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The Comparison Between 3.5- and 4.5-mm T-plates for Management of the Patients with Schatzker Type II Tibial Plateau Fractures that Referred to our Emergency Department: A Clinical Trial
Mohammad Parhamfar1, Ghasem Mohammadsharifi1, Amirmohammad Taravati1, Saeed Hatami1, Amirhossein Sadeghian2, Mostafa Khashei1, Mohammad M Najafi1, Ali Sherafati Chaleshtori1
1 Department of Orthopedic Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
2 Department of Orthopedic Surgery, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran
| Date of Submission | 03-Feb-2023 |
| Date of Acceptance | 04-Jul-2023 |
| Date of Web Publication | 31-Aug-2023 |
Correspondence Address:
Ali Sherafati Chaleshtori
Department of Orthopedic Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan
Iran
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/abr.abr_40_23
Background: Tibial plateau fractures have become more frequent in recent years. The most prevalent Schatzker classification is type II, which is a lateral tibial plateau fracture with depression. Our null hypothesis was that the 3.5 T-plate and the 4.5 T-plate have no difference in the management of patients with Schatzker type II tibial plateau fractures.
Materials and Methods: The current study is a clinical trial that was conducted on patients with tibial plateau fractures. The Knee Society Score (KSS) was this study's main outcome. Tourniquet time (TT) and patient quality of life using the 36-item Short Form Survey Instrument (SF-36) were secondary goals of the outcomes measurement study. VAS measured pain. Among 176 patients, 89 and 87 of cases underwent surgical treatment with 3.5-mm (group A) and 4.5-mm (group B) T-plate, respectively. The data were entered into SPSS software (version 25, IBM Corporation, Armonk, NY) and analyzed.
Results: In our study, we evaluated 176 patients with a mean age of 34.8 ± 15.2 years. Functional and clinical KSS scores were similar between the two groups throughout follow-up (P > 0.05). Regarding the other variables of VAS, TT, SF-36 physical function, and SF-36 mental health, no significant difference was observed between the two groups, and the two groups had similar averages in terms of these indicators (P > 0.05).
Conclusion: According to the results, both plates had the appropriate functional outcomes in patients with split depression tibial plateau fracture.
Keywords: Bone plates, fracture, internal fixation, Schatzker classification, tibial plateau
How to cite this article:
Parhamfar M, Mohammadsharifi G, Taravati A, Hatami S, Sadeghian A, Khashei M, Najafi MM, Chaleshtori AS. The Comparison Between 3.5- and 4.5-mm T-plates for Management of the Patients with Schatzker Type II Tibial Plateau Fractures that Referred to our Emergency Department: A Clinical Trial. Adv Biomed Res 2023;12:206 |
How to cite this URL:
Parhamfar M, Mohammadsharifi G, Taravati A, Hatami S, Sadeghian A, Khashei M, Najafi MM, Chaleshtori AS. The Comparison Between 3.5- and 4.5-mm T-plates for Management of the Patients with Schatzker Type II Tibial Plateau Fractures that Referred to our Emergency Department: A Clinical Trial. Adv Biomed Res [serial online] 2023 [cited 2023 Sep 28];12:206. Available from: https://www.advbiores.net/text.asp?2023/12/1/206/384881 |
| Introduction | |  |
Fractures of the tibial plateau are intra-articular fractures characterized by varying degrees of compression, displacement, and splitting, which can impair the knee's stability and mobility. Only one percent of adult fractures are tibial plateau fractures, but that number rises to 8% in the elderly.[1] Tibial plateau fractures have become more frequent in recent years as a result of an increase in traffic accidents. According to population-based statistics, there are 10.3–13.3 tibial plateau fractures per 100,000 people annually.[2]
These fractures are the result of indirect coronal stresses as well as direct axial compression (valgus). There is a wide range of severity in the injuries sustained, from unicondylar fractures to bicondylar and comminuted fractures.[3] Additionally, even low-energy injuries such as domestic falls can cause complex tibial plateau fractures in elderly people with osteoporotic bones. As a result, treating tibial plateau fractures has proven difficult for orthopedic surgeons. The occurrence of significant soft tissue injuries complicates the therapy of high-energy tibial plateau fractures.
