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CTRI Number  CTRI/2024/11/077216 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Treatment of upper tibia fracture using Nail. 
Scientific Title of Study   Outcome of Suprapatellar Nailing in Extra-articular proximal third tibial fractures. 
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 Krishna D Sambare 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept of Orthopedic Surgery Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  9284225941  
Fax    
Email  krishnasambare786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ratnakar Ambade 
Designation  Professor and head 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept of Orthopedic Surgery Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  9823033511  
Fax    
Email  drambade@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ratnakar Ambade 
Designation  Professor and head 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept of Orthopedic Surgery Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha


MAHARASHTRA
442107
India 
Phone  9823033511  
Fax    
Email  drambade@hotmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi Wardha India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi Wardha India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishna D Sambare  Shalinitai Meghe Superspeciality Center  Second floor Dept. of Orthopedic surgery, SMSC building Sawangi Meghe,442001
Wardha
MAHARASHTRA 
9284225941

krishnasambare786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Suprapatellar Nailing in Extra-articular proximal third Tibial fractures.  Cases of Extra-articular proximal third Tibial fractures will be treated with suprapatellar nailing. assessment will be done post operatively for functional and radiological outcome and follow up at 3, 6, 9 month will be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age more than 18 years.

Extra-articular proximal third tibial fracture Orthopedic Trauma Association type 41 A2 A3

Closed and Gustilo Anderson open type 1, II, IIIA 
 
ExclusionCriteria 
Details  Fractures involving the articular surface of tibia, Pathological Fractures, infective pathologies compound Gustilo and Anderson open type IIIB and C fractures to be excluded.

Extra-articular Proximal third tibial fractures associated with other lower limb ipsilateral or contralateral fractures to be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Radiological and functional outcome of suprapatellar nailing in extra-articular proximal third tibial fracture will be evaluated.   Assessment will be done at the end of 1 month, 3 month, 6 month, and 9 month. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   01/01/2025 
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="2"
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  

Fracture of tibia are one of the most common long bone fracture in general population now a days due to increasing trend in the high velocity and high energy trauma mechanisms associated with road traffic accidents and other traumatic injuries. They constitute about 17% of all lower limb fractures. Extraarticular proximal-third fractures of Tibia account for 5% to 11% of all tibial shaft fractures Proximal tibia fracture are frequently associated with high energy trauma mechanisms. For diaphyseal factures of tibia intramedullary nailing is considered as the gold standard. standard tibia nailing are done via infra and parapatellar approaches , suprapatellar tibia nailing is the recent advance in the surgical technique for treatment of tibia fracture, as it have better outcome according to previously conducted studies. For tibia nailing can be considered superior to other conventional approaches in terms of lesser post op knee pain, load sharing, preservation of Extraosseous blood supply, very minimal soft tissue dissection thereby reducing the risk of postoperative complications. shorter fluoroscopy time , less vas score, better sagittal plane alignment , lower incidence of angular malalignment , better functional recovery, and improved fracture reduction. with no increased risk of post operative complication. This study aims to assess radiological and functional outcome of suprapatellar nailing in Extra articular proximal third tibial fracture.

 
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