| CTRI Number |
CTRI/2026/01/100841 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the safety and performance of implants used for radius head replacement in patients with elbow fracture |
|
Scientific Title of Study
|
Post Market Clinical Follow-up (PMCF) study to evaluate the safety and performance of Radial Head System |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR_PMCF/P_26 Dated 25.08.2025 Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot No 157
Phase 5
Sector 56
HSIIDC Industrial Estate Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
m.aslam@auxeinmedical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot No 157
Phase 5
Sector 56
HSIIDC Industrial Estate Kundli
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
m.aslam@auxeinmedical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot No 157
Phase 5
Sector 56
HSIIDC Industrial Estate Kundli
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
m.aslam@auxeinmedical.com |
|
|
Source of Monetary or Material Support
|
| JPNA Trauma Centre, AIIMS, New Delhi |
| MAMC & LNJP Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Auxein Medical Pvt Ltd |
| Address |
Plot No 157, Phase 5
Sector 56
HSIIDC Industrial Estate Kundli, Sonipat, Haryana 131028 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samarth Mittal |
All India Institute of Medical Sciences |
Room no. 409, Department of Orthopedics, Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi-110029
South
DELHI |
9013562489
samarthmittal@gmail.com |
| Dr Sumit Arora |
Maulana Azad Medical College & LNJP Hospital |
Room No-608, Department of Orthopedics, Orthopedic Block, New Delhi
Central
DELHI |
9868329380
mamc_309@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S479||Crushing injury of shoulder and upper arm, unspecified arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
N.A. |
| Intervention |
Radial head replacement |
Radial head replacement shall be done at baseline and patients shall be followed up for two years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-reconstructible radial head fractures. |
|
| ExclusionCriteria |
| Details |
1. Patients will known metabolic bone disease.
2. Patients having inadequate tissue coverage over the operative site.
3. Suspected or documented allergy or intolerance to implant materials.
4. Patients with symptomatic arthritis.
5. Severely comminuted fractures.
6. Prominent neurological condition that would interfere with physiotherapy.
7. Known psychiatric disease that would interfere with study participation.
8. Pregnant women or those planning pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Rate of implant survivorship.
2. Complications including SAEs.
|
6 Week
3 Month
6 Month
12 Month
24 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in patient reported outcomes.
2. Range of motion. |
6 Week
3 Month
6 Month
12 Month
24 Month |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 multi-centeric prospective PMCF study. The study aims to assess the safety and
performance of Radial Head System manufactured by Auxein Medical Pvt Ltd. A total of 30 patients will be enrolled in the
study. Total duration of the study is three years. |