AIP Conference Proceedings 2092, 020032 (2019); https://doi.org/10.1063/1.5096700 2092, 020032
© 2019 Author(s).
The usability of locally-made miniplate and screw compared to the existing imported miniplate and screw
Cite as: AIP Conference Proceedings 2092, 020032 (2019); https://doi.org/10.1063/1.5096700 Published Online: 09 April 2019
Prasetyanugraheni Kreshanti, Narottama Tunjung, Abram Dionisius, Sugeng Supriadi, and Yudan Whulanza
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The Usability of Locally-Made Miniplate and Screw Compared to The Existing Imported Miniplate and Screw
Prasetyanugraheni Kreshanti
1,a), Narottama Tunjung
1, Abram Dionisius
3, Sugeng Supriadi
2,3, Yudan Whulanza
2,3,b)1Cleft and Craniofacial Center Cipto Mangunkusumo Hospital – Plastic and Reconstructive Surgery Division, Department of Surgery, Faculty of Medicine, Universitas Indonesia, Jl. Salemba Raya No. 6, Central Jakarta 10430
Indonesia
2Research Center for Biomedical Engineering, Universitas Indonesia, Kampus Baru UI, Depok, 16424, West-Java Indonesia
3Department of Mechanical Engineering, Faculty of Engineering, Universitas Indonesia, Kampus Baru UI, Depok, 16424, West-Java Indonesia
Corresponding authors: a)pras_md@yahoo.com
b)yudan@eng.ui.ac.id
Abstract. Open reduction and internal fixation using miniplate and screw is still the best treatment of displaced facial fracture with functional impairment and cosmetic deformity. However, imported miniplate and screw currently widely used are highly costly. Therefore, a locally-made miniplate and screw which is cost-efficient and has the same quality with the imported brand is introduced. This study aims to evaluate the usability of locally-made miniplate and screw in comparison with the imported miniplate and screw. Cross over experimental study was conducted with sixteen plastic surgery residents randomized to receive both locally-made and imported miniplate and screw and placed them on the inferior orbital rim of polyurethane skull model. Time to complete the placement was recorded. Each subject received questionnaire to evaluate the usability of miniplate and screw in terms of operator’s comfort, screw fit to screwdriver, plate bending, and self-taping of the screw. Subsequently, two craniofacial consultants were given scoring sheet to evaluate the stability and the adaptability of each miniplate and screw. The results showed that the usability of locally-made miniplate and screw was not inferior compared to the imported brand. Nevertheless, the self-taping feature of locally-made screw may be improved to produce better quality.
Keywords: maxillofacial, miniplate, osteosynthesis, screw
INTRODUCTION
Maxillofacial injuries are one of the most complex health problems worldwide. This type of injuries creates problems of facial fractures, which are often associated with severe morbidity, loss of function, disfigurement, and high financial cost [1-3]. Data of maxillofacial fractures across multiple centers in Indonesia shows that Cipto Mangunkusumo Hospital recorded 409 patients over 5 years period, while Dr. RD Kandou Hospital in Manado treated 156 a year of facial trauma, and Makasar had around 122 patients in a year [4,5].
The treatment goal for maxillofacial fractures is restoration of premorbid anatomy and function by means of either closed treatment or open reduction and internal fixation. Open reduction and internal fixation using miniplate
The miniplate and screw system for facial fractures that are widely used and available at Cipto Mangunkusumo Hospital are Biomet® and Osteomed®. Both brands are imported and similar in their quality. These brands, however, are high cost due to the import expenses and luxury goods additional tax.
A locally-made miniplate and screw which is cost-efficient and has the same quality with the imported brand is introduced. Locally-made miniplate and screw is a prototype of the miniplate and screw which has the same configuration and material as The Lorenz plating system midface 1.5 from Biomet. Prior to animal study, this miniplate and screw has undergone loading test, tensile test and pull out test in the Faculty of Engineering, Universitas Indonesia, to evaluate the mechanical properties of the plate. This study aims to evaluate the usability of locally-made miniplate and screw in comparison with the imported miniplate and screw as control.
TABLE 1. Characteristic of Locally-made and Imported Miniplate and Screw.
