Abstract
The goal of this meta‐analysis was to explore the overall safety and efficacy of surgical therapy vs conservative therapy for acute injury of the lateral ankle ligament based on eligible studies. Eligible studies were identified by searching PubMed, Cochrane, and Embase databases using appropriate updated index words to January 2018. We also searched relevant publication sources. Eligible studies included randomised controlled trials and comparative studies. Mean difference or relative risk (RR), along with 95% confidence interval (CI), was used to analyse the main outcomes. A total of 13 studies were eligible for this meta‐analysis, with 834 patients in the surgical therapy group and 930 patients in the conservative therapy group. Compared with patients receiving conservative treatment, patients undergoing surgical treatment had a significant higher American Orthopedic Foot And Ankle Society (AOFAS) score (weighted mean difference(WMD): 10.33, 95% CI: 6.83‐13.83) and an effective rate (RR: 1.15, 95% CI: 1.04‐1.28). No significant differences were observed in the incidence of recurrent ankle injury (RR: 1.01, 95% CI: 0.62‐1.65), limited range of motion (RR: 1.44, 95% CI: 0.83‐2.50), deep vein thrombosis (RR: 1.33, 95% CI: 0.73‐2.41), and wound infection or necrosis (RR: 3.99, 95% CI: 0.45‐35.34). However, compared with patients receiving conservative treatment, patients undergoing surgical therapy had significantly increased rates of complications (RR: 3.31, 95% CI: 2.55‐4.28), ankylosis (RR: 3.63, 95% CI: 2.16‐6.08), scare tenderness (RR: 10.16, 95% CI: 3.89‐26.52) and sensory loss (RR: 5.66, 95% CI: 2.76‐11.59). The results demonstrated that surgical treatment increased the AOFAS score and effective rate compared with conservative treatment. Besides, surgical treatment increased the rate of complications. Nevertheless, more high‐quality randomised controlled trials with a larger sample size conducted at multiple centres with a long‐term follow up are needed to confirm our conclusions.
Keywords: conservative treatment, lateral ankle ligament, meta‐analysis, surgical
1. INTRODUCTION
Acute injury of the lateral ankle ligament is one of the most common injuries related to the musculoskeletal system, accounting for nearly 25% of all injuries.1, 2, 3 If not handled correctly in the early stage, lateral ankle laxity may ensue, leading to chronic ankle instability, recurrent ankle sprain, and chronic pain, which consequently influence ankle activity and increase the risks of ankle degeneration and osteoarthritis.4, 5 The overall number of ankle injuries each day in the United States and United Kingdom is about 23 000 and 5000, respectively. It has been reported that 600 000 patients suffer from ankle injury with each passing day, of whom approximately 120 000 patients present with sporting injuries. Moreover, nearly 43 000 patients present for medical care.6, 7, 8, 9 About 125 000 patients in the Netherlands with a ankle sprain seek treatment by general practitioners every year, with an incidence of 8 per 1000 patients annually. For acute injury of the lateral ankle ligament, the treatment methods include suture, plaster fixation, elastic bandage, ankle support, ligament reconstruction, functional treatment, anchor repair, and so on. In this meta‐analysis, moderate to strong evidence was collected to explore the safety and efficacy of surgical treatment vs conservative treatment for acute injury of the lateral ankle ligament based on eligible studies.
2. METHODS
2.1. Search strategy
The following electronic databases were searched to identify eligible studies updated to January 2018 on conservative therapy vs surgical therapy for acute injury of the lateral ankle ligament: PubMed, The Cochrane Library, and Embase. In addition, literature or publications that were related to this meta‐analysis were identified as well. The literature research process was performed by two reviewers independently. Any differences were settled by discussion with a third reviewer to reach consensus.
2.2. Study selection
The inclusion criteria were as follows: (a) randomised controlled trials or comparative studies; (b) the study patients had no other serious concurrent disease; (c) the surgery group was treated using ligament repair or reconstruction; and (d) the conservative therapy group were treated using plaster fixation, bandage fixation, ankle support, and functional treatment.
The exclusion criteria were as follows: (a) duplicate publications or duplicate contents and results; (b) meta‐analysis, conference report, theoretical research, economic analysis, expert comment, systematic review, and case report; and (c) irrelevant outcomes.
