A total of 137 subjects from 5 different sites across India i.e., 24 subjects from the 1st centre, 21 subjects from the 2nd centre, 18 subjects from the 3rd centre, 17 subjects from 4th centre and 57 subjects from the 5th centre were involved. On the patient’s hand, the FlexiOH^® short arm immobilizer was applied using a zip and then cured using the Rizycure® light device which was recommended for the duration of 3-20 minutes based on the size of the immobilizer. (Figure 1) When it became rigid, the zip puller was cut using pliers so that the patient could not take off the immobilizer on their own.

The patients were followed, and the data were recorded at visit 1(screening visit), visit 2, and visit 3. The data recorded were the vital signs - systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, pulse rate, X-ray results, concomitant medication prescribed for the subjects during the study, and any adverse events caused during all three visits. Data was collected and entered in the predesigned Excel spreadsheet and were presented in the form of frequencies and percentages.

Figure 1

Systolic Blood pressure (SBP) of all 137 subjects were ranging from 100-142 mmHg in all the 3 visits. SBP among patients varied significantly in a few patients but was considered normal, whereas the Diastolic Blood Pressure (DSP) showed values between 60 to 92 mmHg in all three visits. The temperature and pulse rate of subjects ranged from 35 °C to 37 °C and 60 to 94 bpm, found normal throughout the study. SBP, DBP, temperature, and pulse rate showed normal throughout the study during all 3 visits.

Out of 137 (100%) subjects, wrist stiffness was reported in 27 (20.33%) subjects, followed by distal Oedema in 24 (17.5%) subjects, followed by muscular atrophy in 8(5.8%) and only 2(1.5%) patients reported skin infections during the study. These are expected AEs due to the immobilization and we report that it is very minimal compared to the conventional one. X-ray was done for Visit 1 and Visit 3 and analyzed for all the subjects. X-ray results showed that the study subjects were completely healed on the 3rd visit. FlexiOH^® (Short Arm Immobilizer) was very effective as 100% of subjects showed healing complete on the 3rd Visit (Table 1 and Figure 2) and satisfactory range of motion after removal of FlexiOH^® (Figure 3).

Figure 2

Figure 3

All 137 subjects were on concomitant medication in the first visit for pain and inflammation management. Most of the study subjects were prescribed diclofenac 95 (69.3%) in the 1st visit followed by Etoricixib in 113 (82.5%) and Paracetamol in 116 (84.7%) in the second visit and third visit respectively. We observed that at the end of the study, there was a decrease in the requirement of concomitant medication for the management of pain which is comparable to the baseline (Table 2).

Overall, in the present study, the vital signs, adverse events, and concomitant medication showed normal results with minimal adverse events. The X-ray findings showed that the fracture in all 137 subjects completely healed at 3rd visit. With these promising results, we claim that FlexiOH^® technology offers more than just reliable immobilization for uncomplicated care of fractures and sports injuries of the limbs. As a contemporary alternative to plaster and cast bandages, the flexible and slightly stretchable plastic material fits snugly around the arm and can be easily closed with the integrated zipper. After the treatment duration, the splint can be rapidly and painlessly removed by opening it up once more. FlexiOH^® is a waterproof and breathable cast that allows you to shower, swim, and carry out daily activities without damaging the cast or compromising hygiene. The waterproof feature enhances convenience and helps maintain better skin health by preventing moisture accumulation and associated problems like maceration and foul odour. The breathability of this cast also helps with air circulation, reducing the likelihood of skin irritation and providing a more comfortable healing experience.

Casting does have some risks and it is inevitable sometimes. Firstly, because of immobilization, some of the complications such as thrombosis, muscle atrophy, joint stiffness, and disuse syndrome were reported. Secondly, conventional casts have certain specific complications. The most reported ones include a limited blood supply when the cast is applied too tightly or otherwise gets too tight due to swelling, acute compartment syndrome, and compression neuropathy ¹⁵. The six P's are used to describe the first complication, acute limb ischemia: pain (typically in the distal region of an extremity), poikilothermia (sensation of cold on the skin), pallor, pulselessness, paresthesia, and paralysis ¹⁶. Due to compression neuropathy, nerve conduction is delayed and eventually completely inhibited when ischemia occurs. Weakness and pain are symptoms ¹⁷. Compartment syndrome is the third and most significant complication with the conventional cast. Compartments in the limbs are divided by strong, fascial membranes and contain muscle groups. Compartment syndrome develops when a compartment's pressure rises and compromises the circulation as well as the function of the compartment's contents ¹⁸. Pain is the most significant symptom. Compartment syndrome is associated with pain that causes a burning sensation, appears after a delay of time, aggravates more severely, or occurs when a passive stretch is applied to the compartment. Paralysis and paresthesia are other symptoms; however, they appear later.

Although the pressure in the compartment is generally lower than the systolic blood pressure, the presence of arterial pulses does not exclude the diagnosis of compartment syndrome. In addition, the tissue may appear noticeably swollen and may feel tense to palpation ¹⁹. In addition to these complications, conventional casts have some practical limitations that may affect the patient's quality of life, and these include sweating, having to carry around a lot of weight, as well as not being able to take a shower. Also, when there is a requirement for an examination or x-ray, the cast must also be entirely removed as well as changed. These difficulties can be resolved by using a short arm immobilizer device from FlexiOH^® because they are up to 50% lighter than a conventional cast, waterproof, provide aeration, and are simple to use and take off Without having to make use of any other external cast cutter/spreader, FlexiOH^® can be removed following the course of treatment. FlexiOH^® is carefully engineered using materials and a design that is meant to give the patient the best possible comfort. Foam that comes into contact with the skin is biocompatible (certified by ISO 10993-10) and offers protection from the hardened polymer. The intermittent hollow spaces in the FlexiOH® short arm immobilizer are designed to make it more convenient for air to circulate and for water or sweat to evaporate from the skin's surface. The radiolucency property of FlexiOH^® short arm cast does not interfere with the radiological imaging or diagnosis. Because of all these advantages and promising study outcomes, we recommend that surgeons utilize FlexiOH^® short arm immobilizer can be a potential solution in treating patients with distal radius fractures patients.

FlexiOH^® is a new revolutionary orthopaedic immobilization device that can be applied for both bone fractures as well as musculoskeletal injuries and offers a safe alternative over the conventional cast, which has major side effects. It is affordable and can easily be available depending on the size and variant of the cast needed. The product is the most advanced orthopaedics immobilization technology and has the potential to be used and adopted throughout the world.