Types Material Plate Information Plate Dimension Screw Information Screw Dimension Control
group Titanium
Plate 1.5 mm Mid face System, straight,
4 holes, 0.6mm OR 1mm
17x4.0x0.6 mm Screw 1.5 Self- drilling IMF Screws
of 4mm
1.5 mm diameter, 4mm length
Locally-
made Titanium Plate 1.5 mm, straight, 4 holes,
0.56mm thick 17x4.0x0.56 mm Screw 1.5 self- drilling screw of
4.57mm
1.5 mm diameter, 4.57 mm length
METHODS
Research was conducted as a cross over experimental study comparing usability of 2 different brands of miniplate and screw using anatomical polyurethane skull model done by plastic surgery residents of Universitas Indonesia at Cleft Craniofacial Center, Cipto Mangunkusumo Hospital. Each resident performed miniplate and screw placement of each brand. The usability between the 2 brands was compared.
Each subject performed miniplate and screw placement using each of the 2 brands of miniplate and screw. The sequence of the placement was randomly assigned. After the preparation of the anatomical skull model, each subject performed placement of miniplate and screw of the 2 brands. Each subject received 1 skull model, where the locally- made miniplate was placed on one side and the imported miniplate on the other side of the zygoma.
Before the procedure started, subjects were given written and graphic instructions on how to perform placement of miniplate and screw. Subjects watched a video instruction on how the procedure is done. The video instruction displayed the craniofacial consultant performing steps of the placement of miniplate and screw [9,10].
Subjects were positioned behind the skull, then instructed to place the miniplate to the skull model. The procedure simulated the repair of zygomaticomaxillary complex fracture. The miniplates were placed on infraorbital rim. Subject performed on both sides of zygoma using the locally-made brand of miniplate and screw on 1 side, and the imported brand on the other side [11,12].
The steps were as follow:
1. Subjects were positioned behind the skull as if at the head of an operating room table.
2. Subjects were given plate bender, plate grasping/holding forceps, and screwdriver. Subjects were also provided with 1.5 mm 4-holes, and 1.5 screws of one of the brands (depending on which brand the subjects were assigned to first).
3. Subjects performed plate contouring and placed the plates on infraorbital rim and afterwards, inserted the screws.
Subjects repeated the steps using another brand of miniplate and screws on the other side of zygoma of the skull model.
FIGURE 1. The preparation of anatomical skull model and miniplate and screw placement on infraorbital rim.
After completing the procedure, the time to completion of miniplate and screw placement of each subject were recorded in minutes and seconds. The time needed to complete the task were noted for each subject and compared between the two brands used.
Subjects were also given scoring sheet to evaluate the placement of miniplate and screw. Operator’s comfort, screw fit to screwdriver, plate bending, and self-taping of the screw are the parameters that were evaluated using visual analog scale of 1-10.
We defined screw-screwdriver fit as how fit is the screwdriver to the X-drive. It was evaluated during the time of an operator pulled out the screw, attached to the screw driver, and out of the screw dial. Score 10 defined that if from the time it was pulled out to the time it was drilled to the bone, the attachment was strong and the screw did not come off, it was considered fitted. Score 1 defined that when the screw came off from the attachment since the time the screw was pulled out to the time it was drilled to the bone it was considered unfitted.
We defined plate bending as the adaptability to contour the plate to the bony surface, using plate bender. Score 10 defined that the plate was flexible and form easily without any extra effort. Score 1 defined that the plate was hard to bend and needed extra effort to adjust to the wanted contour.
We defined self-drilling or self-taping as the ability of the screw to drill or cut the bone. Score 10 was when it was easy for the operator to drill the screw into the bone. Score 1 is when it needed extra effort for the operator to drill the screw into the bone.
Afterwards, 2 craniomaxillofacial consultants as assessors evaluated the miniplate and screw which had been placed on each of the skull model. Assessors were given scoring sheets for evaluating the stability and the adaptability of the miniplate and screw. Adaptability was defined as the ability of the plate to be positioned with intimate contact and match the contour to the underlying bone model.
Data was numeric, all the score from points of evaluation group were added up. Scores for each dependent variable for each group were statistically evaluated using Wilcoxon matched-pairs signed rank test.
RESULTS
Mean (SD) time to complete the placement of locally-mademiniplate and screw was longer than control group (198.8 ± 91.7 seconds vs. 145.3 ± 93.4 seconds, p = 0.0155).
However, there were no significant difference between locally-made and control group miniplate and screw in terms of operator’s comfort (6.81 ± 1.41 vs. 7.38 ± 1.52, p=0.0737), screw fit to screwdriver (8.25 ± 1.13 vs. 8.31 ± 0.87, p=0.953), plate bending (7.69 ± 1.54 vs. 8.38 ± 0.50, p=0.1617), stability (7.63 ± 0.62 vs. 8.0 ±0.83, p=0.0625), and adaptability (8.09 ± 0.99 vs. 8.09 ± 0.82, p=0.999).
