| CTRI Number |
CTRI/2025/07/090235 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing short and long implants used to treat hip fractures in elderly patients due to trivial trauma. |
|
Scientific Title of Study
|
short versus long proximal femoral nails in
unstable intertrochanteric femur fractures: a comparision of postoperative 30- day mortality, associated factors and functional outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasoon Kumar |
| Designation |
Assitant Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
#15, Nehru Hospital Depatment of Orthopedics, PGIMER, Chandigarh.
Chandigarh CHANDIGARH 160012 India |
| Phone |
9781002142 |
| Fax |
|
| Email |
drprasoonksingh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasoon Kumar |
| Designation |
Assitant Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
#15, Nehru Hospital Depatment of Orthopedics, PGIMER, Chandigarh.
Chandigarh CHANDIGARH 160012 India |
| Phone |
9781002142 |
| Fax |
|
| Email |
drprasoonksingh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prasoon Kumar |
| Designation |
Assitant Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
#15, Nehru Hospital Depatment of Orthopedics, PGIMER, Chandigarh.
Chandigarh CHANDIGARH 160012 India |
| Phone |
9781002142 |
| Fax |
|
| Email |
drprasoonksingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Ethics Committee,Research Block B, PGIMER, Chandigarh,India 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
Research Grant Cell, Research Block A,PGIMER Chandigarh, India 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prasoon Kumar |
Postgraduate Institute of Medical Education and Research |
22 OT, 2nd floor, b block, Nehru Hospital Chandigarh CHANDIGARH |
9781002142
drprasoonksingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M97||Periprosthetic fracture around internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
long nail group |
other half of patients will end up in long nail group based on the length of nail put in patient [300 mm - 420 mm] |
| Intervention |
short nail group
|
half of the patients will end up in short nail group based on the length of nail put in the patient [180 - 240 mm ] |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases of isolated unstable intertrochanteric femur fractures
2.Age more than 50 years
3.Trivial trauma
4.Surgery within 72 hours of injury |
|
| ExclusionCriteria |
| Details |
1. Stable fractures
2. Pathological fractures
3. High energy trauma or polytrauma
4. Immunocompromised patients
5. Local infection
6. Acute MI and Stroke within 1 month
7. Hemiplegic
8. Patient height Less than 5 feet
9. Refuses participation
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare outcomes associated with short and long proximal femur nail anti-rotation in the treatment of unstable inter-trochanteric femur fractures in the elderly and assess factors impacting them. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. Duration of surgery: measured from skin incision to closure
B. Measurement of surgical APGAR score intraoperatively
C. Measurement of presence or absence of delirium preoperatively and
postoperatively using Confusion assessment method (CAM)
D. Duration of hospital stay; measured from date of admission to discharge
E. Functional outcome using MHHS scoring
F. Mortality by post operative day 90 |
90 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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)
|
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
|
Osteoporotic hip fractures in elderly populations are a growing concern worldwide with increasing life expectancy and growing elderly population; these fractures include fractures of the neck of femur and femoral head, intertrochanteric and subtrochanteric femur fractures. Gullberg et al.in 1997 estimated that the incidence of hip fractures worldwide could be upto 2.6 million by the year 2025 and 4.5 million by the year 2050. The intertrochanteric region of femur is located between the greater and lesser trochanters and is composed of dense trabecular bone; these fractures are extracapsular fractures of the proximal femur between the trochanters. These fractures have bimodal age distribution with both the young and the elderly affected; however on one hand high energy trauma is the mode of injury in the young, in the elderly population low energy trivial trauma compounded by osteoporosis is the associated mechanism. Patients most commonly present with a history of pain and inability to ambulate after a fall or other injury. The pain is located at the proximal thigh and is exacerbated by passive or active attempts of hip flexion or rotation. The physical findings are shortening and external rotation of the extremity. As far as the nail designs go, both short and long lengths of the nail are available and there are different types of proximal locks like double screws, spiral blade and single compression screw configurations. Long nails are available with lengths from 260 to 460 mm and short nails from 180 to 200 mm. Long nails potentially avoid stress concentration near the distal end, reducing chances of secondary fractures of the shaft. However, recent studies suggest similar results and deem short nails as safe in terms of failure and re-fractures with added advantage of shorter operative time and lesser blood loss compared to long nails.Surgeries with short nails are faster owing to no requirement of reaming and distal locking can be done with zig itself without need of patient positioning and C-arm. Without reaming, there is additional benefit of lesser chances of intra-operative fat embolism, which can have a critical impact on patient survival post operatively. However, with the limited number of randomized trials on the comparison, the superiority of one design over the other has been a matter of debate. Several studies have reported positive outcomes with both short and long PFNs for intertrochanteric femur fractures; however, conflicting issues remain regarding the superiority of 1over the other. This present study is conceptualised to address this specific question in terms of intra operative parameters like surgical duration, blood loss, surgical APGAR score; post operative parameters like blood transfusions, Confusion Assessment Method (CAM) score, duration of hospital stay, union rates, re-fractures, functional outcomes (MHHS) and 30 day and 90 day mortality rates. Furthermore, preoperative and intra operative factors will be correlated with the post operative outcomes. In the elderly these fractures present a complex scenario because of co-existent one or multiple co-morbidities and overall frailty; they optimally require early surgery and immediate mobilization to minimize the complications associated with recumbency like decubitus ulcers, decreased cardiopulmonary reserves and thromboembolic events, which could be devastating for these old age patients. The IT femur fractures are either stable or unstable with the latter described as fractures with either loss of the medialcalcar, or comminuted lateral wall; reverse oblique configuration of the fracture line also makes the fractures unstable. In terms of implant of choice for internal fixation, the adequacy of dynamic hip screw which has been in vogue for stable fractures, is relatively inferior in the unstable intertrochanteric femur fracture, in comparison to proximal femoral nails. In terms of surgical options for the unstable variety, the choice ranges from internal fixation with proximal femoral nails to hip replacements surgeries; the former has been shown to be superior in respect of ambulation and mortality rates. |