Clinical efficacy of the radius bone plates for the fixation of radius bone fractures

INTRODUCTION

The radius, being one of the two bones that form the human ante-brachium permits the forearm and your hand to pronate, supinate, and flex.¹ Some of the most common direct, low energy trauma such as a car crash can be held accountable for radial fractures.² Around 8% to 15% of the adults report injury to the radial area. It is considered to be second to the hip fractures, which is the most common fracture bone in the elderly.³ Most accounted cases of the radius fractures are based on a fall onto an outstretched arm.⁴ The older adults with osteoporosis become very fragile and are more prone to such fractures. Medical studies have reported that even a relatively minor fall from a standing position can result in a broken wrist. Therefore, age and bone disorders play an important role in determining the cause of such injuries. It’s easy to identify the fracture in the radial area due to the immediate pain, tenderness, and swelling. Deformity or numbness in the adjoining areas (especially fingers) can also help one identify the urgency of the injury.⁵ The treatments are always considered based on the location, anatomy and dissemination of the surrounding structures. Radius fractures account for 17% of the fractures in the upper extremities treatment.⁶ There are two methods of treatment that are generally considered for radius bone fractures, i.e. operative and non-operative methods for proximal, shaft and distal radius fractures. Non-operative or non-surgical treatment involves a cast that may be used to hold the bones which are in a better position until the bone heals. If the bone is out of place, then a reduction process is carried out to align the broken bone fragments. A splint of a cast can then be applied over the aligned bones to improve the healing process. The replacement period for the casts often remains 4-6 weeks at a time, followed by an X-ray examination. Therapy sessions often help and catalyze the healing period.⁷ Operative treatment takes over when the closed reduction treatment fails to position the bone correctly. In order to prevent the healing of the fracture in a wrong alignment, surgery is performed.⁸ This generally includes incisions for access to the broken bone while protecting the arteries, tissues, tendons, etc. This method of open reduction makes use of casts, metal pins, plates, screws and sometimes external fixators, or any combination of the same.⁹ The aim of this retrospective study is to measure the safety and efficacy of the Auxein medical pvt. ltd. bone plates for fractures (2R3A1, 2R3A2.1, 2R3B1.1, 2R3B1.3) pertaining to the Radius bone.

Materials

Radius plates with screws manufactured by Auxein medical pvt. ltd. were used to treat patients with radius fractures. Implants used in treatment were made up of titanium as per ISO 5832-3 (Ti-6Al-4V ELI) and stainless steel (SS) alloy as per ISO 5832-1 (316L). Instruments and implants used were biocompatible in nature.

METHODS

This study was a retrospective study directed from July 2020 to August 2021. The data of the patients were collected from different hospitals and countries treated with a radius plate system. There were 45 total patients (39M, 6F) out of which 13 patients were treated at M.O.H. Victoria hospital (Mauritius), 12 patients were treated at Clinica El Loa SA. (Chile), 5 patients were treated at Cruz Verde Ruiz Sanchez (Mexico-Guadalajara), 1 patient was treated at Hospital De Alta Especialidad Jardines (Mexico-Guadalajara), 4 patients were treated at Sanatorio Santa Isabel (Mexico-Guadalajara), 1 patient was treated at Cruz Verde Ruiz Sanchez (México-Guadalajara), 3 patients were treated at Mayoreo (México-Guadalajara), 1 Patient was treated at Salutaris (Mexico-Guadalajara) and 5 patients were treated at Hospital Echauri (Mexico/Manzanillo). The informative data collected from all the patients after surgery includes: name, date of surgery, sex, age, implant name and fracture type according to AO fracture classification system.

Inclusion and exclusion criteria

Skeletally mature patients above 20 years and having the radius bone fracture were included in the evaluation. The subjects were excluded from the study if any of the following condition exist: below 20 years, suffering from any chronic disease, not associated with the radius fracture, abuse to drugs/alcohol, neurodegenerative disease, deviation in blood pressure, CVS disease, osteopenia and allergic history with metal can cause uncontrollable risk during fixation of plates.

Statistical analysis

Primary outcomes were measured using visual analog scale with mean, standard deviation, median minimum and maximum with 95% significance level. Visual analog scale from baseline to each visit was analysed using paired t test at 5% level of significance. All statistical analysis was performed using minitab 19.