2.3. Data extraction and quality assessment
The search process for all the included studies was performed to determine the above‐mentioned criteria by two reviewers independently. Any differences were settled by discussion with a third reviewer. Data were extracted from all the included studies in two parts: the main outcomes and basic information. The name of the first author, year of publication, study design, country, details of therapy, sample size, and Jadad score were included in the first part. The following clinical outcomes were obtained from the second part: recurrent ankle injury, limited range of motion, ankylosis, deep vein thrombosis (DVT), scar tenderness, sensory loss, necrosis or wound infection, complications, the AOFAS score, and effective rate. The Jadad score checklist was used to appraise the quality of the included studies. We evaluated all the randomised controlled trial (RCTs) in five aspects: appropriateness of generating randomised sequence, randomisation statement, use of double blind, description of double‐blinding methods, and details of withdrawals and dropouts. Studies with a score of less than 3 represented low quality and high bias risks, studies with a score > 3 were indicated to be a high‐quality trial. The above‐mentioned process for all the included studies was performed by two reviewers independently. Any differences were settled by discussion with a third reviewer to reach an agreement.
2.4. Statistics Analysis
Statistical analysis of all the included studies was performed using STATA 10.0 (StataCorp, College Station, Texas). The heterogeneity of clinical trial results was assessed by χ2 and I2 tests to determine the model of analysis (the random‐effects model or the fixed‐effects model). Heterogeneity was considered to be high if the χ2 test P‐value was less than 0.05 and I2 test value was larger than 50%, and the random‐effects model was used. Heterogeneity data were considered to be acceptable if the χ2 test P‐value was larger than 0.05 and I2 test value was less than 50%, and the fixed‐effects model was used. Continuous variables were expressed as mean ± SD and analysed by mean difference (MD). Categorical data were presented as percentages and analysed by relative risk (RR) or odds ratio (OR). Recurrent ankle injury, limited range of motion, ankylosis, DVT, scar tenderness, wound infection or necrosis, sensory loss, complications, and effective rate were analysed by RR and 95% confidence interval (CI). The AOFAS score was analysed by MD and 95% CI.
3. RESULTS
3.1. Study characteristics
A total of 819 articles were identified through search using the indexes. During a brief screening of abstracts and titles, 761 articles were excluded from the current study, leaving 58 articles to be further evaluated. During full‐text screening, 45 articles failed to meet the following criteria: no eligible groups (8), nonblack of clinical outcomes (19), or theoretical research (18). Finally, 13 studies10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 were included in this meta‐analysis, with 834 patients in the surgery group and 930 patients in the conservative therapy group. The overall selection process is shown in Figure 1.
Table 1 summarises the main characteristics of the included studies. The current studies included 16 case‐control groups in 13 studies, RCTs in 10 studies, and retrospective comparative study in 2 studies. The countries of origin included the United Kingdom, Germany, Finland, Denmark, the Netherlands, Australia, Italy, and China in the studies. The main Jadad score was 4.9, which represented high quality of the included RCTs.
Table 1.
Description of the basic characteristics of included studies
Treatment | No. of patients | ||||||
---|---|---|---|---|---|---|---|
Study | Study design | Country | Operation group | Conservative therapy group | Operation group | Conservative therapy group | Jadad score |
Evans et al10 | RCT | England | Suture + plaster | Plaster fixation | 50 | 50 | 5 |
Klein11 | RCT | Germany | Suture + plaster | Plaster fixation | 30 | 30 | 4 |
Korkala et al12 | RCT | Finland | Suture + plaster | Plaster fixation/elastic bandage | 50 | 100 | 2 |
Moller Larsen et al13 | RCT | Denmark | Suture + plaster | Plaster fixation/elastic bandage | 55 | 120 | 3 |
Petersen and Lind14 | RCT | Denmark | Suture + elastic bandage | elastic bandage | 29 | 30 | 6 |
Pijnenburg et al15 | RCT | Netherlands | Suture + plaster | Ankle support | 159 | 158 | 7 |
Povacz et al16 | RCT | Australian | Suture + plaster | Ankle support | 73 | 73 | 7 |
Specchiulli and Cofano17 | RCT | Italy | Suture + plaster | elastic bandage | 50 | 50 | 4 |
Zwipp et al18 | RCT | Germany | Suture + plaster/ankle support | Plaster fixation/ankle support | 102 | 98 | 6 |
Pihlajamaki et al19 | RCT | Finland | Suture + plaster | Ankle support | 25 | 26 | 7 |
Chen20 | Retrospective comparative study | China | Anchor repair/ligament reconstruction | Plaster fixation | 90 | 41 | — |
Zhang and Zhang21 | Retrospective comparative study | China | Surgical treatment | Functional treatment/plaster fixation | 61 | 124 | — |
Zhao and Chen22 | RCT | China | Anchor repair/ligament reconstruction | Plaster fixation | 60 | 30 | 3 |
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Abbreviation: RCT, randomised controlled trial.
