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CTRI Number  CTRI/2023/05/052518 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 10/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Difference between two types of treatment of hip fractures  
Scientific Title of Study   The comparison of Clinical, Radiological and Functional outcome of Femoral Neck System and Dynamic Hip Screw in Femoral Neck Fractures in Young Adults - A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ira Pachori 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Ab1 ward orthopaedics, main AIIMS building, Ansari nagar east

New Delhi
DELHI
110029
India 
Phone  9871380041  
Fax    
Email  ira.pachori@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samarth Mittal  
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Jai prakash Narayan Apex Trauma Centre, AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  9013562489  
Fax    
Email  Samarthmittal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ira Pachori 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Ab1 orthopedics ward, main AIIMS building, Ansari nagar east, new delhi

New Delhi
DELHI
110029
India 
Phone  9871380041  
Fax    
Email  ira.pachori@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
Jai Prakash Narayan Apex Trauma Center AIIMS New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar East New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ira Pachori  All India Institute of Medical Sciences , Ansari Nagar East, New Delhi   Department of Orthopaedics
New Delhi
DELHI 
9871380041

ira.pachori@gmail.com 
Dr Ira Pachori  Jai Prakash Narayan Apex Trauma Center   Department of Orthopaedics
New Delhi
DELHI 
9871380041

ira.pachori@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Post Graduate Research in Clinical Science  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  Dynamic Hip Screw  Surgery should take 1-1.5 hours 
Comparator Agent  femoral neck system  Surgery should take 1-1.5 hours 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Isolated unilateral intracapsular femoral neck fractures
2. patients aged 16-60 years
3. Patients giving consent for study 
 
ExclusionCriteria 
Details  1. Patients with Sepsis
2. Patients with history of malignant primary or metastatic tumors
3. Open fractures
4. Basicervical fractures
5. Associated Ipsilateral femoral shaft / Distal femur fracture
6. History of any other comorbidity which may affect the gait of ipsilateral limb
7. Fracture due to pathological bone lesion at local site
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Radiological fracture union :
RUSH score
 
At 6-month mark
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient mobilization with walker: full weight bearing or as per patient tolerance  POD 1 
Modified Harris Hip Score, International Hip Outcome Score-33, milestone diary , Passive Range of Motion  POD 14 , 6 weeks , 3 months , 6 months post-operatively 
Development of:
1.Non-Union
2. Mal-union
3.Implant cut-out
4. Avascular necrosis of femoral head
5. Fracture of implant system
6. Fracture of femur under implant system
 
X-ray pelvis with bilateral hip AP view with ipsilateral thigh with hip AP/ Lateral views on POD 2 , POD 14 , 6 weeks , 3 months , 6 months post-operatively and NCCT pelvis with bilateral hip on POD 2, 6 months post-operatively 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   15/05/2023 
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   Not applicable  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hip fractures are one of the most common and debilitating fractures in Orthopaedics, estimated to increase to 2.6 million in 2025 of which approximately 50% of cases are predicted to be of femoral neck fractures. Femoral neck fractures may be extracapsular (subtrochanteric, pertrochanteric, intertrochanteric) or intracapsular, which may be classified as Subcapital, Transcervical or Basicervical.

Intracapsular femoral neck fractures are common in the elderly population after a trivial fall , while those in young adults are often the result of high-energy trauma2. They are associated with higher incidences of femoral head osteonecrosis and non-union.  The blood supply to the femoral head is tenuous and easily injured in the setting of displaced fractures. In severely displaced fractures, only the contribution from the obturator artery through the ligamentum teres may be preserved. In addition, other mechanisms of disruption have been hypothesized including tamponade due to compression from an intracapsular hematoma, traction or malrotation during reduction, or eventual thrombosis due to improper reduction. Femoral neck fractures are intra synovial, and the periosteum lacks a cambium layer, hence there is a decreased supply of pluripotent cells, and the fracture hematoma is constantly lavaged away by synovial fluid. Thus, secondary fracture healing is not promoted. Rather, only direct fracture healing via osteonal remodelling is possible. This type of bone healing requires an anatomic reduction and compression. Primary healing may occur if there is a small gap in a process known as gap healing. However, healing is hindered by the high shear stress environment of femoral neck fractures .  

