|Year : 2016 | Volume
| Issue : 4 | Page : 170-176
Classification of ankle injury on radiography and magnetic resonance imaging: study protocol for a retrospective, self-controlled, clinical trial with 3-month follow-up
Guo-bin Liu, Guo-ping Zhang, Qing-yun Ren, Li-cun Lei, Feng Zhao, Hong-yang Gao, Chao-hua Zhu, Ya-guang Li
First Hospital, Hebei Medical University, Shijiazhuang, Hebei Province, China
|Date of Web Publication||30-Nov-2016|
First Hospital, Hebei Medical University, Shijiazhuang, Hebei Province
Source of Support: This study was supported by the Key Technology Research Program of Hebei Provincial Health and Family Planning Commission in 2015, No. 20150615., Conflict of Interest: None
Background: Radiography is commonly used for investigating ankle injury, but is inadequate for diagnosing some ankle fractures and ligamentous injuries. Thus, radiography cannot be used for accurate fracture classification or to formulate a treatment program. In contrast, magnetic resonance imaging can clearly show occult ankle fractures and ligamentous injuries, and can diagnose fracture combined with ligamentous injury. Therefore, radiography combined with magnetic resonance imaging may potentially be adequate for fracture classification and postoperative evaluation.
Methods/Design: We conducted a retrospective, single-center, self-controlled, clinical trial with 3-month follow-up at the First Hospital, Hebei Medical University, China. Sixty-eight patients with ankle injury received internal fixation for fracture and ligament repair. The site of fractures was determined using radiography plus magnetic resonance imaging. Ankle fractures were categorized preoperatively using the Lauge-Hansen classification. We then defined imaging evaluation criteria, which were used to assess ankle fractures postoperatively. The primary outcome was the percentage of patients with an excellent outcome according to the evaluation criteria at postoperative 3 months. The secondary outcomes were the preoperative Lauge-Hansen classification; fracture repair as evaluated by radiography plus magnetic resonance imaging preoperatively and 3 months postoperatively. Other outcome was incidence of adverse events at postoperative 3 months. Results demonstrated that 53% of patients had an excellent outcome according to the evaluation criteria at postoperative 3 months. The numbers of patients with excellent, good and poor outcomes were 36, 23 and 9, respectively. In accordance with the Lauge-Hansen classification, there were 7 cases of pronation-abduction, 14 cases of pronation-external rotation (pronation-eversion), 13 cases of supination-adduction, and 35 cases of supination-external rotation (supination-eversion). The incidence of adverse events at postoperative 3 months was 17%.
Discussion: This study analyzes the feasibility of radiography combined with magnetic resonance imaging for ankle fracture classification and postoperative evaluation to provide an accurate clinical basis for repair of ankle injury.
Trial registration: ClinicalTrials.gov identifier: NCT02964754.
Ethics: The study protocol has been conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association.
Informed consent: Written informed consent was obtained from all participants.
Keywords: clinical trials; ankle fractures; fracture classification; ligament injury; postoperative evaluation; magnetic resonance imaging; X-ray; adverse reactions; self-controlled trial
|How to cite this article:|
Liu Gb, Zhang Gp, Ren Qy, Lei Lc, Zhao F, Gao Hy, Zhu Ch, Li Yg. Classification of ankle injury on radiography and magnetic resonance imaging: study protocol for a retrospective, self-controlled, clinical trial with 3-month follow-up. Clin Trials Orthop Disord 2016;1:170-6
|How to cite this URL:|
Liu Gb, Zhang Gp, Ren Qy, Lei Lc, Zhao F, Gao Hy, Zhu Ch, Li Yg. Classification of ankle injury on radiography and magnetic resonance imaging: study protocol for a retrospective, self-controlled, clinical trial with 3-month follow-up. Clin Trials Orthop Disord [serial online] 2016 [cited 2019 Nov 18];1:170-6. Available from: http://www.clinicalto.com/text.asp?2016/1/4/170/194808
| Introduction|| |
History and current related studies
Ankle injury often results in intraarticular fracture and ligamentous rupture around the ankle joint. Appropriate early treatment can effectively help the joint repair, and reduce the incidence of serious complications. Ankle fractures are one of the common orthopedic fractures (Connors et al., 2016; Kim et al., 2016).
