articular surface, subchondral bone, and metaphysis. These fractures affect the primary weight-bearing joint, i.e., the knee joint. This type of fracture most commonly occurs due to high-energy trauma (e.g., road traffic accident, fall from height) in young adults and due to low-energy trauma (e.g., falls, twisting injuries during simple activities like turning) in the elderly.  The incidence of tibial plateau fractures is 10.3 per 100,000 people per year and constitutes about 1-2% of all fractures in our nation. These fractures are classified based on the Schatzker classification. This classification is often used to plan the type of surgical procedure to restore joint congruity and alignment.  Depending on the type of approach taken during the surgical procedure, the muscles that are commonly retracted and cut are the tibialis anterior, peroneal, gastrocnemius, iliotibial band, semimembranosus, and quadriceps. Since the muscles are retracted and cut, it could possibly lead to arthrogenic inhibition of the muscles connecting both knee and ankle, altering ankle function.  According to the kinetic chain theory, there is a biomechanical link between the proximal and distal tibiofibular joints.  Due to the biomechanical interdependence of the ankle and knee joints, restricted ankle dorsiflexion may result in modified knee kinematics and compensatory mechanisms that put more strain on the knee joint. This interaction is essential for functional tasks like walking and squatting. This could be a reason as to why there can be alterations in ankle biomechanics with the tibial plateau affecting the kinetic chain, including the ankle, knee, and overall lower limb.

Although the tibial plateau fracture affects the knee, studies show gait deviation and altered joint loading persist even after one-year post-surgical fixation, leading to compensatory stress at the ankle. The literature lacks objective quantification on how the ankle and, in turn, the gait are affected.  The ankle is a crucial joint for not only weight-bearing activities but also balance and proprioception. Given that this type of fracture follows a prolonged non-weight-bearing phase, ankle joint mobility can indirectly be compromised.  The ankle complex is often overlooked because the primary target is the knee from a targeted rehabilitation point of view.  This can contribute to altered gait, instability, and other systemic changes, which can lead to poor functional outcomes and reduce the quality of living.  Since most literature focuses on knee recovery after tibial plateau fractures, the ankle joint is often overlooked despite its biomechanical link through the kinetic chain. This study will encourage a more holistic approach to rehabilitation.

 Hence, there lies a need to assess and analyze the range of motion of the ankle in patients with tibial plateau fracture after they commence full weight bearing. 
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