| CTRI Number |
CTRI/2025/03/081834 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of factors which play a significant role in compound shaft of tibia fracture healing in early and delayed intervention done in the form of intramedullary tibia nailing |
|
Scientific Title of Study
|
Outcome Analysis of Factors Affecting Fracture Healing in Immediate versus Delayed Intramedullary Nailing for Compound Fractures of Tibial Shaft. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samarth Kashyap |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
2, department of orthopaedics, jnmc campus, wardha, Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
8951533545 |
| Fax |
|
| Email |
Samarthkashyap06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ratnakar Ambade |
| Designation |
Professor and head of department |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
2, department of orthopaedics, jnmc campus, wardha, Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823033511 |
| Fax |
|
| Email |
drambade@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samarth Kashyap |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
2, department of orthopaedics, jnmc campus, wardha, Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
8951533545 |
| Fax |
|
| Email |
Samarthkashyap06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher education and research, sawangi meghe, wardha, Maharashtra, India. Pin-442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher education and research |
| Address |
Datta Meghe Institute of higher education and research, sawangi meghe, wardha, maharashtra, India
Pincode- 442107 |
| Type of Sponsor |
Private medical college |
|
|
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 Samarth Kashyap |
Acharya Vinobha Bhave Rural Hospital |
2, Department of orthopaedics, Jawaharlal Nehru medical college, sawangi meghe
Pincode- 442107
Wardha
MAHARASHTRA |
8951533545
Samarthkashyap06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
Fracture healing in Early intervention vs Delayed intervention |
Outcome in both types of the intervention |
| Intervention |
intramedullary tibia nailing |
intermediate and delayed nailing being done in the selected types of fracture injuries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of compound Tibia shaft fractures (Until Gustilo Anderson classification grade 3C)
Patients who are willing to take part in study after informed consent. |
|
| ExclusionCriteria |
| Details |
All Pathological fractures of tibia
Tumors
Deformity
Unwilling Patients.
Infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fracture healing in immediate and delayed intramedullary nailing for compound fractures of tibia shaft |
Post op day 0
3 months +/- 1 week post op
6 months +/- 1 week post op
9 months +/- 1 week post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
My purpose of study is to evaluate healing of compound tibia fractures when managed with immediate and delayed intramedullary nailing. Upon evaluation of the factors prevailing during the course of management, after discharge and during follow ups, these factors will be studied and formulated into constructive data tabulations and hence it will be summarised which set of patients had better outcome in terms of fracture healing, pain relief, early mobilisation and resumption of day to day activities. |