| 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
|
|
|
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
|
|
|
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 signiï¬cant 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 ï¬rst 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. Identiï¬cation of patients at high risk for early mortality is beneï¬cial, 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 identiï¬cation 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 insufï¬cient for clinical decision-making. An appropriate cutoff point deï¬ning 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 |