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CTRI Number  CTRI/2020/05/025264 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 20/05/2020
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   A Study Comparing The Outcome of Metallic Plate Fixation Versus Wire Fixation in Treating Fractures of The Wrist Joint 
Scientific Title of Study   Volar Plate Versus K-Wire Fixation in Intra-Articular Fracture of Distal Radius 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAURAV CHATTERJEE 
Designation  POST GRADUATE 
Affiliation  VIMSAR, BURLA 
Address  Department of Orthopaedics, VSS Institute of Medical Sciences and Research Ayurvihar,Burla,768017

Sambalpur
ORISSA
768017
India 
Phone  8895536087  
Fax  06632430767  
Email  gaurabapu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  BRAJA SUNDAR SAHOO 
Designation  ASSOCIATE PROFESSOR 
Affiliation  VIMSAR, BURLA 
Address  Department of Orthopaedics, VSS Institute of Medical Sciences and Research Ayurvihar,Burla

Sambalpur
ORISSA
768017
India 
Phone  9437108739  
Fax  06632430767  
Email  drbssahoo@gmail.com  
 
Details of Contact Person
Public Query  
Name  GAURAV CHATTERJEE 
Designation  POST GRADUATE 
Affiliation  VIMSAR,BURLA 
Address  Department of Orthopaedics, VSS Institute of Medical Sciences and Research Ayurvihar,Burla,768017

Sambalpur
ORISSA
768017
India 
Phone  8895536087  
Fax  06632430767  
Email  gaurabapu@gmail.com  
 
Source of Monetary or Material Support  
VSS INSTITUTE OF Medical Sciences and Research,Ayurvihar,Burla,768017 
 
Primary Sponsor  
Name  GAURAV CHATTERJEE 
Address  VSS INSTITUTE OF Medical Sciences and Research,Ayurvihar,Burla,768017 
Type of Sponsor  Other [Principal investigator] 
 
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 
GAURAV CHATTERJEE  VSS INSTITUTE OF Medical Sciences and Research  Department of orthopaedics
Sambalpur
ORISSA 		 8895536087

gaurabapu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VIREC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S525||Fracture of lower end of radius,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  OPEN REDUCTION AND INTERNAL FIXATION WITH VOLAR PLATE  Will be done by volar Henry’s approach. Reduction and internal fixation with LIMITED CONTACT PLATE will be done. Immobilization with volar wrist support for 15 days will be given. Functional rehabilitation will be done 15 days after surgery.  
Intervention  Pin and plaster   Closed reduction under C-arm image intensifier. 2-3 k-wires will be introduced from the radial styloid, 1 k-wire for stabilization of distal radio-ulnar joint. Brachio-metacarpal plaster cast will be given Wires and cast removal after 4 weeks followed by functional re-habilitation will be done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Articular fractures: AO type B & type C1-2
2.Age >18years i.e. skeletally mature
3.Isolated lesions
4.>15 degree displacement on lateral plane
5.>5mm radial shortening on frontal plane
6.Minimum of 2mm of either gap or step off
 
 
ExclusionCriteria 
Details  1.Open fractures and neuro-vascular lesions
2.Ipsilateral upper extremity associated lesions
3.Previous history of fracture of the wrist
4.Patients with congenital anomaly of the wrist
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.MAYO wrist score
2.DASH score
 		 3 MONTHS
6 MONTHS
12 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Age {young/old}
2.Sex {male/female}
3.Mechanism of trauma {fall/motor-vehicular accident/occupational accident}
4.Side involved {dominant/ non-dominan
5.Operative time{in mins}
6.Blood loss{ in ml}
7.Incidence of infection{ in percentage}
8.Number of C-arm exposure{ number of shots}
9.Duration of hospital stay{ in days}
 		 3 MONTHS
6 MONTHS
12 MONTHS 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 1 
Date of First Enrollment (India)   25/05/2020 
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)?  

Brief Summary   OBJECTIVE:

To compare the two procedures: percutaneous k-wire fixation and open reduction internal fixation with volar plating in treatment of distal radius intra-articular fractures.

HYPOTHESIS:

Better functional outcome is achieved with open reduction and volar plating.

 

 
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