Radiography is a common method used for detecting ankle injury, and can determine the fracture site, type and extent. However, it is difficult to use radiography to discern some ankle fractures, bone fragments, displacement, or ligamentous injury; hence, radiography alone cannot be used to accurately classify ankle fractures or formulate a treatment program (Nicholas, 1974; Zwipp, 1991; Klaue, 2004; Nikolaides et al., 2007; Hua, 2012).
Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage injury, which is advantageous in the diagnosis of ligamentous injury after ankle fracture (Chun et al., 2015; Kim et al., 2015; Wang et al., 2015). MRI can provide accurate preoperative assessment of clinical indicators for the rational formulation of treatment programs to reduce complications (Blanke et al., 2014; Grassmann et al., 2014; Lao et al., 2014; Loriaut et al., 2015; Rammelt and Obruba, 2015; Wang et al., 2015). Furthermore, the observation of ankle contusions on MRI is conducive to analyzing the mechanism of ankle joint injury (Cher et al., 2016; Delco et al., 2016; Yasuda et al., 2016; Yeung et al., 2016).
Therefore, radiography combined with MRI could potentially accurately verify soft tissue injury associated with ankle fracture and enable surgeons to determine an effective treatment program.
The aim of this retrospective study is to verify whether radiography combined with MRI is adequate to correctly classify ankle fractures and conduct postoperative evaluation in patients with ankle fracture.
Distinguishing features from related studies
Most previous related studies have investigated the accuracy of radiography combined with MRI in the diagnosis of ankle injury, but have seldom explored postoperative evaluation. In this study, examination with both radiography and MRI was used to evaluate fracture classification and postoperative evaluation in patients with ankle fracture.
| Methods/Design|| |
A retrospective, single-center, self-controlled, clinical trial with 3-month follow-up.
The First Hospital, Hebei Medical University, Shijiazhuang, Hebei Province, China.
[Figure 1] exhibits the flow chart of the study protocol.
- Sixty-eight patients with ankle injury underwent internal fixation for ankle fracture and ligament repair. Each ankle was examined using both radiography and MRI preoperatively and 3 months postoperatively.
- The Lauge-Hansen classification and the AO-OTA (Danis-Weber) classification are commonly used to categorize ankle fractures. The Lauge-Hansen classification can fully explain the injury mechanism, and so is widely used to guide treatment. Based on preoperative Lauge-Hansen classification according to the degree of bone and ligamentous injury, repair effects were assessed using our self-made ankle fracture evaluation criteria at postoperative 3 months.
- The occurrence of adverse events and the incidence of complications were assessed.
- The recruitment of subjects was started in July 2015.
Patients of either sex and any age presenting with all of the following criteria were considered for study inclusion:
- Ankle fracture detected by radiography
- High suspicion of ankle ligamentous injury
- History of obvious trauma
- Complete clinical data
- Signed informed consent
Patients with one or more of the following conditions were excluded from this study:
- Cardiopulmonary function inadequate to tolerate anesthesia or surgery
- Open fracture of the ankle joint
- History of previous fracture of the ankle joint
The baseline information including demographic data and general disease history of the included patients is shown in [Table 1].
In accordance with our experience, we hypothesized that the percentage of patients with an excellent outcome would be 70%. Taking β = 0.1 and power = 90% with a significance level of α = 0.05, the final effective sample size of n = 66 per group was calculated using PASS 11.0 software (NSCC, MD, USA). Assuming a patient loss rate of 20%, we require 80 patients per group. After screening according to the inclusion and exclusion criteria, 68 patients were included in the trial.
Inpatients at the First Hospital of Hebei Medical University were recruited. Potential participants could contact the project manager via telephone. After providing informed consent, these potential participants were screened using the inclusion and exclusion criteria.
This is an open-label trial. Patients, physicians, and assessors were not blinded to group information and therapeutic regimen.
Internal fixation of ankle fracture and repair of ligamentous injury
Steel plate and screw fixation was used for simple fractures. In cases with lower tibiofibular separation, screw fixation was carried out at the lower tibiofibular site. In cases where the triangular ligament was damaged, non-invasive suture was used.
