FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097391 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Recovery and Shoulder movement after two different plate fixation methods for collar bone fractures 
Scientific Title of Study   Analysis of Functional and Radiological outcomes between Single vs Dual Plating in Midshaft Clavicular fractures - A Randomised Controlled 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  Bhagwat Tewari 
Designation  Junior Resident, MS Orthopaedics 
Affiliation  SRM medical college hospital and research centre 
Address  Department of Orthopaedics, srm medical college hospital and research institute, srm university, Chennai, Tamil Nadu 603203 , India

Chennai
TAMIL NADU
603203
India 
Phone  7082837668  
Fax    
Email  bhagwattewari15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Anand B 
Designation  Head of Department of Orthopaedics 
Affiliation  SRM medical college hospital and research centre 
Address  HOD office ,Department of Orthopaedics, SRM medical college and research institute, srm university, Chennai, Tamil Nadu 603203 , India

Chennai
TAMIL NADU
603203
India 
Phone  9790963468  
Fax    
Email  vijayanb@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Bhagwat Tewari 
Designation  Junior Resident, MS Orthopaedics 
Affiliation  SRM medical college hospital and research centre 
Address  Department of Orthopaedics, srm medical college hospital and research institute, srm university, Chennai, Tamil Nadu 603203 , India

Chennai
TAMIL NADU
603203
India 
Phone  7082837668  
Fax    
Email  bhagwattewari15@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Bhagwat Tewari 
Address  6/6 J medical Campus Rohtak Haryana 124001 
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 
Dr Bhagwat Tewari  SRM medical college hospital and research centre  Department of orthopaedics, 2nd floor, srm medical college building, kattankulathur 603203 Tamil Nadu
Chennai
TAMIL NADU 		 7082837668

bhagwattewari15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM medical college hospital and research centre, SRM university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S420||Fracture of clavicle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ORIF with dual plating  The surgical approach and fracture reduction are similar to the single-plate technique. After achieving reduction, two low-profile plates (typically one superior and one anteroinferior) are applied and secured with screws to provide enhanced multidirectional stability. Final fixation is checked and the wound is closed in layers. Total operative duration is approximately 75–110 minutes, depending on fracture comminution. 
Intervention  ORIF with single plating  Open reduction and internal fixation is performed through a standard superior or anteroinferior approach. After exposure and anatomical reduction of the fracture, a single precontoured locking compression plate is positioned on the superior or anteroinferior surface of the clavicle and fixed with screws on both sides of the fracture. Stability is confirmed and the wound is closed in layers. Total operative duration is approximately 60–90 minutes, depending on fracture pattern. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All adult patients
Closed Midshaft clavicular fractures
 
 
ExclusionCriteria 
Details  pathologic fractures
previous surgery on the same clavicle
other ipsilateral fractures
skeletally immature individuals
open fractures
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
FUNCTIONAL ASSESSMENT

1) QUICK DASH SCORE
2) ASES (AMERICAN SHOULDER AND ELBOW SURGEON SCORE)



RADIOLOGICAL UNION of 4 cortices
 		 2 weeks, 4 weeks, 3 months and 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/12/2025 
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="9"
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   Midshaft clavicle fractures form about 10% of all fractures. Open reduction and internal fixation (ORIF) using plates provide better union and functional outcomes than non-operative management but are associated with complications like implant prominence and irritation. Dual mini-fragment plating has been proposed to improve fixation rigidity while minimizing implant-related issues, though comparative data are limited. 
Close