| CTRI Number |
CTRI/2024/01/061265 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Thigh bone fracture and its union by using different implants study |
|
Scientific Title of Study
|
Post Market Clinical follow-Up Study to evaluate the safety and performance of femoral neck system, dynamic hip system or cannulated cancellous screws in patient with femoral neck fracture |
| 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 Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
|
| Address |
Auxein Medical Pvt Ltd
Plot No. 168-170
Phase IV, HSIIDC,
Insdutrial Estate, Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxeinmedical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
|
| Address |
Auxein Medical Pvt Ltd
Plot No. 168-170
Phase IV, HSIIDC,
Insdutrial Estate, Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxeinmedical.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Gaurav Luthra |
| Designation |
Technical Director |
| Affiliation |
|
| Address |
Auxein Medical Pvt Ltd
Plot No. 168-170
Phase IV, HSIIDC,
Insdutrial Estate, Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
gaurav@auxeinmedical.com |
|
|
Source of Monetary or Material Support
|
| Auxein Medical Pvt Ltd
Plot No. 168-170
Phase IV, HSIIDC,
Insdutrial Estate, Kundli -131028, Sonepat, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Auxein Medical Pvt Ltd |
| Address |
Auxein Medical Pvt Ltd
Plot No. 168-170, Phase IV, HSIIDC, Industrial Estate, Kundli-131028, Sonipat Haryana
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samarth Mittal |
JPNA Trauma Center AIIMS |
Room no. 409
Department of Orthopedics
Ring Road Raj Nagar
Safdarjung Enclave
New Delhi 110029
South
DELHI |
9013562489
samarthmittal@gmail.com |
| Dr Abhishek Kayshap |
Lok Nayak Jai Prakash Hospital |
Room No- 603, Department of Orthopedic Surgery, New Orthopedic Block, Maulana
Azad Medical College & Associated Lok Nayak Hospital, New Delhi - 110002
New Delhi
DELHI |
9716005800
drabhishekkashyap8@gmail.com |
| Dr Sandeep Patel |
Postgraduate Institute of Medical Education and Research |
Department of Orthopedic Surgery, Post Graduate Institute of Medical Education and Research (PGIMER), Sec 12, Chandigarh (India) 160012
|
9901440404
sandeepdrpatelortho@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, MAMC New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral Neck system, Dynamic Hip Compression System, Cannulated Cancellous Screws |
12 Months intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject is willing and able to give informed consent for participation in the study.
2.Male and female above 18 years to 55 year skeletally mature patients.
3.Subject with Femoral Neck Fracture of III and IV class (Garden Classiï¬cation) schedule for FNF surgery. |
|
| ExclusionCriteria |
| Details |
1.Pathological fractures,open fractures or other fractures including poly- trauma, stress fractures of the femoral neck
2.Local infection in the hip joint before the ï¬xation surgery.
3.Patient with previously diagnosed osteoporosis.
Fracture-dislocation of the femoral neck and hip joint.
4.Likely problems, in the judgement of the attending surgeon, with maintaining follow up.
5.Patients with severe mental disorders and 6.psychotropic drug addictions.
7.Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To asses the safety and performance of femoral neck system at 1 year follow-up
2.To asses the safety and performance of dynamic hip system till 1 year follow-up
3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up. |
0,1,3,6,12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Complications [Time Frame: baseline, at 1, 3, 6, 12 months postoperatively].
2.Adverse Events
Pain on the affected region using VAS. |
0,1,3,6,12 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
04/09/2027 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 longest and largest bone in the body with abundant blood supply.The Femoral neck fractures occur in 2 to 3 % of skeletal injuries. Femoral Neck fractures(FNF) are widespread orthopedic injury which results in morbidity and mortality. Femoral neck fractures are very common in old age people but treatment of FNF in relatively young patients deserve attention.Femoral neck fractures usually occur by high- energy trauma, that is, fall from high places or high speed accident.The goal of the treatment in young patient is to retain the femoral neck fracture as much as possible to avoid necrosis of femoral head and achieve bone healing. There are about 4 types of distinct patterns as per the Garden fracture classification coded as Type I,II,III and IV.Interventions include surgical treatment of these fractures which lead to reduced mortality and complications. The implants used in surgical treatment for femoral neck fracture are Femoral Neck System, Dynamic Hip System and Cannulated Cancellous Screws. Our Femoral Neck System, Dynamic Hip System and Cannulated Cancellous Screw based on the equivalence of design, production and final product inspection with the predicate device K100238 DEPUY ORTHOPAEDICS, INC DePuy Synthes and is being marketed nationally and globally from the year 2015. No serious adverse effects or complaints have been received till date for the systems. As a manufacturer, Auxein has planned to conduct a Post-marketing clinical follow-up (PMCF) study following the CE marking of the device (Femoral neck System, Dynamic Hip System and Cannulated Cancellous Screw) marketed for its intended use and aims to verify the clinical performance and safety of the implant. We are conducting a prospective post-marketing surveillance study with 1 year post-operative follow-up to update the clinical performance and outcome of our device. Such studies are required by the regulatory authorities for all medical device implants that do not have medium to long-term clinical evidence available at the time of gaining approval to market. |