Anteroposterior and lateral views of the ankle were taken. Measurement: a line 5 mm below the talus body was made parallel to the articular surface of the body of the talus. The intersections of this parallel line with the medial ankle joint, external ankle joint, and the medial and lateral margins of the talus were respectively defined as points a, b, c and d ([Figure 2]). Under normal conditions, ab-cd is equal to 4 mm, with a normal range of displacement of 2-6 mm. If the value of ab-cd increases, the ankle hole becomes wide. Equal medial and horizontal spaces of the ankle joint were considered as the standard. A widened medial gap was taken to indicate a lateral shift of the talus or lower tibiofibular separation.
|Figure 2: Schematic drawing showing measurement of ankle hole width.|
Note: Line D is the line parallel to the articular surface of the talus body at 5 mm below the talus body. This line intersects with the medial ankle joint, external ankle joint, and the medial and lateral margins of the talus at points a, b, c and d, respectively.
Click here to view
All patients underwent preoperative MRI. During MRI, the ankle joint was fixed in the dorsiflexion and neutral position with a brace, and scanned in the axial, coronal and sagittal planes with 45° bevel. All images were independently analyzed by an imaging expert.
Primary outcome measure
- Percentage of patients with an excellent outcome at postoperative 3 months: a higher value indicates better repair effect. Evaluation criteria: (1) Excellent outcome was defined as no internal and external displacement of the lateral malleolus and medial malleolus. Anterior and posterior displacement of the lateral malleolus, and overlapping anterior and posterior displacement of the medial malleolus of less than 2 mm. Posterior ankle displacement of less than 2 mm. Normal-sized medial malleolus hole space. Tibiofibular space of 2.5-4.0 mm. (2) Good outcome was defined as internal and external displacement of the lateral malleolus of less than 2 mm, and anterior and posterior displacement of 2-5 mm. No internal and external displacement of the medial malleolus. Overlapping anterior and posterior displacement of the medial malleolus of 2-5 mm. Posterior ankle displacement of 2-5 mm. Medial malleolus hole widened by less than 2 mm. Tibiofibular space of 4-6 mm. (3) Poor outcome was defined as internal and external displacement of the lateral malleolus of more than 2 mm, and anterior and posterior displacement of more than 5 mm. Internal and external displacement of the medial malleolus accompanied by angulation or rotation. Overlapping anterior and posterior displacement of the medial malleolus of more than 5 mm, and posterior ankle displacement of more than 5 mm, accompanied by posterior dislocation of the talus. Medial malleolus hole widened by more than 2 mm. Tibiofibular space of more than 6 mm.
Secondary outcome measures
- Lauge-Hansen classification according to the degree of bone and ligamentous injury. (1) Supination-eversion: degree I (anterior inferior tibiofibular ligament tear), degree II (degree I tear plus an obliquely-shaped inferior tibiofibular joint or spiral fracture), degree III (degree II injury plus a posterior malleolus fracture or inferior tibiofibular ligament tear), degree IV (degree III injury plus a medial malleolus fracture or triangular ligament tear). (2) Pronation-eversion: degree I (transverse fracture of the medial malleolus or triangular ligament tear), degree II (degree I injury plus anterior inferior tibiofibular ligament injury), degree III (degree II injury plus spiral fracture above the lateral malleolus), degree IV (degree III injury plus posterior inferior tibiofibular ligament injury). (3) Supination-adduction: degree I (avulsion fracture of the lateral malleolus or lateral collateral ligament injury), degree II (degree I injury plus medial malleolus fracture). (4) Pronation-abduction: degree I (medial malleolus fracture or triangular ligament tear), degree II (degree I injury plus inferior tibiofibular ligament injury), degree III (degree II injury plus lateral malleolus fracture or short oblique fracture at the distal end of the fibula above the tibial astragaloid joint).
- Radiography and MRI evaluation preoperatively and 3 months postoperatively
Other outcome measure
- Incidence of adverse events at postoperative 3 months to evaluate the occurrence of complicationss
The schedule of outcome measurement assessments is shown in [Table 2].
We recorded adverse events, including incision pain, incision nonunion, ankle pain, peripheral nerve injury of the ankle joint, ankle joint inflammation, and soft tissue injury. Severe adverse events were defined as events occurring during the clinical trial period that required rehospitalization, prolonged hospitalization, caused disability or inability to work, and/or were life-threatening or fatal. If severe adverse events occurred, investigators reported details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis and open-access
Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected.
Data were processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically. All data regarding this trial were preserved by the First Hospital, Hebei Medical University, China.
The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.
Anonymized trial data will be published at www.figshare.com .
Trial progression will be reported to the ethics committee, and the trial status will be updated in the registration database.
