| 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
|
|
|
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
|
|
|
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. 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. |