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CTRI Number  CTRI/2024/05/067599 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study mortality in elderly people after pelvic and femur fracture with evaluation of estimated blood loss during surgery and preoperative and postoperative blood parameter.  
Scientific Title of Study   To study one-month and six month mortality following surgery of femur and pelvic fractures in elderly patients 
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 Pradyumna Krishna M 
Designation  Associate Professor 
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Department of Orthopaedics Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8059220723  
Fax    
Email  pradyumnakm2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul 
Designation  Junior Resident 
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Department of Orthopaedics Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9671652644  
Fax    
Email  rahul.singoria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul 
Designation  Junior Resident 
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Department of Orthopaedics Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9671652644  
Fax    
Email  rahul.singoria@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak 
Address  Department of Orthopaedics Pt B D Sharma PGIMS Rohtak 
Type of Sponsor  Government 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 Rahul  Pt B D Sharma PGIMS Rohtak  Research Lab, Department of Orthopaedics,Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA 
9671652644

rahul.singoria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality, (2) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  61.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Femur fracture
2 Pelvic fracture
3 Age ≥ 60 years
4 Patients requiring internal fixation
 
 
ExclusionCriteria 
Details  1 Pathological fractures
2 Elective procedures for lower limb
3 Paralyzed patients
4 Psychiatric patients
5 Fractures other than, femur and pelvis
6 Polytrauma patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study one-month and six month mortality following surgery of femur and pelvic fractures in elderly patients  follow up at one and six month from day of injury 
 
Secondary Outcome  
Outcome  TimePoints 
To look for cause of early mortality due to surgery related complication or other etiology.  follow up at one & six month from day of injury 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   07/06/2024 
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="0"
Months="6"
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  

Lower limb fractures constitute a high burden of trauma, where mortality is an important statistical means of the quality of healthcare received. Fractures around the hip and knee diaphyseal fractures of the femur and pelvis are significantly associated with postoperative mortality. Time to surgery, nature of the injury, patient factors including age, sex, comorbidities, American Society of Anesthesiologists (ASA) score and acute management of trauma are associated with mortality following fractures of the lower limb.1

Delays to surgery after a hip fracture have been extensively studied in the Western population as a factor that affects patient survival.2,3 Despite recent large cohort studies and older meta-analyses, uncertainty remains as to what benchmark should be utilized as a marker of quality of care to improve patient outcomes.4 Recent international guidelines have suggested that 24 or 36 hours may be more appropriate clinical benchmarks for the timing of surgery to improve patient outcomes. The evidence supporting these new recommendations for an earlier time for surgery is currently limited.5

Elderly patients who sustain a hip fracture and undergo a surgical procedure have a high risk for postoperative complications, including pneumonia, heart failure and death. Prior studies have identified older age, cardiovascular disease, respiratory disease and prior stroke as risk factors for postoperative complications.6,7 In Scotland, just over 6,000 patients per year sustain a fracture of the hip of which 95% are treated surgically.8

Lower limb fractures are a significant healthcare problem in the elderly, affecting 1.5 million people per year worldwide. This number is expected to increase to 2.6 million by 2025 and 4.5 million by 2050 due to the aging population. The consequences of a hip fracture can be serious; one-third of the patients die within the first year postoperatively.9 The mortality rate is highest in the early postoperative period, reaching up to 13.3% within the first 30 days after surgery.10

Numerous risk factors for early mortality following hip fracture surgery have been reported, however, study designs are inconsistent and the selection and definition of variables vary.11 Given how common hip fractures are, it is important to obtain knowledge about these risk factors to optimise the quality of care. Identification of patients at high risk for early mortality is beneficial, to inform the patient about the prognosis of hip fracture surgery and to customize care. A simple scoring system is essential for such a preoperative identification in daily clinical practice. Various risk models for early mortality following hip fracture surgery have been published.12

The Nottingham Hip Fracture Score (NHFS) shows the most promising results so far. However, there is still room for improvement. With the NHFS, more than 87% of the patients score a risk of 30-day mortality of 11.8% or lower.13 These poor differentiating percentages are insufficient for clinical decision-making. An appropriate cutoff point defining a high-risk group is useful but has never been validated. Besides that, external validation of the risk model outside the United Kingdom is limited.14

Elderly patients who underwent surgery beyond four days of fracture distal femur versus 48 hours after admission had greater six-month and one-year mortality risks.15 
 
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