FlexiOHÂ® as Definitive Cast for Immobilization of Forearm Fracture.

Not Applicable

Conditions: Health Condition 1: S529- Unspecified fracture of forearm

Registration Number: CTRI/2021/09/036387

Lead Sponsor: JC OrthoHeal Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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. <br/ ><br>a.X-ray features to diagnose /conclude that bone fracture has been healed. <br/ ><br>2.Comparison of all three arms with respect to indices.i.e. <br/ ><br> <br/ ><br>â?¢Cast index <br/ ><br>â?¢Padding index <br/ ><br>â?¢Gap index <br/ ><br>3.Assessment of clinical efficacy scoring obtained by list of questionnaires compared between FlexiOHÂ®, Fiberglass and POP. <br/ ><br>4.Assessment of usability scoring compared between FlexiOHÂ® Fiberglass and POP <br/ ><br>Timepoint: 6-8 weeks

Secondary Outcome Measures

Name	Time	Method
1.Incidence of any of the following complication <br/ ><br>i.Development of swelling <br/ ><br>ii.Continuous numbness <br/ ><br>iii.Increasing pain <br/ ><br>iv.Continuous discomfort <br/ ><br>v.Skin infections <br/ ><br>Timepoint: 6-8 weeks