| CTRI Number |
CTRI/2024/01/061496 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparision between External fixator vs Supracutaneous plating in the treatment of open Tibia fractures
|
|
Scientific Title of Study
|
“EVALUATION OF FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF OPEN TIBIA FRACTURE TREATED WITH SUPRACUTANEOUS PLATING VS EXTERNAL FIXATORâ€- A PROSPECTIVE STUDY
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahendrakar Suhas |
| Designation |
postgraduate junior resident,Orthopaedics |
| Affiliation |
AIIMS Raipur |
| Address |
Mens Resident hostel
Tatibandh
AIIMS Raipur
Raipur
CHHATTISGARH
492009
India |
| Phone |
9133534683 |
| Fax |
|
| Email |
suhasmahendrakar797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Harshal Suhas Sakle |
| Designation |
Additional Professor,depatment of orthopaedics,AIIMS Raipur |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Orthopaedics
AIIMS Raipur
Tatibandh
Raipur,Chattisgarh
Raipur
CHHATTISGARH
492009
India |
| Phone |
8518881731 |
| Fax |
|
| Email |
harshal2082@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahendrakar Suhas |
| Designation |
postgraduate junior resident,Orthopaedics |
| Affiliation |
AIIMS Raipur |
| Address |
Mens Resident hostel
Tatibandh
AIIMS Raipur
CHHATTISGARH
492009
India |
| Phone |
9133534683 |
| Fax |
|
| Email |
suhasmahendrakar797@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Raipur
Great Eastern Road
opposite gurudwara
tatibandh
Raipur |
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
AIIMS Raipur
great eastern road
opposite gurudwara
tatibandh
raipur
chattisgarh |
| Type of Sponsor |
Government funding agency |
|
|
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 Mahendrakar Suhas |
AIIMS,Raipur |
Department of Orthopaedics
AIIMS Raipur
tatibandh
Raipur,C.G
PIN code-492099
Raipur
CHHATTISGARH |
9133534683
suhasmahendrakar797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
evaluation of functional and radiological outcomes of supracutaneous plating in the treatment of open tibia fractures |
intervention is the use of supractaneous plating in the treatment of open tibia fractures for a period of 18 months 6 months for recruitment and 12 months of followup |
| Comparator Agent |
evaluation of functional and radiological outcomes of use of external fixator in the treatment of open tibia fractures |
use of external fixator as a treatment modality in open tibia fracture and comparision of pros and cons of use of supracutaneous plating vs external fixator in open tibia fractures for a period of 18 months 6 months for recruitment and 12 months of followup |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
All cases will be selected on basis of:
Radiological findings confirming open tibia fracture according to Gustilo Anderson classification type 1,2,3(A,B,C) and Tscherne classification grade 1,2,3
Patients more than 18 years of age
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
Patients who are not willing for surgery
H/o old surgery or fracture in the same limb
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
For open tibia fracture supracutaneous plating is expected to be superior to conventional external fixator in respect with
Lesser chances of post operative infection
Better fracture reduction.
Higher chances of union.
Lesser incidence and lesser degree of ankle stiffness
Better LEFS and RUST scores.
|
2weeks,4weeks,6weeks,12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY- To assess the intra & post op complications in these procedures
-To classify open fractures according to Gustilo Anderson & Tscherne classification
|
2weeks,4weeks,6weeks,12weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2024 |
| Date of Study Completion (India) |
09/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
JUSTIFICATION:-External fixation plays a huge role in the treatment of open fractures .this can be used as a temporary method of fixation andor stabilization of the bone until adequate soft tissue coverage is available for definitive management or they by themselves serve as a definitive method of union of the fracture however this external fixation have their own set of complications such as high rates of infection , higher chances of nonunion specially when bone loss is present in c/o open fractures, higher chances of progression to amputation in the future, pin tract infection, stiffness of the joints, difficulty in mobilization of the patient due to the bulky nature of the external fixator.In the background of the above mentioned complications this study aims at comparing the role of external fixator versus supracutaneous plating in open tibia fractures in Indian patients especially in the state of Chhattisgarh in our setup. This study helps us to compare whether supracutaneous plating is better or same or worse than external fixator in treating open tibia fracture in terms of functional and radiological outcomes. |