| CTRI Number |
CTRI/2024/08/072623 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare Variable angle -olecranon plate v/s Conventional olecranon plate in Comminuted olecranon fracture |
|
Scientific Title of Study
|
Efficacy of Functional Outcome of Variable Angle - Olecranon Locking Plate versus Conventional Olecranon Locking Plate Fixation in Comminuted Olecranon Fracture - A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman Kumar Srivastava |
| Designation |
Junior Resident |
| Affiliation |
UPUMS , Saifai |
| Address |
Room number - 230
Department of Orthopaedics , 2nd floor , Old building ,Uttar pradesh university of medical sciences , Saifai , Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7007244359 |
| Fax |
|
| Email |
ak.srivastava768@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SPS GILL |
| Designation |
PROFESSOR |
| Affiliation |
UPUMS , Saifai |
| Address |
Room number - 230
Department of Orthopaedics, 2nd floor , Old building , Uttar pradesh university of medical sciences , Saifai , Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9219699590 |
| Fax |
|
| Email |
simmygill@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aman Kumar Srivastava |
| Designation |
Junior Resident |
| Affiliation |
UPUMS , Saifai |
| Address |
Room number- 230
Department of Orthopaedics , 2nd floor , Old building , Uttar pradesh university of medical sciences , Saifai , Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7007244359 |
| Fax |
|
| Email |
ak.srivastava768@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics , Uttar Pradesh University of Medical Sciences , Saifai , Etawah |
|
|
Primary Sponsor
|
| Name |
Uttar pradesh university of medical sciences . Saifai , Etawah |
| Address |
Uttar pradesh university of medical sciences . Saifai , Etawah , Pincode 206130 |
| 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 Aman kumar Srivastava |
Uttar pradesh university of medical sciences |
Room number 230 , Department of Orthopaedics , Second floor , Old building , Uttar pradesh university of medical sciences
Etawah
UTTAR PRADESH |
7007244359
ak.srivastava768@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES , SAIFAI , ETAWAH |
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 |
Conventional olecranon locking plate |
via posterior elbow approach , plate fixation is done and follow up at 0 , 1.5, 3 , 4.5 and 6 month |
| Intervention |
Variable angle - olecranon locking plate |
via posterior elbow approach , plate fixation is done and follow up at 0 , 1.5, 3 , 4.5 and 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with Closed Comminuted olecranon fracture and Open
Comminuted olecranon fracture ( Grade 1 Gustilo Anderson ) .
2. Good joint function before elbow injury
3. Patients giving written informed consent will be taken |
|
| ExclusionCriteria |
| Details |
1. Patienyts with fractures of other parts of the elbow joint ( distal humeurs, radial head, coronoid process )
2. Patients with severe complications and inoperable
3. undisplaced fracture fragments or fragments displacement less than 2mm
4. Time of injury to operation more than 2 weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of variable angle olecranon plate and conventional olecranon plate in comminuted olecranon fracture |
outcome will be assessed at 1.5 month , 3 month , 4 month and 6 month from intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To evaluate the demographics profile of Olecranon fracture |
1.5 month , 3 month , 4 month , 6 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ak.srivastava768@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 30-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title of study is Variable Angle (VA) - Olecranon Locking Plate v/s Olecranon Locking Plate Fixation in Comminuted Olecranon Fracture – A Randomized control trial. Olecranon fractures are one of the most commonly seen orthopaedic injuries in the emergency room comprising approximately 10-20% of all upper extremity fractures with an incidence of 11.5 per 100000 population per year. (1-5) Fractures of the olecranon show bimodal age distribution with younger individuals sustaining a fracture due to high energy trauma and older individual as a result of a simple fall due to osteoporosis. Fractures of the olecranon process of the ulna typically occur as a result of direct trauma such as falling on the tip of the elbow or by indirect trauma such as falling on a partially flexed elbow with indirect forces generated by a strong sudden eccentric contraction of the triceps avulsing the olecranon. Olecranon fractures are common injuries of the upper extremity; majority Nonetheless, good results over all are to be expected after surgical management. Cost effective implant selection in orthopaedic trauma is essential in the current era of managed healthcare delivery. Both locking plates and variable angle (VA) – olecranon locking plates have been utilized in the treatment of comminuted fractures of the olecranon . Aim and Objectives: • Primary objectives - To evaluate outcome of olecranon locking plating in Comminuted Olecranon fracture . - To evaluate outcome of variable angle olecranon locking plate in Comminuted Olecranon fracture . - to compare the function outcome of Locking v/s Variable angle locking plate in Comminuted Olecranon fracture . • Secondary Objectives - To evaluate the demographics profile of Olecranon fracture Written informed consent will be taken from all potential eligible subjects, patients will be equally divided into two groups on the basis of treatment modality GROUP A :- Fixation with olecranon locking plate GROUP B :- Fixation with Variable angle (VA)- olecranon locking plate The first follow-up will be at 6 weeks (patients will be informed to follow up immediately if any problem related to the elbow surgery) and subsequent follow- ups will be done at 3 months, 4.5 months and at 6 months, . At every follow-up visit of the patient, the functional mayo elbow performance score 29 will be assessed and compared for any improvement or deterioration in the outcome .
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