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CTRI Number  CTRI/2025/01/079405 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Single center prospective longitudinal descriptive study 
Study Design  Other 
Public Title of Study   Results of femoral neck system surgery for fracture neck of femur 
Scientific Title of Study   Clinical and radiological outcome of internal fixation of fracture neck of femur in adults using femoral neck system 
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 Soham Sadekar 
Designation  Junior resident  
Affiliation  Kasturba Hospital, MAHE, Manipal  
Address  Room no.4, Department of Orthopaedics, Kasturba hospital, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9892786911  
Fax    
Email  sadekarsoham898@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raghuraj Kundangar 
Designation  Associate professor 
Affiliation  Kasturba Hospital, MAHE, Manipal  
Address  Room no.4, Department of Orthopaedics, Kasturba hospital, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9880884933  
Fax    
Email  raghuraj.sk@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Soham Sadekar 
Designation  Junior resident  
Affiliation  Kasturba Hospital, MAHE, Manipal  
Address  Room no.4, Department of Orthopaedics, Kasturba hospital, Manipal, Karnataka 576104


KARNATAKA
576104
India 
Phone  9892786911  
Fax    
Email  sadekarsoham898@gmail.com  
 
Source of Monetary or Material Support  
Kasturba hospital, MAHE, Manipal, Udupi, Karnataka , India 576104 
 
Primary Sponsor  
Name  Dr Soham Sadekar 
Address  Room no. 4, Department of Orthopaedics, Kasturba hospital, MAHE, Manipal, Karnataka 576104 
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 Soham Sadekar  Kasturba Hospital, mahe, Manipal   Room no. 4, Department of Orthopaedics, Kasturba hospital , Manipal, Karnataka 576104
Udupi
KARNATAKA 
9892786911

sadekarsoham898@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult patients [aged above 18 years] diagnosed with fracture neck of femur and treated with internal fixation by femoral neck system at Kasturba hospital, Manipal 
 
ExclusionCriteria 
Details  -Patients with other associated lower limb/hip fractures in ipsilateral or contralateral limb
-Patients with diagnosed psychiatric disorders or cognitive dysfunction unable to rpovide accurate history/complains
-Patients with pathological fractures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Fracture union rate(RUSH)
-time to union
-Loss of fixation
-non-unions
-development of Avascular necrosis
-Harris hip score
-Visual analogue scale. 
-Immediate post-op
-6 weeks
-3 months
-6 months
-9 months
-1 year 
 
Secondary Outcome  
Outcome  TimePoints 
-Time to union
-Loss of fixation
-non-unions
-development of Avascular necrosis 
-Immediate post op
-6 weeks
-3 months
-6 months
-9 months
-1 year 
 
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   N/A 
Date of First Enrollment (India)   29/01/2025 
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="1"
Months="3"
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  
  1. Purpose of this study is to assess the results of Femoral neck system in treatment of fracture neck of femur. This study will be conducted from December 2024 to April 2026 and will recruit 50 or more participants. The study will involve analyzing the results of Femoral neck system in fracture neck of femur by observing the progress in patients treated with the same. This will include detailed history taking, clinical examination, study of X-rays of the participants. Femoral neck system is standard of care in fracture neck of femur. All adult patientswithFemur neck fractures planned for Internal fixation with Femoral neck system will be included in this study. Pre-operative clinical assessment will include Recording Harris hip score, Charite mobility index and pain as per visual analogue scale for all patients at presentation. Radiological assessment will include Recording femur neck length and femur neck shaft angles from X-rays at presentation. Post-operative assessment will be done Immediate post-op and at 6 weeks, 3 months, 6 months, 9 months and 1 year follow-ups [The follow up durations are routinely followed as standard of care and not done for purpose of study] which will include Recording Harris hip scores, Charite mobility index and pain. Radiological assessment will include noting Fracture union [RUSH), Non-union, loss of fixation, Avascular necrosis of femoral head. Femoral neck fractures are very common and account for over 50% of all hip fractures. Standard treatment for fracture neck of femur is surgical. The surgical treatment can either be internal fixation or arthroplasty depending on the age of the patient. The novel technique of FNS developed in 2018 is a relatively minimally invasive procedure which reduces blood loss and infection risk. Biomechanical studies have shown axial and rotational stability, operative time, union rates and stability of FNS are similar to other surgical options while being superior in terms of intraoperative blood loss, non- union, internal fixation failure and betterment of Harris hip scores. There are few reports discussing clinical implementation of FNS out of which most are retrospective in nature and include a small cluster of patients. Intra-operative and Post-operative parameters of FNS have not been fully explored. This study will increase the available data on femoral neck system surgery and may provide more clarity on its outcomes. It will also help in validating the previous studies done by reproducing the results.

 
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