3.2. Recurrent ankle injury
Six studies with six case‐control groups provided data on recurrent ankle injury. Based on the I2 test value (I2 = 61.8%) and χ2 test P‐value (P = 0.022), we chose the random‐effects model to analyse recurrent ankle injury. The pooled results showed no significant difference in the incidence of recurrent ankle injury between the two study groups (RR: 1.01, 95% CI: 0.62‐1.65, Figure 2).
3.3. Complications
Twelve studies with 15 case‐control groups provided data on complications. Based on the I2 test value (I2 = 0.0%) and χ2 test P‐value (P = 0.969), we chose the fixed effects model to analyse the complications. The pooled results showed significantly higher rates of complications in the surgery group than the conservative treatment group (RR: 3.31, 95% CI: 2.55‐4.28, Figure 3).
The complications included limited range of motion, ankylosis, DVT, scar tenderness, necrosis or wound infection, and sensory loss. In the subgroup analysis, six studies with nine case‐control groups provided data on limited range of motion. Based on the I2 test value (I2 = 0.0%) and χ2 test P‐value (P = 0.766), we chose the fixed‐effects model to analyse the limited range of motion. The pooled results showed no significant difference in limited range of motion between the two study groups (RR: 1.44, 95% CI: 0.83‐2.50, Figure 4). Four studies with seven case‐control groups provided data on ankylosis. Based on the I2 test value (I2 = 0.0%) and χ2 test P‐value (P = 0.677), we chose the fixed‐effects model to analyse ankylosis. The pooled results showed that the incidence of ankylosis was significantly higher in the surgery group in comparison with the conservative therapy group (RR: 3.63, 95% CI: 2.16‐6.08, Figure 4). Five studies with eight case‐control groups provided data on DVT. Based on the I2 test value (I2 = 0.0%) and χ2 test P‐value (P = 0.953), we chose the fixed‐effects model to analyse DVT. The pooled results showed no significant difference in the incidence of DVT between the two study groups (RR: 1.33, 95% CI: 0.73‐2.41, Figure 4). Six studies with nine case‐control groups provided data on scar tenderness. Based on the I2 test value (I2 = 0.0%) and χ2 test P‐value (P = 0.981), we chose the fixed‐effects model to analyse scar tenderness. The pooled results showed that the incidence of scar tenderness was significantly higher in the surgery group compared with the conservative therapy group (RR: 10.16, 95% CI: 3.89‐26.52, Figure 4). Six studies with nine case‐control groups provided data on sensory loss. Based on the I2 test value (I2 = 0.0%) and the χ2 test P‐value (P = 0.906), we chose the fixed‐effects model to analyse sensory loss. The pooled results showed that the incidence of sensory loss was significantly higher in the surgery group compared with the conservative therapy group (RR: 5.66, 95% CI: 2.76‐11.59, Figure 4). Two studies with two case‐control groups provided data on wound infection or necrosis. Based on the I2 test value (I2 = 0.0%) and χ2 test P‐value (P = 0.817), we chose the fixed‐effects model to analyse the incidence of necrosis or wound infection. The pooled results showed no significant difference in the incidence of wound infection or necrosis between the two study groups (RR: 3.99, 95% CI: 0.45‐35.34, Figure 4).
3.4. AOFAS score
Three studies with six case‐control groups provided data on AOFAS scores. Based on the I2 test value (I2 = 97.8%) and χ2 test P‐value (P = 0.000), we chose the random‐effects model to analyse AOFAS scores. The pooled results showed that, compared with the conservative treatment, surgical treatment significantly increased the AOFAS score (weighted mean difference: 10.33, 95% CI: 6.83‐13.83, Figure 5).