In modern clinical practice, the classifications according to Schatzker and the AO Foundation and Orthopaedic Trauma Association (AO/OTA) are most frequently utilized.[4] Surgeons have greatly benefited from the Schatzker classification, which categorizes tibial plateau fractures into six subtypes for easier diagnosis and treatment.[5] In terms of the Schatzker classification, lateral tibial plateau fractures with depression (type II) are the most common. Compression of the articular surface at the edge of the split fragment is the most common cause of collapse, which occurs in the majority of cases.[6] In addition to the extent of articular compression and the size and position of the split fragment, fibular head and/or neck fractures are also possible.[7]
The reduction and fixing of these lesions with the help of plate and screw structures have been the primary focus of surgical treatment for these injuries.[8] Currently, plate and screw fixation, restoration of the bone void, and elevation of the depressed articular fragment are the recommended treatments for split depression fractures of the tibial plateau. Buttress plating with lag screws has long been used to stabilize lateral split-depression tibial plateau fractures.[9] In the past decade, pre-contoured, low-profile implants with locking screw options have evolved into periarticular plates.[10] Because of the increased risk of fixing failure in osteopenic bone, locking screws were developed for use in bicondylar fractures that necessitate angular stability.[11] The use of locking plate screw constructions in partial articular tibial plateau fractures is, however, not fully supported by clinical research.
Locking plates are increasingly being utilized to treat tibial plateau fractures. The usual plate size was 4.5 mm, while some surgeons now utilize 3.5-mm locking plates.[12] These plates have been utilized effectively in the treatment of comminuted tibial plateau fractures as they are less bulky and less difficult to conform to the bone.[11] However, there are several drawbacks to using these fixation devices. Despite being pre-contoured, they are expensive, and not all of them perfectly adapt to the bone. Sometimes the shape of the plate must be changed by the surgeon in order to align it entirely with the bone, which could damage the screw's ability to lock. To achieve interfragmentary compression, the locking screws must be placed into the plate at a 90-degree angle.[13],[14]
There are limited studies that compare the use of a 3.5 and a 4.5 T-plate in the fixation of split depression tibial plateau fractures. Our null hypothesis was that the 3.5 T-plate and the 4.5 T-plate have no difference in the management of patients with Schatzker type II tibial plateau fractures.
| Materials and Methods | | |
This was a randomized, double-blind clinical trial that was conducted on patients who were candidates for CI and presented to the emergency department of Kashani Hospital in Isfahan city in 2021–2022. The study protocol was accepted by the Isfahan University of Medical Sciences Research Committee (IR.MUI.MED.REC.1400.609) and certified by the Ethics Committee (IRCT20210614051574N16).
Inclusion and exclusion criteria
The inclusion criteria for patients included in the study were age 18 and above, split depression fractures to the lateral tibial plateau (classified as Schatzker type II), willingness for treatment, and giving informed and written consent. Exclusion criteria were The age group of fewer than 18 years, Patients with multiple traumas, open fractures, pathologic fractures, or chain injuries to the affected limb, previous knee surgery, unwillingness to participate in the study, and non-referral for follow-up treatment.
Study population
The sample size of our study was measured by sample size software (https://app.sampsize.org.uk/). Based on the following inputs, the sample size of each group was determined to be 86 cases. Our inputs: Power: 0.9, significant level: 0.05, significance: 2, mean difference: 5, population standard deviation: 10, and allocation ratio: 1.
The census approach was used to enroll all patients who matched the inclusion criteria. Demographic data on patients, including age, gender, body mass index (BMI), and mechanism of fracture, were obtained. The primary result measurement of this research was the Knee Society Score (KSS). The secondary outcomes of the outcomes measurement study were tourniquet time (TT) and patient quality of life using the 36-item Short Form Survey Instrument (SF-36). Pain was also measured using the Visual Analog Scale (VAS).
Measuring tool
Expert orthopedics evaluated the following items for each patient before surgery:
The Knee Scoring System (KSS) consists of two parts: A function score (KSS-F) and a knee score, each of which can range anywhere from 0 to 100 points. During the function evaluation, the patient is given a walking distance and stair-climbing ability rating, and any time they require a walking aid, they receive a negative score. The knee score can be broken down into two subcomponents: The first is a question that evaluates the frequency and severity of pain (KSS-P) and is worth a total of 50 points (50 points indicate that there is no pain), and the second is a clinical judgment of the range of motion (ROM) and stability of the joint, which is worth a total of 50 points (50 points indicate that there is 125 degrees of motion with no active lag, no instability, and normal alignment).[15]
Pain intensity is measured using the VAS. The VAS is a 10-centimeter line with two ends that indicate no pain (zero) and the worst possible pain.[10] Place a mark on the line to indicate the patient's current level of pain.[16]
For each patient, SF-36 questionnaires were also filled out. This questionnaire is a frequently used, well-researched, self-reported health evaluation that covers eight different categories. The SF-36 questionnaire is one of the most reliable quality-of-life questionnaires available for assessing an individual's quality of life.[17]
Surgical technique
The census approach was used to enroll all patients who matched the inclusion criteria. Then, all patients were randomly divided into two groups. Both groups of patients were provided with relevant information about the procedures and potential consequences, and after obtaining informed consent, the patients underwent the procedure. Among 176 patients, 89 and 87 of cases underwent surgical treatment with a 3.5-mm (group A) and 4.5-mm (group B) T-plate, respectively.
