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CTRI Number  CTRI/2024/05/067065 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A clinical trial to study the effects of anterior cruciate ligament (ACL) injury on foot pressure 
Scientific Title of Study   Comparison of plantar pressure changes in patients with anterior cruciate ligament injury during static and dynamic activities between normal and affected limb 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  Karthikeyan K 
Designation  Junior resident, Department of Orthopaedics surgery 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Orthopaedics surgery PMRC block Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8825684020  
Fax    
Email  karthikeyanathan619@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. GOPISANKAR BALAJI. G  
Designation  Additional professor, Department of Orthopaedics surgery 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of orthopaedic surgery PMRC block Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9360330582  
Fax    
Email  drgopi9596@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karthikeyan K 
Designation  Junior resident, Department of Orthopaedics surgery 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Orthopaedic surgery PMRC block Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8825684020  
Fax    
Email  karthikeyanathan619@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, India 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. 
Type of Sponsor  Research institution and hospital 
 
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 Karthikeyan K  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Orthopaedic surgery, PMRC block, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY 		 8825684020

karthikeyanathan619@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Institute of Postgraduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M998||Other biomechanical lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  - Patients with knee instability secondary to ACL injury (MRI confirmed cases)
- Duration more than 1 month 
 
ExclusionCriteria 
Details  - History of other coexisting orthopaedic diseases such as osteoarthritis/past history of lower limb fractures
- Associated injury of collateral ligaments - grade 3, posterior cruciate ligament tear
- Bilateral ACL injuries
- Grade 3 menisceal injury
- Partial ACL tear 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plantar pressure - static
Plantar pressure - dynamic
Plantar pressure - climbing activity
Plantar pressure - descending activity
Plantar pressure - while performing Y balance test 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of center of pressure (% of COP)
Maximum amplitude of center of pressure (MACOP)
Center of pressure excursion index (CPEI) 		 At the time of measurement (One time only) 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   30/05/2024 
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 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 non-invasive technique using a device called pedobarometer is used to evaluate the altered biomechanics of lower limb during different phases of gait, such as climbing and descending activities, and assessment of impairment of maintaining dynamic balance using Y balance test is being done in this study. 
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