FIGURE 3. Characteristic evaluation by operators (Operator’s comfort, screw fit to screwdriver, plate bending, stability, and adaptability
In terms of self-taping, control group screw was significantly better than locally-made screw (8.69 ± 0.79 vs.
6.63 ± 1.59, p=0.0008).
UniFIX® Biomet®
FIGURE 4. Self-taping of the screw
Although the result of time to complete the placement showed that control group miniplate and screw was easier to be used, there was no statistical difference between locally-made and control group miniplate and screw in terms of operator’s comfort, screw fit to screwdriver, plate bending, stability and adaptability. The self-taping of the screw, however, was better for the imported brand.
TABLE 2. The Usability of Locally-Made Miniplate and Screw Compared to Control Group Miniplate and Screw
Parameter Locally-made
Miniplate and screw Mean (±SD)
Control Group Miniplate and screw
Mean (±SD)
P Value Time to completion 198.8 (±91.7) seconds 145.3 (±93.4) seconds 0.0155
Operator’s Comfort 6.81 (±1.41) 7.38 (±1.52) 0.0737
Screw fit to screwdriver 8.25 (±1.13) 8.31 (±0.87) 0.953
Plate Bending 7.69 (±1.54) 8.38 (±0.50) 0.1617
Self taping 6.63 (±1.59) 8.69 (±0.79) 0.0008
Stability 7.63 (±0.62) 8.0 (±0.83) 0.0625
Adaptability 8.09 (±0.99) 8.09 (±0.82) 0.9993
DISCUSSION
The use of miniplate and screw for fixation of bones in facial fractures is an integral step. The plate needs to be placed precisely between the fracture lines and on the buttresses of facial bones. Another important step is to insert the screw on each side of the fracture lines. A well-placed plate and a good screw fixation motion ensure the stability of the fracture. The aim is to have a good bone contact and the fracture appears stable [13,14].
Placement of miniplate and screw can be assessed by using several methods. Time to complete the procedure can be used as the assessment objectively [9,11]. Longer time to complete the task may indicate difficulties in placing the miniplate and screw. A visual analog scoring of the comfort during procedure is also a method of assessment [15]. The miniplate and screw may also be assessed by using a measuring tool that quantitatively assesses surgical performance reviewed by observers of craniomaxillofacial surgeons with active practices in facial trauma. In terms of placement of miniplate and screw, the work list that can be reviewed are plate contouring, plate positioning, screw fit to screw-driver, screw self drilling, and screw loosening. The performance can be done on an anatomical skull model made from rigid polyurethane foam. The result of miniplate and screw placement can also be assessed by the stability after fixation and the adaptation of miniplate to the underlying bone [9,10,15].
We defined usability as the ease of use and learnability of a tool or device to achieve quantified objectives with effectiveness, efficiency, and satisfaction. In this study, we measured usability by evaluating time to complete the placement of miniplate and screw and operator’s comfort. Other measurements were the evaluation of miniplate and
Our study results showed that there was no statistical difference between locally-made and imported miniplate and screw in terms of operator’s comfort, screw fit to screwdriver, plate bending, stability and adaptability. This showed that the locally-made titanium implants were not inferior compared to the imported implants for maxillofacial fractures fixation in terms of usability. However, the time to complete the placement of plate and screw, imported implants were faster to be placed. We postulated that the self taping characteristic of the screw caused the difference in the duration of the placement. This results corresponded with the study of the mechanical properties of the implants from the faculty of engineering, Universitas Indonesia, which described that the locally- made screw was less sharp than imported screws.
The strength of our study was that we included the objective evaluation of the usability of the implants from the time to complete the placement, as well as subjective evaluation from the users which included the characteristics such as plate bending, screw fit to screwdriver, and the self taping of the screw. We added also the evaluation from craniofacial consultants of stability and adaptability of the implants after the placement on the infraorbital rim of the skull model. The limitation of our study was the small number of subjects. A similar study with larger sample size would give definitive results.
CONCLUSION
The usability of locally-made miniplate and screw was not inferior compared to the imported brand.
Nevertheless, the self-taping feature of locally-made screw may be improved to produce better quality. This study shows promising results for further development and improvement of locally-made miniplate and screw for rigid fixation in craniomaxillofacial ostheosynthesis.
ACKNOWLEDGEMENT
The authors would like to thank Universitas Indonesia for the PITTA grant number 2563/UN2.R3.1/HKP.05.00/2018 and Indonesian Medical Education and Research Institute (IMERI) Universitas Indonesia.
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