A Prospective, Multicentric, Open label and Post Marketing Clinical Follow up Study to Monitor the Safety and Performance of Light Cured Limb Orthosis - FlexiOH® (Short Arm Immobilizer) in Fractures Distal Radius

Background: Distal forearm fracture is the most common fracture encountered in daily life. Patients with this type of injury suffer from meaningful pain after Emergency Department discharge. Various studies reported that short-arm, below-the-elbow casts perform as well as long-arm, above-the-elbow casts for maintaining a reduction of distal forearm fractures demonstrated with a comparable risk of complication. Consequently, short casts are the commonly used method of immobilization however, short casts carry a potential disadvantage. Objective: To evaluate the safety and efficacy of the next-generation FlexiOH® (Short Arm Immobilizer). Settings and Design: This is a prospective, multicentre, and open-label clinical trial conducted in 5 different sites in India by recruiting a total of 137 subjects who were presented with distal forearm fractures. Materials and M ethods: Vital signs, concomitant medication taken by subjects during the study, X-ray results, and adverse events caused during all three visits were evaluated. Results: Overall patients showed normal vital signs, minimal adverse events, and relatively less concomitant medication consumption during the study period and at the end of the study, 100% healing was noted among all the study participants in the X-ray investigation. This clearly demonstrates the benefits over the conventional methods. Conclusion: For uncomplicated care of fractures and sports injuries of the limbs, FlexiOH® (Short Arm Immobilizer) technology offers more than just reliable immobilization and has advantages over contemporary plaster and cast bandages. This product is the most advanced orthopaedic immobilization technology and has the potential to be used and adopted worldwide. Keywords: FlexiOH®, Distal radius fractures, Short arm immobilizer, Adverse events