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CTRI Number  CTRI/2021/03/032328 [Registered on: 26/03/2021] Trial Registered Prospectively
Last Modified On: 26/03/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Bony realignment with ligament reconstruction for treating knee instability 
Scientific Title of Study   Functional Outcome Of Medial Patellofemoral Ligament Reconstruction With Tibial Tuberosity Transfer For Patellar Instability Associated With High Grade Trochlear Dysplasia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shankar S 
Designation  Assistant Professor 
Affiliation  Mosc Medical College 
Address  Institute of advanced Orthopaedics, MOSC Medical College, Kolenchery, Ernakulam, Kerala, India

Ernakulam
KERALA
682311
India 
Phone  9037463273  
Fax    
Email  sanu.shankar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Shankar S 
Designation  Assistant Professor 
Affiliation  Mosc Medical College 
Address  Institute of advanced Orthopaedics, MOSC Medical College, Kolenchery, Ernakulam, Kerala, India

Ernakulam
KERALA
682311
India 
Phone  9037463273  
Fax    
Email  sanu.shankar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Shankar S 
Designation  Assistant Professor 
Affiliation  Mosc Medical College 
Address  Institute of advanced Orthopaedics, MOSC Medical College, Kolenchery, Ernakulam, Kerala, India

Ernakulam
KERALA
682311
India 
Phone  9037463273  
Fax    
Email  sanu.shankar@yahoo.co.in  
 
Source of Monetary or Material Support  
MOSC Medical College  
 
Primary Sponsor  
Name  Mosc Medical College 
Address  Medical College Road Kolenchery P O Ernakulam - 682311 Kerala 
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 
Shankar S  Mosc Medical College  Institute of Advanced Orthopaedics, OPD NO 5, Kolenchery Medical College Junction, Kochi-Madurai-Tondi Point Rd, Kolenchery, Kerala 682311, India
Ernakulam
KERALA 		 9037463273

sanu.shankar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M20-M25||Other joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  recurrent lateral patellar dislocation
high grade trochlear dysplasia (types B, C, D in Dejour classification)
TT-TG distance >15 mm 
 
ExclusionCriteria 
Details  Skeletal immaturity
Outerbridge 3 or 4 arthritis of patellar cartilage 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in functional scores
1.Kujala
2.Lysholm
3.International Knee Documentation Committee (IKDC)  		 2 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
COMPLICATION RATE
 		 2 YEARS 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   31/03/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanu.shankar@yahoo.co.in].

  6. For how long will this data be available start date provided 13-03-2022 and end date provided 31-03-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Patellar instability is relatively uncommon condition affecting knee function in young individuals, with an active lifestyle and leads to early arthritis if untreated. 

The aim of this study is to observe the functional outcome of medial patellofemoral ligament reconstruction with modified Fulkerson osteotomy in 26 patients with recurrent dislocation of patella associated with high-grade trochlear dysplasia. Patient outcomes will be measured with Kujala, Lysholm & International Knee Documentation Committee (IKDC) subjective knee evaluation form. Radiological outcome was measured by MRI at 6 months after surgery.

We hypothesized that this procedure would anatomically treat patellar instability by realigning the extensor mechanism, achieving good patellar stability and knee function.


 
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