| CTRI Number |
CTRI/2024/12/077971 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of deformity correction in children using reconstruction plate. |
|
Scientific Title of Study
|
Comparison of Paediatric Hip Plate System with Reconstruction Plate for Proximal Femur osteosynthesis in Children. |
| 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 Alok Sud |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical college and associated Kalawati Saran Childern hospital |
| Address |
Department of orthopaedics Lady Hardinge Medical college and associated Kalawati Saran Childern hospital Bangla sahib road Connaught Place
New Delhi
DELHI
110001
India |
| Phone |
9810218382 |
| Fax |
|
| Email |
avimukta2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Sud |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical college and associated Kalawati Saran Childern hospital |
| Address |
Department of orthopaedics Lady Hardinge Medical college and associated Kalawati Saran Childern hospital Bangla sahib road Connaught Place
New Delhi
DELHI
110001
India |
| Phone |
9810218382 |
| Fax |
|
| Email |
avimukta2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Gupta |
| Designation |
Associate professor |
| Affiliation |
Lady Hardinge Medical College and Associated Kalawati Saran Childrens Hospital |
| Address |
Department of orthopaedics Lady Hardinge Medical college and associated Kalawati Saran Childern hospital Bangla sahib road Connaught Place
New Delhi
DELHI
110001
India |
| Phone |
9899750676 |
| Fax |
|
| Email |
docsumitgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Plot No. 168-169-170, Phase-IV, Sector-57, Kundli, HSIIDC, Industrial Area, Sonipat, Haryana 131028 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sumit Gupta |
Lady Hardinge Medical College & Associated Kalawati Saran Childrens Hospital |
Room no -210, Bangla Sahib Rd, DIZ Area, CP
New Delhi
DELHI |
9899750676
docsumitgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LHMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q724||Longitudinal reduction defect of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hip Plate system |
Follow up will be done for 12 months |
| Intervention |
Reconstruction Plate |
Follow up will be done for 12 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children presenting to orthopaedic OPD for Pediatric hip affection requiring osteosynthesis of proximal femur. |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic infection.
2. Acute infection.
3. Patient with pathological fracture of proximal femur. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who received immobilization after Osteosynthesis of proximal femur with Paediatric Hip Plate System Versus Re-Construction Plate will be calculated. |
6 week, 3 month, 6 month, and 12 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time of bone union from post-operative radiograph will be noted in both the groups.
2. Complication related to implant as Implant failure, Implant Loosening, Infection related to implant and Neurovascular deficit will be recorded in both the groups.
3. Preoperative LEFS score and LEFS score after 12 months of surgery will be compared in all patients of both the groups. |
6 week, 3 month, 6 month, and 12 month. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
23/12/2024 |
| 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="2"
Months="0"
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
|
This is a randomized study done to compare the proportion of patients who received immobilization after proximal femur osteosynthesis with Paediatric Hip Plate System compared to Re-Construction Plate in children aged between 2 to 17 years. This is one year follow up study.
|