| CTRI Number |
CTRI/2022/10/046936 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tibia bone related fracture fixation study |
|
Scientific Title of Study
|
Post Marketing Clinical Follow-up Study, a single arm prospective case series to evaluate the safety and effectiveness of Intramedullary Tibia Nailing system intended for Tibia bone related fracture fixation (PMCF-INITIA NAIL) |
| Trial Acronym |
PMCF-INITIA NAIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay Gupta |
| Designation |
Senior Consultant Orthopedics |
| Affiliation |
Eternal Hospital, A Unit of Eternal Heart Care Center & Research Institute |
| Address |
Eternal Hospital,
A Unit of Eternal Heart Care Center & Research Institute Private Limited,
3 A ,Jagatpura Road,
Near Jawahar Circle,
Jaipur
Jaipur RAJASTHAN 302017 India |
| Phone |
|
| Fax |
|
| Email |
vinaygupta.tnmc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Lokesh Chauhan |
| Designation |
Clinical Research Manager |
| Affiliation |
Kaulmed Private Limited |
| Address |
Kaulmed Private Limited
Plot no 157,
Phase V, HSIIDC,
Kundli Industrial Area, Sec-56, Sonipat
Sonipat HARYANA 131028 India |
| Phone |
|
| Fax |
|
| Email |
lokesh.chauhan@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gaurav Luthra |
| Designation |
Technical Director |
| Affiliation |
Kaulmed Private Limited |
| Address |
Kaulmed Private Limited
Plot no 157,
Phase V, HSIIDC,
Kundli Industrial Area, Sec-56, Sonipat
Sonipat HARYANA 131028 India |
| Phone |
|
| Fax |
|
| Email |
gaurav@kaulmed.com |
|
|
Source of Monetary or Material Support
|
| Eternal Hospital, Jaipur, Rajasthan |
| KAULMED Private Limited, Sonipat, Haryana |
|
|
Primary Sponsor
|
| Name |
Kaulmed Pvt. Ltd. |
| Address |
Kaulmed Private Limited
Plot no 157,
Phase V, HSIIDC, Kundli Industrial Area, Sec-56, Sonipat, Haryana -131028 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aseem Gupta |
Akhila Hospital, Jaipur |
Akhila Hospital, Paldi Meena, Agra Road Jaipur-303012 Jaipur RAJASTHAN |
9460555573
aseemgupta1978@gmail.com |
| Dr Vinay Gupta |
Eternal Hospital, A unit of Eternal Heart Care Center & research Institute Private Limited |
3A, Jagatpura Road, Near Jawahar Circle, Jaipur Jaipur RAJASTHAN |
7665075430
vinaygupta.tnmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Eternal Heart Care and Research institute- Institutional Ethics Committee |
Approved |
| Eternal Heart Care and Research institute- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Tibia Nailing System |
Intended for fracture fixation of Tibia bone; Single use device for more than 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject is willing and able to give informed consent for participation in the study
2. Male or Female, aged 18 years or above, skeletally mature patient.
3. Subject is willing and able to complete required study visits or assessments.
4. Subject diagnosed as per indications. |
|
| ExclusionCriteria |
| Details |
1. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
2. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC)
3. Subjects unwilling to sign the Informed Consent document.
4. Subjects who are incarcerated or have pending incarceration.
5. Female participant who is pregnant or planning pregnancy during the course of the study.
6. Fracture that are not amenable to intramedullary tibia nailing technique
7. Morbid obesity (BMI (Kg/m2)) > 35 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of functional performance from baseline to last follow up by recording the Lower extremity functional score (LEFS). |
Visit - Screening, 1, 2, 3, 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Safety of Device by record of any adverse event, serious adverse event and complication during follow up, especially the one mentioned in the Instruction of Use. (IFU) |
Visit - Pre-surgery, Post-surgery, 1, 2, 3, 4 |
| Follow-up of the patient’s recovery by a analysing Visual analogue score (VAS) for pain assessment. |
Visit - Screening, Pre-surgery, Post-surgery, 1, 2, 3, 4 |
| Radiologic Evaluation (X-Ray) |
Screening, Pre-surgery, Post-surgery, 1,2,3,4 |
| Assessment Quality of Life (QOL) by SF-12 |
Screening, 1, 2, 3, 4 |
| Duration of Hospital stay, Revision rate (Removal of any Component), Re-operation Rate. |
12 Months |
| Mortality. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The most common and major fractured bone in the leg is considered to be a tibia bone. The fracture can lead to long hospital stay and can affect the life of the patient socially, mentally and professionally as well. Because of many factors , these injuries are not easy to manage. These factors includes limited soft tissue cover, poor vascularity of the injured area. The most recognized complications includes infection, mal-union, and non-union (Achten et al., 2015). Intramedullary nailing is considered as the gold standard of care for tibia shaft fracture. This is so because it helps in the reduction of surgical insult to the fractured and soft tissue (Attal et al., 2012).The incidence of tibia fracture has been varied from years across different countries and culture. One study has concluded that males have highest rate of incidence which is recorded as 21.5/1000000/year when compared with the rate of women. The highest frequency of fractures lies between the age of 10-20 years (Larsen et al., 2015). According to AO classification, the most common type of fracture recorded was type 42-A1 which constitutes of 34% of total tibial shaft fracture (Larsen et al., 2015). There are many techniques which are used for the operative management of the fractures. These techniques includes intra-medullary implants, half-pin external fixation, hybrid thin-wire external fixation, and plate fixation. In recent years, intramedullary nailing technique is widely used for proximal and distal tibial metaphyseal fracture (Meena et al., 2015). Out of these techniques, most widely used are minimally invasive Plating and Intramedullary Nailing technique. Intramedullary Nailing provides better functional outcomes and provides required mechanical stability and better fracture alignment. Intramedullary tibia nails can be implant via different approached including reamed & unreamed, compression and non compressive and locking options include static, dynamic and dynamic compression (Duygun, 2018). In this post-marketing clinical follow-up study, the safety and effectiveness of intramedullary nailing system, which is intended for Tibia bone related fracture would be studied. |