FlexiOH® as Definitive Cast for Immobilization of Forearm Fracture.

Recruiting

• Conditions: Unspecified fracture of forearm,

• Registration Number: CTRI/2021/09/036387
• Lead Sponsor: JC OrthoHeal Private Limited

Brief Summary

**TheClinical Investigation is intended to evaluate** **the efficacy and suitability of thedevice FlexiOH****®** **inpatients taking cast immobilization therapy for non-operative treatment offracture lower end radius and/or ulna in comparison with POP and fibreglass andalso evaluate the usability of device based on design characteristics withcompared to current standard and safety issues associated with the use of thedevice FlexiOH****®.**

**The clinical study will be conducted at 5 sites acrossIndia. Upto 300 subjects will be enrolled in the study.Enrolment in the studyis expected to take approximately 4 months. The total Duration of clinical investigationis expected to be approximately 12 months.**

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-13
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Average time required for the fracture to heal completely in all the arms at the end of treatment determined by X-rays.	6-8 weeks
a.X-ray features to diagnose /conclude that bone fracture has been healed.	6-8 weeks
3.Assessment of clinical efficacy scoring obtained by list of questionnaires compared between FlexiOH®, Fiberglass and POP.	6-8 weeks
2.Comparison of all three arms with respect to indices.i.e.	6-8 weeks
•Cast index	6-8 weeks
•Gap index	6-8 weeks
4.Assessment of usability scoring compared between FlexiOH® Fiberglass and POP	6-8 weeks
•Padding index	6-8 weeks

Secondary Outcome Measures

Name	Time	Method
1.Incidence of any of the following complication	i.Development of swelling

Trial Locations

Locations (5)

GMERS Medical College and Hospital; 🇮🇳 Vadodara, GUJARAT, India

HCN Speciality Clinic & Diagnostics; 🇮🇳 Bangalore, KARNATAKA, India

Parul Sevashram Hospital; 🇮🇳 Vadodara, GUJARAT, India

Sri Siddhartha Medical College and Hospital Tumkur; 🇮🇳 Tumkur, KARNATAKA, India

St. Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

GMERS Medical College and Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Chirag Thakkar

Principal investigator

8320311258

cvtortho@gmail.com