| CTRI Number |
CTRI/2024/04/066233 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| 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
|
Study to assess the functional outcome of supracondylar humerus fracture in paediatric age group fixed by different methods of pinning |
|
Scientific Title of Study
|
Comparison of crossed pinning vs lateral pinning in fixation of supracondylar humerus fracture in paediatric age group- a randomised 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 |
Dr Eswaran Mythilisri |
| Designation |
Postgraduate (MS Orthopaedics) |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, 2nd floor, SRM medical college hospital and research centre
Coimbatore
TAMIL NADU
641028
India |
| Phone |
9791125472 |
| Fax |
|
| Email |
emythilisri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rajavel |
| Designation |
Associate Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, 2nd floor, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9894716229 |
| Fax |
|
| Email |
rajavelk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Rajavel |
| Designation |
Associate Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, 2nd floor, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9894716229 |
| Fax |
|
| Email |
rajavelk@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research centre, KAttankulathur, Chennai, Tamilnadu 603203, India |
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, 2nd floor, SRM medical college hospital and research centre, Kattankkulathur, Chennai, Tamilnadu 603203, India |
| Type of Sponsor |
Private 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 Eswaran Mythilisri |
SRM medical college hospital and reseach centre |
Department of Orthopaedics, 2nd floor, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU |
9791125472
emythilisri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Students, SRM medical college hospital |
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 |
| Comparator Agent |
cross pinning |
cross pinning of paediatric supracondylar humerus fracture done in 30 minutes |
| Intervention |
lateral pinning |
lateral pinning of paediatric supracondylar humerus fracture done in 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Gartland type 2 and 3 supracondylar humerus fracture, closed fractures, age under 13 years |
|
| ExclusionCriteria |
| Details |
Gartland type 1 supracondylar humerus fracture, open and compound fractures, flexion type of fractures, age more than 13 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| baumann angle and carrying angle correction measured in elbow X-rays |
pre operative elbow xray, immediate post operative xray at day 1 after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| baumann angle and carrying angle correction measured in elbow X-rays after k wire removal |
1 month following surgery after k wire removal, at 3 and 6 months of post operative follow up |
| functional outcome measurement using Flynn criteria on follow up |
1 month following surgery after k wire removal, 3 and 6 months of post operative follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/10/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
A total of 60 patients below the age of 13 years presenting to the Department of Orthopaedics with Gartland type 2 and 3 supracondylar humerus fracture will be recruited into the study after obtaining consent from the parents. The recruited participants will be randomly allocated into group A (cross pinning) and group B (lateral pinning) and the fracture will be fixed by the respective techniques. All children will be assessed for both primary and secondary outcome after data collection. |