| CTRI Number |
CTRI/2024/06/068504 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [slab or cast will be given in post operative period after closed reduction and percutaneous pinning ] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
study on outcome of slab vs cast application in type 3 supracondylar fracture |
|
Scientific Title of Study
|
Short-Term Functional and Radiological outcome Analysis of Cast Vs Slab Splintage in Operated Case of Type III Supracondylar Humerus Fracture- 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 |
Bhuwan Raj Aryal |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of orthoaedic surgery, Room no 15, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847311722 |
| Fax |
|
| Email |
bhu.ary9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhuwan Raj Aryal |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Orthopaedic surgery, room no 15, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847311722 |
| Fax |
|
| Email |
bhu.ary9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhuwan Raj Aryal |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Orthopaedic surgery, room no 15, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847311722 |
| Fax |
|
| Email |
bhu.ary9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Chandigarh sector 12 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER |
sector 12, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhuwan Raj Aryal |
Post Graduate Institute of Medical Education and Research |
department of Orthopaedic surgery Room no 15 Nehru buliding
Chandigarh
CHANDIGARH |
8847311722
bhu.ary9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S424||Fracture of lower end of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cast or slab application in post operative period after closed reduction and percutaneous pinning |
patient will be applied either above elbow cast or above elbow slab in post operative period after closed reduction and percutaneous pinning |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. closed fractures
2. isolated type III supracondylar humerus fractures
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to estimate and compare incidence of loss of reduction by using Baumanns angle in patient with type III supracondylar fractures treated with above elbow cast and above elbow slab in post operative period after CRPP |
3weeks and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out incidence of complications between the two groups in post operative period |
upto 3 months |
|
|
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 1 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The aim of this study is to compare the radiological and functional outcone of post operative above elbow cast vs above elbow slab splintage in operated cases of type III supracondylar humerus fractures.
null hypothesis : there is no difference in radiological and functional outcome in operated case of type III supracondylar fracture splinted in above elbow cast or slab in post-operative period.
|