3.5. Effective rate
Three studies with six case‐control groups provided data on the effective rate. Based on the I2 test value (I2 = 65.0%) and χ2 test P‐value (P = 0.014), we chose the random‐effects model to analyse the effective rate. The pooled results showed that the effective rate was significantly higher in the surgery group in comparison with the conservative therapy group (RR: 1.15, 95% CI: 1.04‐1.28, Figure 6).
3.6. Quality assessment and potential bias
In the meta‐analysis, 13 articles were included according to the inclusion and exclusion criteria. The assessment of quality and potential bias were accessed by funnel plot, Egger's test, Begg's, and Mazumdar's rank test. The funnel plot for log RR in complications of the included studies was notably symmetrical, suggesting significant publication bias (Figure 7). Moreover, we detected significant asymmetry using Begg's and Mazumdar's rank test (Z = 1.98, P = 0.048). However, Egger's test result showed significant publication bias (P = 0.032).
4. DISCUSSION
Previous studies have reported some similar meta‐analyses of surgical therapy in comparison with conservative therapy for acute injury of the lateral ankle ligament. Kerkhoffs et al23 found that, when the fixed‐effects model was used, statistical differences were observed in terms of four main outcomes in the surgical treatment group, such as instability of any kind, long‐term pain, recurrence of ankle sprain, and non‐return to pre‐injury sports. The results with extreme outcomes were not robust when the random‐effects model was used or one trial with quasi‐randomised or low quality was removed. It was uncertain if instability in patients receiving conservative treatment is associated with a remarkably higher incidence. In addition, more evidence in the surgical treatment group was needed to confirm mobility with impaired ankle, stiffness of ankle, and longer time of recovery, as well as complications. Hao et al24 reported that, in the surgical treatment group, the stability of ankle activity was better in comparison with that in the functional treatment group, with OR and 95% CI of 0.72 (0.52‐0.99). No significant difference was identified in the recurrence rate in the surgery group and the functional treatment group. However, movement disorder in the surgical treatment group suggested increased risk vs the functional treatment group, with OR and 95% CI of 2.39 (0.98‐5.85). The surgery group was found to have a higher rate of complications than the functional treatment group, such as DVT, scar tenderness, and sensory loss. Wu et al25 reported that the functional stability of the ankle was markedly better in the operative treatment group in comparison with that in the non‐operative treatment group (OR: 0.72, 95% CI: 0.52‐0.99); the incidence of ankle arthroeleisis in the operative therapy group was also observably higher than that in the non‐operative therapy group (OR: 3.41, 95% CI: 1.56‐7.44). There were no statistical differences in mobility recovery (OR: 1.14, 95% CI: 0.58‐2.21), incidence of re‐injury (OR: 0.68, 95% CI: 0.35‐1.31), residual pain (OR: 0.81, 95% CI: 0.56‐1.16), or ankle dyskinesia (OR: 2.38, 95% CI: 0.91‐6.25) between the two study groups. The incidences of scar tenderness (OR: 7.46, 95% CI: 1.32‐42.08) and sensory nerve loss (OR: 12.16, 95% CI: 2.24‐66.02) were dramatically higher in the operative therapy group in comparison with the non‐operative therapy group. The total rate of complications was dramatically higher in the operative treatment group than in the non‐operative treatment group (OR: 6.20, 95% CI: 2.67‐14.41).
It is pivotal to note that our meta‐analysis has several limitations: (a) differences in patients for the above‐mentioned criteria; (b) different patients harbouring other diseases were unavailable for the treatments; (c) the types of treatment in the surgery group and the conservative therapy group were varied; and (d) individual patient data were unavailable, and pooled data were used for analysis, thereby limiting more comprehensive analysis.
Hence, in this meta‐analysis and systematic review, surgical treatment has several advantages, including increased AOFAS scores and a higher effective rate compared with conservative treatment. Therefore, surgical treatment could be a more effective choice. Nevertheless, considering the limitations of this meta‐analysis, more high‐quality RCTs are needed that have a larger sample size and are conducted across multiple centres with long‐term follow ups to confirm the current conclusions.
Liu F‐Q, Diao N‐C. Surgical therapy vs conservative therapy for patients with acute injury of lateral ankle ligament: A meta‐analysis and systematic review. Int Wound J. 2019;16:925–931. 10.1111/iwj.13120
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