The incidence of non-union after femoral neck fracture has been reported to be between 10% to 33% ,which increases with age. The rate of osteonecrosis reported in the literature ranges from 12%-86% in young patients after femoral neck fracture . This devastating complication may lead to collapse of the femoral head and subsequent osteoarthritis. Reported incidence of AVN in fracture neck of femur in young adults is <15% (0-67%). Other functional complications that occur such as posttraumatic arthritis, chronic pain and  limb length shortening  occur which cause a prolonged loss of function in these patients, placing a large burden on the country’s economy and healthcare system .

Fractures that occur in this normal bone density population require substantial axial load with the hip in an abducted position. The clinical evaluation of these patients requires a thorough trauma workup because they frequently have other associated injuries. Despite this, diagnosis and treatment of femoral neck fractures in young adults should only be superseded by other life and limb-threatening injuries. The clinical presentation of patient with femoral neck fracture will usually show a shortened, flexed and externally rotated leg. Radiographic evaluation should include antero-posterior (AP) pelvis with bilateral hips, and lateral plain radiographs of the hip joint.

The fracture pattern seen in young adults will be influenced by their better bone quality and higher energy mechanism. The axially loaded mechanism onto an abducted hip will often result in a basicervical or more distal neck fracture; the fracture pattern has a tendency to be more vertically oriented and thus is biomechanically more unstable. These characteristics have important implications in terms of obtaining and maintaining stable fixation to allow healing to occur.

In the young adult the main goals are to preserve the femoral head, avoid non-union and avoid osteonecrosis by anatomic reduction and stable internal fixation of the femoral neck fracture. Arthroplasty procedures are not ideal given the younger age and high functional levels.

Traditionally, efforts are made to treat and stabilize these fractures within 24 hours of injury, with some citing improved outcomes with reduction and fixation in less than 6 hours. It has been found that young patients who are treated within 24 hours are shown to have lower inpatient medical and surgical adverse events .

Operative treatment options mainly include two interventions: CCS (Cancellous Cannulated Screws), SHS (Sliding Hip Screw)/ DHS (Dynamic Hip Screw).

Cannulated screw fixation of young femoral neck fractures typically involves the placement of 3 screws in an inverted triangle configuration. Other configurations have been

described, such as the addition of a fourth screw transversely into the calcar,3 screws converging, 4 screws converging.  CCS are of two types i.e., Partially threaded CCS which allow for compression across the fracture, whereas fully threaded screws do not. They have the advantage of low cost, less bone removal but have some disadvantages like lack of control over fracture compression, inability to provide fixed angle stability, and often settle and heal with a shortened femoral neck disrupting neck–shaft offset and functional hip abductors which is associated with lower quality of life and increased revision rates.

Most important disadvantage is post-operative collapse which is really significant in CCS.

Fully threaded screws are generally not used due to lack of compression and micromotion that are required for fracture union causing high failure rates.

A sliding hip screw is a fixed-angle device that allows for compression. Although shown to be biomechanically superior, by resisting shear and varus collapse , due to their locking and length stable nature, this advantage is not seen in clinical studies done . SHS/DHS have high failure rates due to excessive stiffness, non-union and loss of reduction .

Complicated fracture patterns such as displaced, comminuted and Pauwel’ Grade III show better outcomes when managed with DHS 12, although the complication rates are higher as the surgery is of a more invasive nature than CCS.

 A new generation of implants is emerging- like The Femoral Neck System (FNS) which has an articulated blade and screw construct that exerts no rotational moment on the head segment and is protective of an anatomic provisional reduction. Early results of FNS are promising worldwide.

One prospective study , one retrospective single centre study and one cadaveric study has been published to this date comparing the clinical outcome, and biomechanical evaluation, respectively, of FNS and DHS.

This prospective clinical trial will be performed to assess and compare clinical, functional and radiological outcomes and complications with the use of the recently launched and approved treatment modality - Femoral Neck System with the current commonly used treatment modality,  Dynamic Hip Screw with Derotation Screw in treatment of neck of femur fractures in young adults.

 
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