| CTRI Number |
CTRI/2026/03/106422 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two surgical methods, plating and intramedullary nailing, for treatment of fracture of the upper arm bone |
|
Scientific Title of Study
|
Clinical And Radiological Outcomes Of Plating Versus Intramedullary Nailing 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 |
Dr Ananth Rao K |
| Designation |
Orthopaedic resident |
| Affiliation |
Sri Devraj Urs Academy of Higher Education and Research |
| Address |
271 Sri Madhwa Nilaya
Opposite to BSNL office , Near KSRTC Busstand
Harapanahalli , Vijayanagara 583131
Kolar
KARNATAKA
583131
India |
| Phone |
8105738780 |
| Fax |
|
| Email |
ananthraok97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagakumar J S |
| Designation |
HOD, Professor |
| Affiliation |
Sri Devraj Urs Academy of Higher Education and Research |
| Address |
Rmz galleria
A1102
Opposite to yelahanka police station
Ambedkar Colony, Yelahanka, Bengaluru, Karnataka
Kolar
KARNATAKA
560064
India |
| Phone |
9448543804 |
| Fax |
|
| Email |
jamathinagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagakumar J S |
| Designation |
HOD, Professor |
| Affiliation |
Sri Devraj Urs Academy of Higher Education and Research |
| Address |
Rmz galleria
A1102
Opposite to yelahanka police station
Ambedkar Colony, Yelahanka, Bengaluru, Karnataka
Kolar
KARNATAKA
560064
India |
| Phone |
9448543804 |
| Fax |
|
| Email |
jamathinagi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ananth Rao K |
| Address |
Sri Devaraj Urs Academy Of Higher education and Research, Tamaka,Kolar,Karnataka, India. 563103 |
| 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 Ananth Rao K |
RLJH Hospital |
Department of Orthopaedics, SDUAHER, Tamaka, Kolar 563103
Kolar
KARNATAKA |
8105738780
ananthraok97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committe, SDUAHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S423||Fracture of shaft of humerus, (2) ICD-10 Condition: S423||Fracture of shaft of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intramedullary Nailing |
Closed or open reduction and internal fixation of humeral shaft fracture using intramedullary interlocking nail. The procedure will be performed under appropriate anesthesia using standard surgical technique. Entry point will be through the proximal humerus and fixation achieved with proximal and distal locking screws. Postoperative rehabilitation will be done as per institutional protocol ie, post op, at 6 weeks, 3 momnths and at 6 months |
| Comparator Agent |
Open Reduction and Internal Fixation with Plate (Plating) |
Open reduction and internal fixation of humeral shaft fracture using dynamic compression plate or locking compression plate through standard surgical approach. Fracture reduction will be achieved and fixation performed with appropriate screws. Postoperative rehabilitation will follow institutional protocol ie, post op, at 6 weeks, 3 momnths and at 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients aged 18 to 70 years.
2.Patients with acute, closed fractures of the humeral shaft.
3.Fractures that are eligible for surgical fixation with either plating or intramedullary nailing.
4.Patients who are medically fit for surgery under anaesthesia.
5.Patients who are willing to provide written informed consent and comply with follow-up protocol.
|
|
| ExclusionCriteria |
| Details |
1. Open fractures of the humeral shaft.
2. Pathological fractures (e.g., due to malignancy, metabolic bone disease).
3.Polytrauma patients with life-threatening injuries or fractures at multiple sites that may affect rehabilitation.
4.Fractures extending into the proximal or distal humeral metaphysis (non-diaphyseal fractures).
5.Previous surgery or implant in the same humerus.
6.Patients with poor soft tissue coverage at the fracture site.
7.Associated vascular injuries requiring repair.
8.Patients with pre-existing neurological deficits (e.g., radial nerve palsy unrelated to fracture).
9.Patients with significant comorbid conditions contraindicating surgery (e.g., severe cardiac, renal, or pulmonary disease).
10.Uncooperative patients, or those unable to give informed consent or follow up (e.g., severe cognitive impairment, psychiatric illness).
11.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the outcomes of Humeral shaft fractures treated with intramedullary nailing and Plate fixation in terms of
1. Bony Union using Radiological Scoring system
2. Functional outcome using Range of motion ,Visual analogue scale score ,Disabilities of the arm ,shoulder and hand Score
|
At post op, 6 weeks, 3 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to radiological union
Assessed using serial radiographs to determine the time required for fracture union in weeks.
Range of motion of shoulder and elbow joint
Measured using goniometer during follow up visits. |
At post op, 6 weeks, 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/04/2026 |
| 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
|
Patients will be allocated in 2 groups by randomization control trial and patients will be assessed based on the radiological union and functional outcome at post op 6 weeks ,3 months ,6 months and will compare which surgical procedure is better |