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CTRI Number  CTRI/2024/02/062250 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of functional outcome of distal end radius fractures managed with external fixation methods 
Scientific Title of Study   Evaluation of functional outcome of distal end radius fractures managed with external fixation methods: 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  Dr Patel Nipun 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College 
Address  Department of Orthopaedics Rohilkhand Medical College and Hospital Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8460863830  
Fax    
Email  patelnipun7777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lekhraj Verma 
Designation  Professor 
Affiliation  Rohilkhand Medical College 
Address  Department of Orthopaedics Rohilkhand Medical College and Hospital Bareilly UP

Bareilly
UTTAR PRADESH
243006
India 
Phone  9418077080  
Fax    
Email  vermalekhraj@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Praveen Garg 
Designation  Professor 
Affiliation  Rohilkhand Medical College 
Address  Department of Orthopaedics Rohilkhand Medical College and Hospital Bareilly UP

Bareilly
UTTAR PRADESH
243006
India 
Phone  8979225655  
Fax    
Email  drpraveengarg.ortho@gmail.com  
 
Source of Monetary or Material Support  
Department of orthopedics Rohilkhand medical college and hospital Bareilly  
 
Primary Sponsor  
Name  Rohilkhand medical college 
Address  department of orthopaedics rohilkhand medical college and hospital bareilly up 
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 
Dr Lekhraj Verma  Rohilkhand Medical College   Department of Orthopaedics OT Complex Rohilkhand Medical College and Hospital Bareilly
Bareilly
UTTAR PRADESH 
9418077080

vermalekhraj@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,RMCH,Bareilly, U.P.  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 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age more than 18 years

AO classification type A (extraarticular fracture), type B ( partial intra-articular ), and type C ( complete intraarticular )

Closed as well as open fractures

Those who ready to give informed written consent
 
 
ExclusionCriteria 
Details  Pathology of wrist joint or malunited distal radius fracture
Those who will be maked unfit for the procedure after pre- anaesthetic check up
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the functional outcome of distal end radius fractures managed with external fixation.

 
1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the radiological outcome of distal end radius fractures managed with external fixation.  1 year 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   12/02/2024 
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  

Fractures of distal end radius are most common fractures of upper limb, consisting more than 17.5% of all fractures. Distal radial fractures have a bimodal type of age distribution both in younger and elderly population. Women aged 60 and older are most likely to suffer from fractures of distal radius.

A lower amount of strong cortical bone and higher amount of weaker cancellous bone are main reasons for the metaphyseal widening of the distal radius and predisposed it to fractures. The major risk factors are osteoporosis and a tendency to fall. Therefore, a fracture of the distal radius is typically the result of a fall on the outstretched arm in a post menopausal woman.

Until about 60 years ago, it was general conception that most distal radial fractures could be treated conservatively. Only recently, it was clinically proved that surgical correction of intra-articular step-off and radial shortening had improved patient outcome. These issues are not for elderly people who have low functional and physical demand. In general anatomic reduction should be followed in younger and high-demand elderly patients to initiate early mobilization with extra-articular or intra-articular fractures. Surgical management may also required for low-demand elders with severely displaced intraarticular fracture or median nerve compression but the prime focus for these patients should be on joint movement.

 Plating, intramedullary fixation, external fixation or pinning are commonly used for irreducible extra-articular fractures, intra articular fractures and for demanding patients who require early mobilization. Close reduction and cast immobilization which are the principal mode of management of distal radius fractures but it may lead to fracture malunion and subluxation /dislocation of distal radio ulnar joint, resulting in poor outcomefunctionally, radiographic and cosmetically results. The residual worse deformity of wrist adversely affected wrist motion and hand function, thereby interfering with the mechanical advantage of extrinsic hand musculatureIt also cause pain, limitation of forearm motion, and decreased grip strength as a result of arthrosis of the radiocarpal and distal radioulnar joints.

The external fixator used commonly in the treatment of distal radius fractures and also for various injuries about the wrist. The addition of K-wires to an external fixation has been proven to have increased rigidity. Comminuted fracture patterns often difficult to reduce and maintain the reduction over time. So, additional K-wires are providing additional stability to the fracture site.

Now, the trend is towards open reduction and internal fixation (ORIF) and away from external fixation. However, we believe that, external fixation is a valuable tool for treatment of fracture and through this review we will show its effectiveness.

Our study deals with the radiological assessment of the post-operative fixation of the fractures, done using X-rays. Standard anteroposterior and lateral views taken to assess fracture pattern and to assess the parameters like palmar tilt, radial height, radial inclination, displacement and involvement of radio carpal and distal radio-ulnar joints.

 
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