| CTRI Number |
CTRI/2021/05/033547 [Registered on: 11/05/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of Functional Outcome Of Intramedullary Interlocking Nailing Versus
Minimally Invasive Percutaneous Plate Osteosynthesis In Distal Third
Extra-articular Fractures OF Tibia In Adult Population. |
|
Scientific Title of Study
|
A Prospective Randomized Control Study to compare The
Functional Outcome Of Intramedullary Interlocking Nailing Versus
Minimally Invasive Percutaneous Plate Osteosynthesis In Distal Third
Extra-articular Fractures OF Tibia In Adult Population.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DHANASEGARAN A |
| Designation |
POST GRADUATE |
| Affiliation |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR , PONDICHERRY. |
| Address |
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY-605102
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY-605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9789349881 |
| Fax |
|
| Email |
dineshx202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MANIVELAVAN D |
| Designation |
PROFESSOR |
| Affiliation |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY |
| Address |
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY-605102
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY-605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9789771142 |
| Fax |
|
| Email |
drmanivelavan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR AMUDHA GANESH S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY |
| Address |
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY-605102
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR ,PONDICHERRY-605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9500703243 |
| Fax |
|
| Email |
amuganselvas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr DHANASEGARAN A |
| Address |
POST GRADUATE,
DEPARTMENT OF ORTHOPAEDICS ,
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR,
PUDUCHERRY. |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
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 DHANASEGARAN A |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY. |
DEPARTMENT OF ORTHOPAEDICS
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR,
PUDUCHERRY.
Pondicherry
PONDICHERRY |
9789349881
dineshx202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
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 INTERLOCKING NAILING AND MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS IN DISTAL THIRD EXTRA-ARTICULAR FRACTURES OF TIBIA . |
PATIENTS WILL BE OPERATED BY THE ABOVE MENTIONED SURGICAL MODALITIES AND WIL BE FOLLOWED UP POST SURGICALLY AT 0,3,6 AND 12 WEEKS AND ASSESS THE FUNCTIONAL OUTCOME IN PATIENTS OPERATED WITH THE MENTIONED SURGICAL MODALITIES. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both gender more than 18 years of age who sustain closed or Compound type1(Gustilo Anderson classification) distal one third
extra-articular fractures of tibia with or without
comminution. |
|
| ExclusionCriteria |
| Details |
1. Intra-articular fractures of tibia, tibial plafond fractures,
2. Pathological fractures
3. Patients with bleeding disorders, peripheral vascular disease.
4. Patients with active infection, sepsis.
5. Patients with skeletal immaturity.
6. Patients with severe head injury.
7. Patients who sustain compound fracture tibia of grade 2 and more of Gustilo Anderson classification. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
FOOT FUNCTION INDEX SCORE
RADIOGRAPHICAL EVALUATION FOR FRACTURE UNION |
AT 0,3,6 AND 12 WEEKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OLERUD AND MOLANDER SCORE |
AT 0,3,6 AND 12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
19/05/2021 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients with distal one third extra-articular tibial fractures presenting to the Hospital, are to be selected based on the inclusion and exclusion criteria. A detailed history including name, age, sex, mode of injury and existing co-morbidities will be obtained with due consideration to the exclusion criteria. Patient will be divided and randomized into two groups by simple randomization, assigning the two planned surgical modalities to patients on an alternate number basis wherein the odd numbered and even numbered patients will receive the Nailing and Plating type of Interventional modality and Selection of modality of treatment by the proposed implants for the patients will be done on comparative technique . All patients coming under the study will be explained regarding both the methods of intervention detailedly and about the tool used for assessing the functional outcome in their own understandable language. A detailed written and informed consent will be obtained from all patients prior to intervention. Autonomy of the patients will be preserved and maintained throughout the study. . A detailed consent in Helsinki declaration will be obtained. Post operatively patient will be reviewed and assessed at 0, 3 and 6 and 12 weeks for Foot Function Index score , Olerud and Molander Score clinically and fracture union by plain radiography. |