| CTRI Number |
CTRI/2025/01/079602 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The management and outcomes of Femur fractures around the world |
|
Scientific Title of Study
|
Fracture Evaluation Management & Understanding Research (FEMUR): A prospective global cohort study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bobby John |
| Designation |
Professor |
| Affiliation |
Christian Medical College & Hospital Ludhiana |
| Address |
Department of Orthopaedics, Christian Medical College &Hospital Ludhiana, Brown Road, Punjab 141008
Ludhiana PUNJAB 141008 India |
| Phone |
9815333601 |
| Fax |
|
| Email |
bobby.john@cmcludhiana.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bobby John |
| Designation |
Professor |
| Affiliation |
Christian Medical College & Hospital Ludhiana |
| Address |
Department of Orthopaedics, Christian Medical College &Hospital Ludhiana, Brown Road, Punjab 141008
PUNJAB 141008 India |
| Phone |
9815333601 |
| Fax |
|
| Email |
bobby.john@cmcludhiana.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhishek Samuel |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College & Hospital Ludhiana |
| Address |
Department of Orthopaedics, Christian Medical College &Hospital Ludhiana, Brown Road, Punjab 141008
Ludhiana PUNJAB 141008 India |
| Phone |
9888391208 |
| Fax |
|
| Email |
abhisheksamuel24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Non Funded Study
The study in India is coordinated by:
Department Of Orthopaedics And the India Hub, NIHR Health Research Unit on Global Surgery
Christian Medical College, Ludhiana, Punjab, 141008
India |
|
|
Primary Sponsor
|
| Name |
University of Birmingham |
| Address |
Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham, B152TT, United Kingdom, researchgovernance@contacts.bham.ac.uk |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Afghanistan Albania Australia Belgium Benin Bosnia and Herzegovina Brazil Bulgaria Burundi Cameroon Canada Chile Colombia Croatia Cyprus Democratic Republic of the Congo Denmark Djibouti Ethiopia France Germany Ghana Greece Haiti Hong Kong India Indonesia Iran (Islamic Republic of) Ireland Israel Italy Jordan Kazakhstan Kenya Lesotho Liberia Macedonia Malawi Malaysia Malta Mexico New Zealand Nicaragua Nigeria Norway Oman Pakistan Peru Philippines Poland Portugal Qatar Republic of Korea Romania Russian Federation Rwanda Saudi Arabia Singapore Solomon Islands Somalia South Africa Spain Sri Lanka Sudan Tanzania Turkey Uganda United Arab Emirates United Kingdom United States of America Uruguay Venezuela (Bolivarian Republic of) Zambia Zimbabwe |
|
Sites of Study
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prateek Behera |
All India Institute of Medical Sciences, Bhopal |
Department of Orthopaedics, All India Institute Of Medical Sciences, Bhopal , Madhya
Pradesh (462020)
Bhopal MADHYA PRADESH |
9348068486
prateek.ortho@aiimsbhopal.edu.in |
| Dr Samarth Mittal |
All India Institute of Medical Sciences, New Delhi |
Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS), New Delhi 110029 East DELHI |
9013562489
samarthmittal@gmail.com |
| Dr Bhaskar Sarkar |
All India Institute of Medical Sciences, Rishikesh |
Department of Orthopaedics, All India Institute of Medical Science Rishikesh, Uttarakhand (249203)
Dehradun UTTARANCHAL |
8872878619
drbhaskarsarkar@gmail.com |
| Dr Deny Kurien Mathew |
Believers Church Medical College & Hospital, Thiruvalla |
Department of Orthopaedics
Believers Church Medical College & Hospital, Thiruvalla, Kerala (689103) Pathanamthitta KERALA |
9790359369
denymathew15@gmail.com |
| Dr Bobby John |
Christian Medical College Hospital Ludhiana |
Department of Orthopedics, Christian Medical College Hospital Ludhiana, Punjab,141008 Ludhiana PUNJAB |
9815333601
bjohncmc@gmail.com |
| Dr Schine Kale |
D Y Patil Medical College & Hospital Nerul, Navi Mumbai |
Department of Orthopaedics, D Y Patil Medical College & Hospital Nerul,Navi Mumbai 400706 Mumbai MAHARASHTRA |
9821431687
sachin.kale@dypatil.edu |
| Dr Anupam Mahajan |
Dr B.R. Ambedkar State Institute of Medical Science, Mohali |
Department of Orthopaedics, Dr B.R. Ambedkar State Institute of Medical Science, Mohali Punjab 160055 Rupnagar PUNJAB |
9815333663
dranupammahajan@gmail.com |
| Dr Sanjeev Gupta |
Government Medical College, Jammu J &K |
Department of Orthopaedics, Government Medical College, Jammu J &K 180001 Jammu JAMMU & KASHMIR |
8082787906
dr.sanjeev123@gmail.com |
| Dr Nitin Kimmatkar |
Government Medical College, Nagpur, |
Department of orthopaedics
Government Medical College and Hospital, Near Hanuman Nagar, Nagpur, Maharashtra - 440003 Nagpur MAHARASHTRA |
9823078806
kimmatkarnitin@gmail.com |
| Dr Amandeep Singh Bakshi |
Government Medical College, Rajindra Hospital, Patiala |
Department of orhtopaedics, Government Medical College, Rajindra Hospital, Patiala Patiala PUNJAB |
9915745003
dramangomco@gmail.com |
| Dr kirubakaran Pattabiraman |
Jawaharlal Institute Of Postgraduate Medical Education And Research (JIPMER) Pudducherry |
Department of Orthopaedics