Trial outcomes will be transcribed, dated, and uploaded to a dedicated computer by two staff members. Data will be scheduled, checked and locked by an investigator.
The data will be password-protected, and not altered in future. Only authorized researchers will be able to access the data.
Data regarding this trial protocol will be preserved by the First Hospital, Hebei Medical University, China.
| Trial Status|| |
Study participants were enrolled from July 2015 to August 2016. Results of 3-month follow-up are as follows:
Type of ankle fracture assessed by radiography and MRI
Radiography showed that among the 68 patients with ankle fracture, 30 had left ankle fracture and 38 had right ankle fracture; 36 patients had medial malleolus fracture, 45 had lateral malleolus fracture, and 8 had posterior ankle fracture; 16 patients had fracture at 2 or 3 sites. The fracture line was clear ([Figure 3]).
|Figure 3: Fracture line at the ankle joint shown on a radiograph.|
Note: The fracture line is clear in this patient, who was diagnosed in the First Hospital, Hebei Medical University, China in September 2015.
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MRI showed that among the 68 patients with ankle fracture, there were 59 cases of ligamentous injury, with a detection rate of 87%. The fracture line was not visible on MRI in 32 patients. Fracture, bleeding and edema were seen on MRI in 36 patients.
In accordance with the Lauge-Hansen classification, there were 7 cases of pronation-abduction, 14 cases of pronation-eversion, 13 cases of supination-adduction, and 35 cases of supination-eversion ([Table 3]).
|Table 3: Lauge-Hansen classification in patients with ankle fractures (n)|
Click here to view
Postoperative 3 months follow-up evaluation of patients with ankle fractures
Thirty-six patients (53%) had an excellent outcome. Of these, none had internal and external displacement of the lateral malleolus, and 10 patients had anterior and posterior displacement of the lateral malleolus of less than 2 mm. None of the patients with excellent outcome had internal and external displacement of the medial malleolus, and there were seven patients with overlapping anterior and posterior displacement of the medial malleolus of less than 2 mm. Thirteen patients had posterior ankle displacement of less than 2 mm. The medial malleolus hole space was normal in four patients. The tibiofibular space was 2.5-4.0 mm in two patients ([Table 4]).
Twenty-three patients had a good outcome. None of these cases had internal and external displacement of the lateral malleolus, and seven patients had anterior and posterior displacement of the lateral malleolus of less than 2 mm. None of these patients had internal and external displacement of the medial malleolus, and nine patients had overlapping anterior and posterior displacement of the medial malleolus of less than 2 mm. The medial malleolus hole space was normal in four patients. The tibiofibular space was 2.5-4.0 mm in three patients ([Table 4]).
Nine patients had a poor outcome. Of these, six patients had lateral malleolus, medial malleolus or posterior ankle spaces of more than 2 mm. The tibiofibular space was more than 6 mm in three patients ([Table 4]).
Among 36 patients, the articular cartilage was obviously injured in four patients, and the joint was not fully reset in two patients. The incidence of adverse events was 17%.
| Discussion|| |
Significance of this study
This study aimed to investigate fracture classification and postoperative evaluation in patients with ankle injury using radiography combined with MRI, which is essential for developing an optimal repair plan. Radiographic examination combined with MRI can accurately classify ankle injury, provide accurate information for planning the surgical program, and provide an important reference to develop new treatment standards.
Evidence for contribution to future studies
Radiographic examination combined with MRI is used to monitor the healing process of ligaments around the ankle joint after surgical repair, enables accurate fracture classification and postoperative evaluation, and can effectively reduce the misdiagnosis rate of ankle joint injury. Our results can be used for accurate preoperative positioning, qualification, and surgical guidance, to avoid inadequate treatment and overtreatment. Postoperative dynamic observation of the healing process and timely guidance of functional exercise can effectively prevent ligament re-rupture and ankle stiffness.
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Declaration of patient consent
The authors certified that they obtained all appropriate patient consent forms. In the form the patient(s) gave his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understood that their names and initials would not be published and due efforts would be made to conceal their identity, but anonymity could not be guaranteed.
Conflicts of interest
GBL conceived and designed the trial, wrote the manuscript. Other authors assisted in trial conduction. All authors approved the final version of this paper.
This paper was screened twice using CrossCheck to verify originality before publication.
This paper was double-blinded and stringently reviewed by international expert reviewers.
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]