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CTRI Number  CTRI/2021/09/036387 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 03/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   FlexiOH® as Definitive Cast for Immobilization of Forearm Fracture. 
Scientific Title of Study   A Prospective, Open-label, Randomized, Clinical Trial of Light Cured Limb Orthosis - FlexiOH® as Definitive Cast for Immobilization of Forearm Fractures in Emergency Settings 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
OH/SMO/01/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay Sata 
Designation  Professor 
Affiliation  Guru Gobind Singh Government Hospital 
Address  Pandit Nehru Marg Indradeep Society Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427775057  
Fax    
Email  drvijayedu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Sata 
Designation  Professor 
Affiliation  Guru Gobind Singh Government Hospital 
Address  Pandit Nehru Marg Indradeep Society Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427775057  
Fax    
Email  drvijayedu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Shreyash Padhiyar 
Designation  Clinical Research Manager 
Affiliation  JC Orthoheal Private Limited 
Address  GF 33/34 Classic towers near Akota Garden Akota Vadodara

Vadodara
GUJARAT
390020
India 
Phone  9825644681  
Fax    
Email  shreyash@orthoheal.com  
 
Source of Monetary or Material Support  
JC OrthoHeal Private Limited 
 
Primary Sponsor  
Name  JC OrthoHeal Private Limited 
Address  GF 33/34,Classic Towers Near Akota Garden Akota Vadodara-390020 Gujarat India  
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
SMO Clinical Research I Private Limited  #461 ,11th main ,RMV Extension,SadaShiva Nagar Bangalore-560080 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chirag Thakkar  GMERS Medical College and Hospital   Department of Orthopedics, Old TB hospital Campus, Gotri Rd, Gotri, Vadodara, Gujarat 390021
Vadodara
GUJARAT 		 8320311258

cvtortho@gmail.com 
Dr Vilas B N  HCN Speciality Clinic & Diagnostics  HCN Speciality Clinic & Diagnostics 348, 38th Cross Rd, Jayanagara T Block, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560069
Bangalore
KARNATAKA 		 9972177211

vilas.orthopaedics@gmail.com 
Dr Karthik Vishwanathan  Parul Sevashram Hospital  Department of Orthopedics P.O. Limda Tal Waghodia Vadodara Gujarat - 391760
Vadodara
GUJARAT 		 9662088564

karthik.vishwanathan@paruluniversity.ac.in 
Dr Kiran Kalaiah  Sri Siddhartha Medical College and Hospital Tumkur  Department of Orthopedics B.H Road Agalkote Tumkur Karnataka- 572107
Tumkur
KARNATAKA 		 8162278867

dr.kirankalaiah@gmail.com 
Dr Srinivasalu S  St. Johns Medical College Hospital  Department of Orthopedics, Sarjapur Road, Bangalore - 560034, Karnataka, India
Bangalore
KARNATAKA 		 9845021315

drsrinivasalu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
CLINICOM Bangalore  Approved 
Institutional Ethics Committee for Human Research-PU-IECHR  Approved 
Institutional Ethics Committee-SSMC Tumkur  Approved 
Institutional Human Ethics Committee  Approved 
St. Johns Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S529||Unspecified fracture of forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fibreglass  Fiberglass is made up of glass fiber bandage impregnated with resin which activated by immersion in to water. Compared to POP, Fiberglass is light weight and having more strength. As current scenario Fiberglass is preferred over POP because of light weight and better strength however, it is difficult to mold, and difficult to cut. Because padding material is moisture sensitive, it’s not washable.  
Intervention  Flexi-OH -Short Arm Immobilizer  FlexiOH® intended to immobilize the injured body parts as orthopaedic cast for external mechanical supportand Clinical Evaluation Study 
Comparator Agent  POP  Plaster of Paris (POP) is a current standard and low-cost therapy option for treatment of closed reduction and immobilization of bone fracture 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Male or female aged 18 to 80 years (both inclusive)
2.Subjects with closed fracture of distal end of radius and/or Ulna not requiring internal or external fixation of the fracture belonging to following AO classification:
AO CLASSIFICATIONS
Distal radius
i.Extraarticular
ii.2R3A1 Radial styloid avulsion
iii.2R3A2 Simple
Distal Ulnar fracture
i.2U3A1 Styloid process
ii.2U3A2 Simple
3.Radiological features following above AO classification
4.Subjects able to provide written informed consent
5.Subjects able to comply with the study procedures

 
 
ExclusionCriteria 
Details  1.Presence of wound involving deeper tissues or requiring suturing
2.Ulceration or any skin conditions present at the wrist that may interfere with the study
3.Open wound along with fracture or fracture requiring internal fixation
4.Subjects scheduled for surgical management
5.Patients with other co morbid conditions, such as, osteomyelitis, severe dementia, or rheumatoid arthritis
6.Known skin allergy and skin diseases
7.Mentally challenged patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Average time required for the fracture to heal completely in all the arms at the end of treatment determined by X-rays.
a.X-ray features to diagnose /conclude that bone fracture has been healed.
2.Comparison of all three arms with respect to indices.i.e.

•Cast index
•Padding index
•Gap index
3.Assessment of clinical efficacy scoring obtained by list of questionnaires compared between FlexiOH®, Fiberglass and POP.
4.Assessment of usability scoring compared between FlexiOH® Fiberglass and POP
 		 6-8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of any of the following complication
i. Development of swelling
ii. Continuous numbness
iii. Increasing pain
iv. Continuous discomfort
v. Skin infections
 		 6-8 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   13/09/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The Clinical Investigation is intended to evaluate the efficacy and suitability of the device FlexiOH® in patients taking cast immobilization therapy for non-operative treatment of fracture lower end radius and/or ulna in comparison with POP and fibreglass and also evaluate the usability of device based on design characteristics with compared to current standard and safety issues associated with the use of the device FlexiOH®.

The clinical study will be conducted at 5 sites across India. Upto 300 subjects will be enrolled in the study.Enrolment in the study is expected to take approximately 4 months. The total Duration of clinical investigation is expected to be approximately 12 months.

 

 
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