Jawaharlal Institute Of Postgraduate Medical Education And Research (JIPMER) Pudducherry Pondicherry PONDICHERRY |
9814142209
kiru2209@gmail.com |
| Dr Yash Shah |
PMC hospital Kamla Nehru hospital , Pune, Maharashtra |
Department of Orthopaedics
PMC hospital Kamla Nehru hospital , Pune, Maharashtra Pune MAHARASHTRA |
7822073482
dr.yashshah@gmail.com |
| Dr Vishal Kumar |
Postgraduate Institute of Medical Education & Research Chandigarh |
Department of Orthopaedics Postgraduate Institute of Medical Education & Research Chandigarh, 160012 Chandigarh CHANDIGARH |
7009034172
drkumarvishal@gmail.com |
| Dr Amiya Bera |
Raiganj Government MCH, Raiganj |
Department of Orthopaedics,Raiganj Government MCH, Raiganj, West Bengal Uttar Dinajpur WEST BENGAL |
8016714403
dr.a.k.bera@gmail.com |
| Dr Vivek Sodhai |
Sancheti Institute for Orthopaedics & Rehabilitation, Pune |
Sancheti Institute for Orthopaedics & Rehabilitation, Pune, Maharashtra (411005) Pune MAHARASHTRA |
9921241790
vivek.sodhai89@gmail.com |
| Dr Krishan Kumar |
SRK Hospital and Trauma Centre Pathankot |
Department of orthopedics
SRK Hospital and Trauma Centre Pathankot, Punjab (145001)
Gurdaspur PUNJAB |
9216804020
drkkortho@gmail.com |
| Dr Vinutha Gowda |
St.Johns Medical College, Banglore |
Department of Orthopaedics, St.Johns Medical College, Banglore, India 560034 Bangalore KARNATAKA |
9535777107
vinuthabw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics committee (IEC)and Biomedical and Health Research |
Approved |
| Institutional Ethics Committee AIIMS Bhopal |
Approved |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
| Institutional Ethics Committee BR Ambedkar State Institute of Medical Sciences, Mohali |
Approved |
| Institutional Ethics Committee GMC Jammu |
Approved |
| Institutional Ethics Committee GMC Patiala |
Approved |
| Institutional Ethics Committee PGI Chandigarh |
Approved |
| Institutional Ethics Committee St. Johns Medical College Bangalore |
Approved |
| Institutional Ethics Committee, Christian Medical College & Hospital, Ludhiana, Punjab |
Approved |
| Sancheti Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M978||Periprosthetic fracture around other internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
- Adult (over 18 years of age) participants of any sex who are admitted to a facility
for definitive management of a femur fracture
- Patients receiving emergency and elective procedures should be included.
- Patient management can include non-operative and/or operative treatment of
the femur fracture. |
|
| ExclusionCriteria |
| Details |
- Minors under 18 years of age will be excluded.
- Repeat hospital admissions for the same femur fracture will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To audit mortality, morbidity, and mobility outcomes 30 days after admission with
femur fractures globally
- To describe the management of femur fractures in hospitals globally |
30 day follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="4424" Sample Size from India="1000"
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)
|
07/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The femur is the largest bone in the body and femur fractures are common after injuries, globally. Femur fractures are psychologically traumatic for patients, causing severe pain and disability or death if not well managed. Multiple types of femur fracture exist, with some types being associated with high mortality rates and disability than others. However, evidence also suggest that for any given type of femur fracture, outcomes vary dramatically dependent on the geographical location of the patient. Patient age, sex, delays prior to receiving management, duration of surgery, preoperative physiological state, and management received also influence outcomes. Evidence on outcomes after femur fracture and comparisons between management strategy and geographical regions is useful for raising awareness of disparities in quality of care and for health system planning. This evidence is currently lacking from the global literature.
The aim of this study is to understand the management provided for different types of femur fractures that are admitted to hospitals globally, and the outcomes for patients with these fractures.
1. To audit mortality, morbidity, and mobility outcomes 30 days after admission with femur fractures globally 2. To describe the management of femur fractures in hospitals globally In comparing outcomes by management received, facility type, and global location, we will provide data to inform health system planning and utility for global advocacy.
This is a prospective, multicentre, cohort study conducted by the FEMUR Collaborative. The Collaborative consists of an international central team, national leads, hospital leads, and data collection teams. National and hospital leads will be purposely recruited through personal invitations to colleagues, orthopedic professional associations and informal networks, the rural doctor’s association, and social media. The central team will provide support to national and hospital leads through monthly webinars and WhatsApp group chats.
|