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CTRI Number  CTRI/2020/02/023593 [Registered on: 26/02/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pilot study using scaled preoperative radiographs of the normal side and accessible bony landmarks to restore the limb length of the fracture site during surgery 
Scientific Title of Study   Pilot study using novel technique for restoring the limb length in patients undergoing bipolar cemented hemiarthroplasty, using preoperative scaled radiographs of the normal side 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amir Ratna Shakya 
Designation  Resident, Orthopedics 
Affiliation  Armed Forces Medical College 
Address  Department of Orthopedics Armed Forces Medical College Wanowrie, Solapur road, near race course Pune Pune MAHARASHTRA 411040 India

Pune
MAHARASHTRA
411040
India 
Phone  8484880211  
Fax    
Email  anmishakya@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajay Deep Sud 
Designation  Head of Department of Orthopedics 
Affiliation  Armed Forces Medical College 
Address  Department of Orthopedics Armed Forces Medical College Wanowrie, Solapur road, near race course Pune Pune MAHARASHTRA 411040 India

Pune
MAHARASHTRA
411040
India 
Phone  9167587625  
Fax    
Email  adsud123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amir Ratna Shakya 
Designation  Resident, Orthopedics 
Affiliation  Armed Forces Medical College 
Address  Department of Orthopedics Armed Forces Medical College Wanowrie, Solapur road, near race course Pune Pune MAHARASHTRA 411040 India

Pune
MAHARASHTRA
411040
India 
Phone  8484880211  
Fax    
Email  anmishakya@hotmail.com  
 
Source of Monetary or Material Support  
Armed Force Medical College (AFMC) 
 
Primary Sponsor  
Name  Amir Ratna Shakya 
Address  Department of Orthopedics Armed Forces Medical College Wanowrie, Solapur road, near race course Pune 
Type of Sponsor  Other [AFMC] 
 
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 
Amir Ratna Shakya  Armed Forces Medical College  Department of Orthopedics, Wanowrie
Pune
MAHARASHTRA 
8484880211

anmishakya@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patient with fracture of proximal femur undergoing hemi-replacement arthroplasty as the management 
 
ExclusionCriteria 
Details  Patient being managed with other surgical options like THR
Patient with an operated or affected contralateral hip
Patient unfit for surgery 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Achieve equal leg length in patients of fracture of proximal femur undergoing Hemi-Replacement Arthroplasty by using Scaled Pre-operative radiographs  Post operative period  
 
Secondary Outcome  
Outcome  TimePoints 
To study and analyze the post-operative functional status.  01 and 03 months functional assessment using Harris hip Score (HHS) 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   27/02/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Fracture around proximal femur are a commonly encountered fracture in the older population with a globally increasing incidence. The incidence of the fracture around proximal femur also rises with age. Among the fractures of proximal femur the incidence of intertrochanteric fracture is around 55 % fracture neck of femur is around 32%.

Fractures around the hip are associated with increased mortality rate, incidence being around 8-11% at the end of 30 days and 20-30% at the end of 01 year. A delay in surgery is due to various factors  such as associated co-morbidities requiring pre-operative optimization  in these group of patients and subsequent surgery readiness and resource availability factors such as high volume of cases.

In order to achieve the goals of fracture management the options are primarily surgical with options including reduction and internal fixation or arthroplasty. Arthroplasty can be either Hemi-replacement Arthroplasty (HRA) or Total Hip Arthroplasty (THA). HRA in current practice is of two types: unipolar and bipolar. HRA is generally indicated in older patients with a aim to regain early mobilization and better functional results. HRA prevents the bed ridden state and thus avoids the complications associated with recumbency.

In order to achieve better functional results following HRA the hip biomechanics need to be restored to its native state. The femoral offsets and limb length are the factors that decide the biomechanics of the operated hip. Inability to restore the leg length has shown to be associated with back pain, gait abnormalities, dislocation, prosthesis loosening and poor functional capacity.

Incidence of limb length discrepancy following a HRA with a unipolar prosthesis is as high as 50% when the difference is minimum 10 mm. whereas in bipolar Arthroplasty the incidence decreases but is more when compared to THA

There are various means of reducing the incidence of LLD described in literature in patients undergoing Total Hip Arthroplasty. These methods were broadly classified by Khanduja et al  into 03 groups a) those which rely on preoperative templating and determination of the osteotomy site with intra-operative determination of the osteotomy site in relation to the lesser trochanter; b) those using intra-operative pelvic and femoral markers for reference and; c) experimental methods which employ complex mathematical calculations and ultrasound probes to measure leg lengths accurately. 

However there is limited available literature on methods of reduction of limb length discrepancy in patients of proximal femur fracture undergoing Hemi-replacement Arthroplasty. Methods used are taking reference of the greater trochanter in relation to head of femur on normal side and pre-operative templating and estimating the size of prosthesis 

This study will be undertaken at a tertiary care center in western part of India in patients of fracture of proximal femur undergoing Hemi-replacement Arthroplasty and wherein Pre-operative Scaled Radiograph shall be taken and a novel technique using fixed accessible landmarks will be used to assess the level of cuts intraoperatively with a aim to achieve equal limb length or minimize limb- length discrepancy.

 
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