Group A was treated with a 3.5-mm T-plate, and group B was treated with a 4.5-mm T-plate [Figure 1]. | Figure 1: Consort diagram of patients that underwent surgical treatment with 3.5-mm (group A) and 4.5-mm (group B) T-plates
Click here to view |
To reduce local swelling, the injured leg was elevated. Within a week following the injury, surgery was conducted. Antibiotics were given intravenously during surgery. Under spinal anesthesia, patients were positioned supine, and a tourniquet was administered. In each case, the surgical procedure was identical. Under the tourniquet, an anterolateral approach was made to the lateral joint. To determine whether or not a lateral meniscal tear was present, a submeniscal arthrotomy was performed. The articular surface was lifted “en masse,” and the split component of the fracture was decreased and compressed during the procedure. A provisional reduction was achieved with temporary K-wire fixation, which was then stabilized with a laterally placed plate and screws. There was no protocol regarding the dimension of the locking plate utilized. The operating surgeon chose whether to employ a 3.5-mm (group A) or 4.5-mm (group B) T-plate. To support the raised articular segments, residual bone voids were filled with bone allograft. The decrease was confirmed by intraoperative imaging before closure. Finally, the drain was removed, and the capsule and deep tissues were closed in layers after the meniscus was restored if damaged.
From the first to the second postoperative day, patients might engage in passive motion under the supervision of a physical therapist. For 6–8 weeks, the patient was only allowed to use a walker or crutches for non-weight bearing mobility. When union is seen on radiographs, full weight bearing might begin after 8–14 weeks of partial weight bearing.
Postoperative follow-up
After procedures, patients were seen on a regular basis, and the same measurements were taken at 3, 6, 12, 18, and 24 months. The collected data were analyzed.
Statistical analysis
After collecting the study data, they were entered into SPSS software (version 25, IBM Corporation, Armonk, NY) and analyzed. Results were compared using the Student's t-test with a P value and a mean value where the sample size was less and inadequate. In all tests, values of P < 0.05 were considered significant.
| Results | | |
A total of 194 patients entered this study. Twelve patients were excluded due to incomplete file information and declined to participate. Also, six patients were excluded due to improper follow-up. In this study, 176 patients, including 92 females and 84 males, with a mean age of 34.8 ± 15.2 years, were included in the study. Among patients, 89 and 87 cases were undergoing surgical treatment with a 3.5-mm (group A) and 4.5-mm (group B) T-plate, respectively.
The demographic data for the study population are shown in [Table 1], and it is evident from the table that there was no statistically significant difference between the two groups in the distribution of the variables average age, gender, side of the fracture, mechanism of trauma, and average BMI (P > 0.05).
The results of the independent t-test showed the KSS-functional score of two groups at 3, 6, 12, 18, and 24 months after surgery [Table 2]. At all times of the KSS-functional score assessment, the average score of group A was lower than group B [Figure 2]. However, there was no significant difference between the two groups (P > 0.05). Regarding the KSS-clinical score, no significant difference was observed between the two groups at any time (P > 0.05) [Table 2] and [Figure 3]. Regarding the other variables of VAS, TT, SF-36 physical function, and SF-36 mental health, no significant difference was observed between the two groups, and the two groups had similar averages in terms of these indicators. There was no fixation failure in both groups, and the quality of reduction was assessed by C-Arm dynamic radiography in the operation room and during every post-operative visit in the follow-up. We added these tips in the results part. | Table 2: Mean of the KSS score, SF-36, VAS, TT, infection, and failure of Groups A and B
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| Discussion | | |
In our study, we evaluated 176 patients with a mean age of 34.8 ± 15.2 years. According to the results, no significant differences were observed between the two groups in terms of functional and clinical KSS scores at all times of follow-up. The difference in quality of life between the two groups was not statistically significant due to the varied sizes of the plates used. Also, no cases of failure were observed in the two groups.
