Health Condition 1: S529- Unspecified fracture of forearm
Conditions
Interventions
Intervention1: Flexi-OH -Short Arm Immobilizer: FlexiOH® intended to immobilize the injured body parts as orthopaedic cast for external mechanical supportand Clinical Evaluation Study
Control Interve
Sponsors
JC OrthoHeal Private Limited
SMO Clinical Research I Private Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. â?¢Cast index â?¢Padding index â?¢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 Timepoint: 6-8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of any of the following complication i. Development of swelling ii. Continuous numbness iii. Increasing pain iv. Continuous discomfort v. Skin infections Timepoint: 6-8 weeks | — |
Countries
India
Contacts
Public ContactMr Shreyash Padhiyar
Guru Gobind Singh Government Hospital
Outcome results
None listed