| CTRI Number |
CTRI/2025/04/084021 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Role of Cement Augmentation in the Advanced Trochanteric Femoral Nail in Hip fracture surgeries
|
|
Scientific Title of Study
|
Outcome of Osteoporotic Intertrochanteric Fractures treated with Cement Augmented Fenestrated Spiral Blade Cephalomeduallary Device In Elderly Population |
| Trial Acronym |
OIF-CAB study (Osteoporotic Intertrochanteric Fractures - Cement Augmented Blade)
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S P SIVAKUMAR |
| Designation |
CONSULTANT ORTHOPEDIC SURGEON |
| Affiliation |
GANGA MEDICAL CENTRE HOSPITAL |
| Address |
Department of Orthopaedics and Trauma Surgery
Ganga Medical Centre and Hospitals
SaibabaColony
No 283a,b Trichy Road, Ondipudur, Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994465917 |
| Fax |
|
| Email |
drspsiva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSPSIVAKUMAR |
| Designation |
CONSULTANT ORTHOPEDIC SURGEON |
| Affiliation |
GANGA MEDICAL CENTRE HOSPITAL |
| Address |
Dept of Orthopaedics and Trauma Surgery,
GANGA MEDICAL CENTRE HOSPITAL
Saibaba colony
COIMBATORE
No 283 a,b Trichy Road, Ondipudur
Coimbatore - 641016
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994465917 |
| Fax |
|
| Email |
drspsiva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSPSIVAKUMAR |
| Designation |
CONSULTANT ORTHOPEDIC SURGEON |
| Affiliation |
GANGA MEDICAL CENTRE HOSPITAL |
| Address |
Dept of Orthopaedics and Trauma Surgery ,GANGA MEDICAL CENTRE HOSPITAL, Saibaba Colony
COIMBATORE
No 283 a, b Trichy Road, Ondipudur, Coimbatore -641016
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994465917 |
| Fax |
|
| Email |
drspsiva@gmail.com |
|
|
Source of Monetary or Material Support
|
| AO Asia Pacific Limited
Unit 1310-11,Tower 1,Millinennium city 1,388 Kwun tong road,Kowloon,Hongkong |
|
|
Primary Sponsor
|
| Name |
AO Asia-Pacific Limited |
| Address |
unit 1310-11,Tower 1,Millennium city 1,388 Kwun Tong Road,Kowloon,Hongkong |
| Type of Sponsor |
Research institution |
|
|
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 Sivakumar S P |
Ganga Medical Centre and Hospital |
Dept of Orthopaedics & Trauma A block 313 Mettupalayam Road Saibaba Colony
Coimbatore
TAMIL NADU |
9994465917
drspsiva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board of ganga hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
inclusion:
1.AO/OTA-31-A1,A2
2.T-score of less than -2.5 |
|
| ExclusionCriteria |
| Details |
1.Pathological fracture
2.Multiple trauma
3.Delayed fracture more than 2 weeks |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The purpose of this
research was to assess the effectiveness of the new generation Trochanteric Femoral Nail Advanced
(TFNA)with perforated helical blades with cement augmentation and assessment of outcome in the osteoporotic hip fractures postoperatively. |
4 weeks, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
A study evaluating the significance of using Dual energy X-ray absorptiometry and osteoporosis profile for the outcome evaluation of osteoporotic individuals having intramedullary fixation with cement augmentation and uncemented has not been published in any of the literature. However In human cadaveric research, cement augmentation of hip fracture implants has been investigated to enhance implant stability. To improve the implant-bone interface, cement is injected into the osteoporotic bone of femoral head. The purpose of this research was to assess the effectiveness of the new generation Trochanteric Femoral Nail Advanced (TFNA)perforated helical blade cement augmentation or uncemented TFNA method to get the good outcome in the osteoporotic individual and the cement distribution in the femoral head postoperatively. |