| CTRI Number |
CTRI/2026/01/100882 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Outcomes of Intramedullary Nailing versus Plating in Humeral Shaft Fractures |
|
Scientific Title of Study
|
A Comparative Study of Functional and Radiological Outcomes of Intramedullary Nailing versus Plating in Humeral Shaft Fractures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bakshi Anushka |
| Designation |
postgraduate |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospital |
| Address |
Department of Orthopaedics Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India |
| Phone |
8340519475 |
| Fax |
|
| Email |
anushkal.bakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Sivanandan |
| Designation |
head of department orthopaedics |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospital |
| Address |
department of orthopaedics Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India |
| Phone |
9790449375 |
| Fax |
|
| Email |
sivadr1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bakshi Anushka |
| Designation |
postgraduate |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospital |
| Address |
department of orthopaedics Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India |
| Phone |
8340519475 |
| Fax |
|
| Email |
anushkal.bakshi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bakshi Anushka |
| Address |
Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem tamil nadu india 636308 |
| Type of Sponsor |
Other [self] |
|
|
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 Bakshi Anushka |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
department of orthopaedics, Vinayaka Missions Kirupananda Variyar Medical College and Hospitals ChinnaSeeragapadi Salem
Salem
TAMIL NADU |
8340519475
anushkal.bakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S423||Fracture of shaft of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 acute diaphyseal humeral shaft fracture
2 pt consenting for participation and followup
3 fracture amenable to both nailing and plating |
|
| ExclusionCriteria |
| Details |
1 Patient age less than 18 or more than 65
2 Patients with conditions compromising healing.
3 Previous humeral surgeries or pathology.
4 Pathological or metastatic fractures.
5 Patients not consenting for participation and follow up.
6 Patients medically unfit for surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
IMN will be associated with shorter operative time, lesser soft tissue trauma, lower infection rates, and faster return to function in some cases.
Plating may show better anatomical reduction, especially in complex or comminuted fractures, with slightly faster radiological union. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IMN will be associated with lower infection rates, & faster return to function in some cases.
Plating may show better anatomical reduction, especially in complex or comminuted fractures, with slightly faster radiological union in certain subgroups.
|
6 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
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
In humeral shaft fractures, two primary modalities of surgical fixation are widely practiced: intramedullary nailing (IMN) and plating (using dynamic compression or locking compression plates). Each method has distinct advantages but despite multiple studies and analyses, there is no clear consensus on the superiority of one method over the other. This study aims to compare the functional and radiological outcomes, union rates, and complication profiles between the two methods followed. |