| CTRI Number |
CTRI/2024/11/077087 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Functional outcome of proximal tibia fracture managed with intramedullary nail and LCP |
|
Scientific Title of Study
|
A Prospective study, outcome of combined intramedullary nail and plate fixation in proximal tibia fractures. |
| 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 Rishabh Kumar |
| Designation |
PG STUDENT |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of orthopaedics, Rajendra institute of medical sciences
Room no 5 boys hostel 5 rims
Ranchi
JHARKHAND
834009
India |
| Phone |
08409846999 |
| Fax |
|
| Email |
rishavsrivastava.pns9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Kumar Gupta |
| Designation |
Head of department, department of orthopaedics |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of orthopaedics, Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8235068192 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govind Kumar Gupta |
| Designation |
Head of department, department of orthopaedics |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of orthopaedics, Rajendra institute of medical sciences, Ranchi
JHARKHAND
834009
India |
| Phone |
8235068192 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rajendra institute of medical sciences , RANCHI 834009 JHARKHAND , INDIA |
|
|
Primary Sponsor
|
| Name |
Rajendra institute of medical sciences |
| Address |
Department of orthopaedics, Rajendra institute of medical sciences,Ranchi , 834009 , Jharkhand, India |
| Type of Sponsor |
Government 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 Rishabh Kumar |
Rajendra institute of medical sciences |
Department of orthopaedics, rims Ranchi
Ranchi
JHARKHAND |
08409846999
rishavsrivastava.pns9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, rims, Ranchi |
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 |
Intramedullary nail and plate fixation in proximal tibia fractures. |
To evaluate clinical, radiological and functional outcome over a period of 1 year in cases of proximal tibia fractures managed with intramedullary nail and plate (LCP). |
| Comparator Agent |
Proximal tibia fractures managed with other mode of treatment. |
Functional , clinical and radiological outcomes of proximal tibia fractures managed with other treatment options, like conservative management, bicoloumnar plating of proximal tibia etc for a period of 1 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Proximal tibia fractures |
|
| ExclusionCriteria |
| Details |
1.Patients with age less than 18 years and more than 70 years
2.Patients with previous history of any major orthopaedic operation of the involved limb
3.Patients with pathological fractures.
4.Patients with distal tibia fractures.
5.Patients having serious medical comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the functional outcome |
A) Post operative 3 month
B) Post operative 6 month
C) Post operative 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) to assess radiological union status
B) to assess clinical union status |
A) Post operative 3 month
B) Post operative 6 month
C) Post operative 1 year |
|
|
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)
|
01/12/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Proximal tibia fractures can be managed with intramedullary nail , LCP or combination of both, in this study we will assess the functional, radiological and clinical outcome of proximal tibia fractures managed with combination of intramedullary nail and LCP. |