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CTRI Number  CTRI/2021/02/031279 [Registered on: 15/02/2021] Trial Registered Prospectively
Last Modified On: 11/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of Functional results obtained after Surgical treatment for Wrist Fracture treated by Two different types of Plates 
Scientific Title of Study   A Comparative Study Of Functional Outcome Of Intra Articular Fracture Distal End Radius Treated With Variable Angle Locking Compression Plate Versus Fixed Angle Locking Compression Plate 
Trial Acronym  VA -LCP v/s FA-LCP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDeepak Kumar 
Designation  Junior Resident  
Affiliation  AIIMS , RAIPUR 
Address  Department of Orthopaedics, Ground Floor,Room no 3, D Block, AIIMS Raipur, Tatibandh Road, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9465503789  
Fax    
Email  deepak.krgg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harshal Sakale  
Designation  Associate Professor 
Affiliation  AIIMS, RAIPUR 
Address  Department of Orthopaedics, AIIMS, RAIPUR, CG

Raipur
CHHATTISGARH
492099
India 
Phone  8518881731  
Fax    
Email  harshal2082@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Kumar 
Designation  Junior Resident  
Affiliation  MBBS, PG JUNIOR RESIDENT (MS ORTHO) 
Address  Department of ORTHOPAEDICS,Room no. 3, Ground Floor, D block, AIIMS Raipur, Tatibandh Road, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9465503789  
Fax    
Email  deepak.krgg@gmail.com  
 
Source of Monetary or Material Support  
AIIMS , RAIPUR 
 
Primary Sponsor  
Name  Aiims Raipur 
Address  Tatibandh Road, Raipur 
Type of Sponsor  Research institution 
 
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 
DrDEEPAK KUMAR  AIIMS RAIPUR  Room no 3, DEPARTMENT OF ORTHOPAEDICS,D-BLOCK, GROUND FLOOR,AIIMS RAIPUR,TATIBANDH ROAD
Raipur
CHHATTISGARH 
9465503789

deepak.krgg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Open Reduction and Internal Fixation with Volar Locking Compression Plate  All the patients with Intra articular fracture distal end radius (AO Classification AO 23.B1 , AO 23.B2 , AO 23.B3, AO 23.C1,AO 23.C2, AO23. C3 ) , fulfilling the inclusion criteria of the study will be the subjects of the study.They will be evaluated both clinically and radiologically for suitability of the surgery and evaluation of the fracture. All the patients willing to participate in the study , after they give consent , will be assigned either of the 2 groups randomly through Random Number Table method. All the patients will be treated with Modified Henry’s Volar approach.All the operated Patients will be followed for a period of 6 months, with one evaluation at 15 days post–surgery for suture removal and to check wound site and monthly for first 3 months and then at 6 months post-surgery to evaluate Range of motion at wrist by Mayo wrist score and Radiological outcome with Sarmiento modification of Lindstrom’s criteria.Any complication during procedure will be documented for each patient of both groups and treated according to the standard protocol.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Radiological findings confirming intra articular fracture of Distal End Radius according to AO classification ( Type 23.B1 to 23.C3)
2.Patient who are willing for surgery
3.Age group more than 18 years
 
 
ExclusionCriteria 
Details  1.Patients with pathological fractures
2.Open fractures Gustilo and Anderson type II or type III
3.Fracture with neuro- vascular injury
4.Contralateral injury to wrist and carpals
5.Ipsilateral fracture of shoulder and elbow
6.Pregnant woman
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional and Radiological outcome using fixed and variable angle locking compression plate  Patients will be followed for a period of 6 months, with one evaluation at 15 days post–surgery for suture removal and to check wound site and monthly for first 3 months and then at 6 months post-surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
complications and other problems related to study  6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/02/2021 
Date of Study Completion (India) 20/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/12/2021 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Distal radius fractures are the most common fractures of upper limb presenting in the  emergency, compromising of more than 16% of all the fractures. Distal radial fractures have a bimodal type of age distribution with High-energy trauma contributing in younger and low energy trauma in Elderly population. Females are more liable to distal radius fractures when compared with males mainly because of more severe osteoporosis and a higher liability of elderly women to fall as compared to the age matched men.Consequently, a fracture of the distal  radius is typically the result of a fall on an outstretched hand in a post menopausal woman, where a functionally active person suffers a trauma on an osteoporotic bone. About 60 years ago, most distal radial fractures were treated conservatively with satisfactory results. Recently, it has been clinically proved that intra-articular step-off and radial shortening corrected by surgery have improved patient outcome.In general, anatomic reduction and stable fixation should be pursued in younger and high-demand elderly patients to initiate early mobilization. Undisplaced or reducible but stable extra and intra-articular fractures can also be treated with casting. Extra articular fractures that are irreducible, intra-articular fractures and fractures for demanding patients who require early mobilization, are commonly treated with plating (more often with Volar plating), intra medullary fixation, external fixation or pinning. Dorsal plating is rarely used due to complications like  extensor tendon rupture, tendinosis and  volar collapse.Close reduction and cast immobilization has been the principal mode of  management of distal radius fractures but it often lead  to  fracture malunion and subluxation/ dislocation of distal radio-ulnar joint, hence resulting in poor functional, radiographic and cosmetic  result.The residual deformity of wrist adversely affected wrist motion and hand function, there by interfering with the mechanical advantage of the extrinsic hand musculature.It also causes pain, limitation of forearm motion, and decreased grip strength as a result of arthrosis of the radiocarpal and distal radioulnar joints. Open reduction and volar plating was designed to ensure more consistent correction of the displacement, maintenance of reduction and to initiate early range of movement exercises. The purpose of  this study is to compare  functional and radiological outcomes of  variable angle locking compression to fixation strategies with fixed  angle volar locking compression plates.

 
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