The most clinically frequent type of tibial plateau fracture is a split or cleavage depression fracture of the lateral plateau, which composes about 25–33% of all fractures at this location. More than 60% of tibial plateau fractures impact the lateral column because of the unique geometry of the knee and the forces at the tibiofemoral joint.[1] The split pattern is found in the majority of these fractures of the lateral tibial plateau. Some of them also relate to articular surface depression.[18]
Surgical intervention is required for deviated tibial plateau fractures. Several factors, including age, the quality of the reduction, fracture type, accompanying lesions, and implant type, appear to influence treatment outcome.[19] Although results may vary depending on the type of implant used and due to the current trend of orthopedic surgeons preferring locked implants, it is unclear whether the use of a specific type of implant affects clinical and functional outcomes.[20] In addition, there is rising concern regarding the expense of implants and their effect on the public and private health care systems. Research evaluating the effectiveness of various implants and accounting for a number of characteristics, such as pain, function, quality of life, and time away from work, is necessary to conduct cost-efficiency studies to determine whether the adoption of a given implant type is adequate.[21]
In the past, medial or lateral tibial plateau fractures were treated with T- or L-shaped 4.5-mm plates and partial-thread 6.5-mm screws to compress the articular surface. Surgeons frequently used 4.5-mm locking plates for the treatment of tibial plateau fractures in the latter part of the 1980s and early 1990s, believing that these plates increased mechanical stability.[12] Although using these novel plates to treat plateau fractures has had satisfactory results, several problems have also been noted. Krettek et al.[22] discovered that 4.5-mm plates can cause devitalization of the fracture due to a substantial muscle detached from the bone, peroneal nerve injury, and difficulty placing the plates in the lateral limiting area. These complications appear to be less common when using 3.5-mm plates, which are also easier to place at the fracture site and cause less injury to the soft tissues around the bone. In addition, 3.5-mm screws or K-wire can be utilized near the articular surface in conjunction with raft screws or wire for enhanced fragment stabilization in comminuted fractures.[23] Furthermore, the biomechanical properties of locked 3.5-mm and 4.5-mm plates are not considerably different. In cancellous bone, 3.5-mm screws have been shown to have the same pullout strength as 4.5-mm and 6.5-mm screws. Also, the articular surface can accommodate more screws due to the lower size of 3.5-mm screws, which helps support the smaller fragments.[24]
There are a number of advantages to treating proximal tibial fractures with pre-contoured anatomic plates. Two of these advantages include the reduction in the amount of time required for intraoperative plate contouring and the utilization of procedures that are less invasive. Anatomical plates made by well known manufacturers were not exactly matched to the bones of the cadaver samples, as shown by the research done by Goyal et al.,[25] in which the plates did not completely touch the bone. This was demonstrated through the use of cadavers. However, while the process is being performed, the straightforward plates measuring 3.5 millimeters in thickness may be swiftly manufactured and implanted in the bone. In some cases, the compression of fracture fragments might be facilitated by the use of screws that do not lock into place. In addition, the cost of locking plates is significantly higher than the cost of regular plates, which may create a significant financial strain on patients.
Due to the disadvantages of 4.5-mm plates (whether locking or non-locking), the challenges in contouring locking plates to the bone surface, cost-benefit analyses, and a consideration of the efficiency properties, we also compared the 3.5-mm versus 4.5-mm simple non-locking and non-pre-contoured plates for the surgical treatment of tibial plateau fractures.[26] In our study, no significant difference was observed in terms of different variables between the two groups. Bagherifard et al.[12] investigated the efficacy of employing 3.5-mm simple plates for treating varied tibial plateau fracture types. There were no problems with the kind or size of plates in any of the fracture healing processes in this investigation. The functional outcomes were positive, and the medically obtained reduction was still visible after 16 months. Even in Schatzker's type V and VI fractures, simple 3.5-mm plates were used with anterolateral and posteromedial approaches if necessary, and no fixation failures occurred. They discovered that 3.5-mm basic plates might give acceptable functional, clinical, and radiological results. One of the study's weaknesses is the lack of comparison between 3.5-mm and 4.5-mm basic plates. Despite the fact that we were able to overcome this constraint in our investigation, no significant variations in plate size were identified. In our investigation, there were two and one case of infection in groups A and B, respectively, although there were no statistically significant differences.
Our study also has some limitations. First, in our study, only one type of fracture was investigated. Second, the statistical population of our study is small, and the third limitation of our study is the lack of comparison between two groups in terms of treatment costs.
| Conclusion | | |
In our study, we investigated the stability of fixation in a split depression tibial plateau fracture (Schatzker type II) by contrasting 3.5- and 4.5-mm T- plates. According to the results, both plates had the appropriate functional outcomes in patients with split depression tibial plateau fracture. Therefore, we can use 3.5- and 4.5-mm T-plates as alternatives in such situations. However, considering the limitations that existed in our study, it is suggested that more studies be conducted with a larger statistical population.
Ethics approval and consent to participate
The patient provided written informed consent for the publication of this case report and accompanying images.
Availability of data and materials
The authors declare that data supporting the findings of this study are available within the article.
Financial support and sponsorship
This work did not receive any specific grants from funding agencies in the public, commercial, or non-profit sectors.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]
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