| CTRI Number |
CTRI/2024/01/061657 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of wrist bone fracture union with the help of radius plates |
|
Scientific Title of Study
|
A prospective single arm post market clinical followâ€up study to evaluate the safety and performance
of radius system intended for radius fracture fixation. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samarth Mittal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 409, Department of Orthopedics, Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9013562489 |
| Fax |
|
| Email |
samarthmittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Department of Clinical Research
Auxein Medical Pvt Ltd,
Plot No. 168-169-170, Phase-IV, Sector-57, Kundli Industrial Area, HSIIDC, Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxein.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Department of Clinical Research
Auxein Medical Pvt Ltd
Plot No. 168-169-170, Phase-IV, Sector-57, Kundli Industrial Area, HSIIDC, Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxein.com |
|
|
Source of Monetary or Material Support
|
| Auxein Medical Pvt Ltd
Plot No. 168-169-170, Phase-IV, Sector-57, Kundli Industrial Area, HSIIDC, Sonipat, Haryana 131028 |
|
|
Primary Sponsor
|
| Name |
Auxein Medical Pvt Ltd |
| Address |
Plot No. 168-169-170, Phase-IV, Sector-57, Kundli Industrial Area, HSIIDC, Kundli, Sonipat, Haryana 131028 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 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 |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE All India Institute of Medical Sciences New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Radius plate system |
12 Months intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Subject or Subject legal Guardian or Parent willing and able to give informed consent for participation in the study
2 Male or Female aged between 18 to 65 years
3 Participant with confirmed diagnosis as per the indications |
|
| ExclusionCriteria |
| Details |
1 Infection local or Systemic Acute or Chronic Inflammation to the operative site
2 Severe osteopenia and or osteoporosis or in the presence of marked or rapid bone absorption metabolic bone disease cancer or any other tumor like condition of the bone which may compromise fixation Osteoporosis is a relative
contraindication since this condition may limit the degree of obtainable correction the amount of mechanical fixation
3 Insufficient skin tissue bone or neurovascular condition
4 Subjects with high activity levels diabetes high bleeding from vascular Injury
5 Blood circulation problems and blood supply impairment
6 Subject with Suspected or documented metal allergy or in tolerance
7 Psychologically or physiologically inadequate subjects
8 Severe bow or gross distortion of the radius
9 Female participant who is pregnant or planning pregnancy during the course of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Quality of bone union
2 PRWE to measure wrist pain
3 Evaluation of hand grip strength |
6 weeks, 3, 6 and 12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain evaluation through Visual Analogue Score
|
6 week 3 month 6 month 12 month |
| Assessment of complications |
6 week 3 month 6 month 12 month |
|
Target Sample Size
Modification(s)
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Fractures of the radius bone in the forearm are a common orthopedic injury, often resulting from accidents,
falls, or sports-related activities. These fractures can lead to functional impairment, pain, and decreased
quality of life for subjects. This type of fracture is particularly prevalent among individuals of all ages, from
children to older adults, due to the vulnerability of the forearm bones during activities that involve impact or
high force. Radius fractures can vary in severity, ranging from a small crack in the bone to a complete break
that causes the bone to shift out of place.
Understanding the causes, symptoms, and treatment options for radius fractures is crucial in effectively
managing and recovering from this injury. Medical intervention, including accurate diagnosis,
immobilization, and rehabilitation, plays a significant role in restoring functionality and reducing long-term
complications. To facilitate the healing process and restore proper function, medical professionals often
employ surgical interventions, with radius plates being a widely used treatment option.
Radius plates serve as an internal fixation device, providing stability and support to the fractured bone
during the healing process. These plates are typically composed of biocompatible materials, such as
titanium or stainless steel, and are designed to withstand the physiological loads placed on the radius.
This protocol outlines a comprehensive study aimed at investigating the safety and effectiveness of radius
plates for the management of radius fractures. The study will encompass a range of factors, including
subject outcomes, biomechanical analysis, and the identification of potential complications or adverse
effects associated with radius plate fixation.
The primary objective of this study will be to assess the safety of radius plates by analyzing the occurrence
of postoperative complications, such as infection, implant failure, and nerve or blood vessel damage. Long-
term follow-up will be conducted to monitor the progress of fracture healing, range of motion, grip strength,
and subject-reported outcomes, including pain levels and satisfaction with treatment.
Additionally, the effectiveness of radius plates will be evaluated by examining the rate of fracture union and
restoration of bone alignment. Radiographic analysis will be performed to assess the degree of bone
healing, alignment, and any signs of implant failure or loosening. Functional outcomes, such as wrist
motion, forearm rotation, and grip strength, will be measured and compared to preoperative values to
determine the efficacy of radius plate fixation in restoring normal function.
Furthermore, biomechanical analysis will be conducted to assess the grip strength by Jamar dynamometer.
In conclusion, this protocol outlines a comprehensive study designed to evaluate the safety and
effectiveness of radius plates for the treatment of radius fractures. |