Treatment

An imaging test was performed by a physician to see the nature of the fracture which helped to decide how much reduction (the resetting or realigning of bones) is required and choose the best way to maintain the reduction while the fracture heals. Any fracture that is unstable or has extensive fragmentation needs to be treated surgically because simple casting is less likely to keep the fracture aligned. For the surgical treatments, plates with screws of the same material are given the first choice of standard to treat fracture. The treating surgeon chooses the surgical strategy. 45 patients with distal radius fractures were reported and treated with a specific choice of implant based on the type of fracture according to AO fracture classification. Patients were treated with following implants: 2.4 mm variable angle two-column volar distal radius plate (narrow), 2.4 mm variable angle two-column volar distal radius plate (wide), 2.4 mm variable angle two-column volar distal radius plate (standard), 2.4 mm wise-lock volar column distal radius plate (Figure 1). After surgery patients were followed up for 1 month, 3 months, 6 months and 12 months to check the bone healing by radiographic examination.

RESULTS

There were forty-five patients (39M and 6F) with the age range of 27-71 years (mean 45.2 years) operated with radius plate system (Table 1). Out of 45 patients, 31.1% patients (14) were reported 2R3A1, 20% patients (9) were reported 2R3B1.1, 26.6% patients (12) were reported 2R3B1.3, 22.2% patients (10) were reported 2R3A2.1 types of fracture according to AO fracture classification (Table 2).

The surgery was initiated by an expert orthopaedic surgeon and was completed in 75 minutes. In this retrospective study, the left side of the radius had a 55.5% rate of occurrence and right side of the radius had a 44.4% rate of occurrence of fracture. According to the American Society of Anaesthesiologists (ASA), 84.4% patients (38) were classified as grade 1, indicating a normal healthy patient, while 15.5% patients (7) were classified as grade 2, indicating mild systemic disease. Patients classified as grade 3 by the American society of anesthesiologists (ASA) were not included in the study. The VAS score was used for determination of the pain intensity after the surgery by a follow up period of 1 month, 3 months, 6 months and 12 months (Figure 2).

The difference in the VAS score at every follow up was observed and continuous decline in the pain intensity shows better outcomes for radius fracture treated with radius plates (Table 3).

Initial 6 months for postoperative care patients were advised rehabilitation exercises followed by physiotherapy. Examining the progress at every follow up showed good post-operative results to the end of the first year of the follow up period. A successful surgical outcome was reported without any problems or reoperational indications. It did not contain any instances of infection, non-union, or fixture failure.

DISCUSSION

The radius plating (Auxein medical private limited) are considered to be highly effective for the operative treatment of unstable radial fractures. The plating system has generally produced an outcome based on functional and radiographic parameters. The outcomes amongst the different plating systems remain persistent. The subjective measures of the outcome can also be measured by (not limited to) VAS, Mayo wrist scores, and quick dash scores. According to the study conducted by Satake et al in which 824 patients were treated surgically. In about 7.5% patients complications was reported such as nerve palsy, tendon rupture, trigger digit and carpal tunnel syndrome.¹⁰ No such results were found in the radius plates by Auxein Medical pvt. ltd. Another study conducted by Galle et al in which consecutive series of 61 patients who sustained distal radius fractures underwent surgery and complications such as Hardware sensitivity and wrist stiffness were reported at final follow up.¹¹ No complication related to hardware was reported but 8.8% patients experienced mild pain and 4.4% patients were not satisfied by aesthetic appearance (Table 4). Retrospectively Figl et al reviewed a sample of 85 patients who underwent a surgery pertaining to the variable angle volar plating fixation for unstable fractures in the distal radius. It was found out that 75% of the patients had a maintained radial height and none of the patients had lost acceptable reduction either. This study showed better immobilization of bone union without any complication.¹² This study concluded better outreach clinical results of a fracture healed with a limited time period of immobilization with no pain as compared to our analysis. The small sample size and 12-month follow-up period were the most significant limitations of our study. Despite these limitations, the outcomes were satisfactory, just as we had anticipated before beginning this clinical study.

CONCLUSION

The use of radius plates in treating unstable distal end radius fractures is associated with excellent to good functional outcomes with minimal complications.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

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