| CTRI Number |
CTRI/2025/10/096607 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand recovery after surgery for shoulder fractures using newer generation humerus nails. |
|
Scientific Title of Study
|
Functional and radiological outcomes of 3 and 4 part proximal humerus fractures treated with Multiloc nail. A retrospective-prospective study with minimum 2 year follow up. |
| 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 Shailesh Pai |
| Designation |
Senior Consultant |
| Affiliation |
Tejasvini Hospital SSIOT |
| Address |
Department of Orthopaedics,
Research wing,
5th floor,
Tejasvini Hospital (Main block)
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
08242880100 |
| Fax |
|
| Email |
skpai2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohamed Faheem Kotekar |
| Designation |
Senior Consultant |
| Affiliation |
Tejasvini Hospital SSIOT |
| Address |
Department of Orthopaedics,
Research wing,
5th floor,
Tejasvini Hospital (Main block)
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
08242880100 |
| Fax |
|
| Email |
mohamed.faheem20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Pai |
| Designation |
Senior Consultant |
| Affiliation |
Tejasvini Hospital SSIOT |
| Address |
Department of Orthopaedics,
Research wing,
5th floor,
Tejasvini Hospital (Main block)
Mangalore
KARNATAKA
575003
India |
| Phone |
08242880100 |
| Fax |
|
| Email |
skpai2002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tejasvini Hospital |
| Address |
Kadri Temple Road
Mangalore |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sowmya Bhat |
Tejasvini Hospital |
Department of Orthopaedics,
Research wing,
5th floor,
Tejasvini Hospital (Main block)
Mangalore
Dakshina Kannada
KARNATAKA |
8431870394
sowmyabhat.bhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NITTE KS HEGDE MEDICAL ACADEMY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
minimum 2 years follow up |
|
| ExclusionCriteria |
| Details |
two part fracture
pathological fracture
prior surgery on same shoulder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| functional outcome - modified constant score |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications |
2 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/11/2025 |
| 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="0"
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
|
All the patients who underwent surgery for 3 and 4 part fracture proximal humerus and treated with a Multiloc nail will be telephoned and asked to come for review. Their functional and radiological outcomes will be gathered and data analysed. Complications if any will be noted too. |