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Volume:4 Issue:12 Number:4 ISSN#:2563-559X
OE Original

Suture Button Versus Screw Fixation for Syndesmosis Injuries: A systematic Review and Meta-analysis

Authored By: OrthoEvidence

December 29, 2021

How to Cite

OrthoEvidence. Suture Button Versus Screw Fixation for Syndesmosis Injuries: A systematic Review and Meta-analysis. OE Original. 2021;4(12):4. Available from: https://myorthoevidence.com/Blog/Show/162

Highlights


- In this OE Original, we systematically examined and quantitatively synthesized evidence from randomized controlled trials (RCTs) comparing the efficacy and safety outcomes between suture button fixation and syndesmotic screw fixation in patients with syndesmosis injuries.


- Seven RCTs were identified from nine included articles. Two RCTs received no funding, two were supported by hospitals and/or orthopedic associations, two were funded by the suture button manufacturer, and one RCT did not specify its funding source.


  • - Moderate quality of evidence suggested that suture button fixation was superior to screw fixation for the short term as suture button significantly reduced pain [MD (mean difference): -5.22, 95% confidence interval (CI): -9.60 to -0.84] and improved the score of the American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale (MD: 3.31, 95% CI: 0.10 to 6.52) at <= 3 months post fixation.


  • - Suture button fixation was found to be safer than screw fixation as the risk of reoperation was significantly lower [relative risk (RR): 0.48, 95% CI: 0.24 to 0.96, moderate quality of evidence].


  • - No clear conclusion could be drawn from low to very low evidence regarding the long term efficacy of suture button fixation over screw fixation. More RCTs with high methodological quality, large sample size, and longer follow-up time periods are warranted.


  • - Cost-effectiveness analyses will be necessary and helpful for the decision-making about the implant selection for syndesmotic fixation by finding a balance between obtaining the best clinical outcomes and remaining fiscally responsible.






Syndesmosis injuries can occur in isolation or associated with ankle fractures, and if not properly treated, the injuries may result in ankle dysfunction (Wake et al., 2020).


Syndesmotic screw fixation and suture button fixation are both operative techniques to stabilize the unstable syndesmosis as a result of injuries (Wake et al., 2020). The former is a static fixation with one or multiple screws of different sizes engaging three or four cortices (Bava et al., 2010), while the latter is in nature a dynamic fixation which allows for a certain degree of positional variance while maintaining an accurate syndesmosis reduction (Westermann et al., 2014).


Suture button fixation has gained increasing popularity over the use of syndesmotic screws. A number of systematic reviews and meta-analyses have been conducted to compare these two treatments (e.g., Chen et al., 2019; Grassi et al., 2020; Kennedy et al., 2019; Marasco et al., 2021; McKenzie et al., 2019; Onggo et al., 2020; Shimozono et al., 2019; Tian et al., 2020).


In the present OE Original, we conduct an up-to-date systematic review and meta-analysis to examine evidence from randomized controlled trials (RCTs) comparing the efficacy and safety outcomes between suture button fixation and syndesmotic screw fixation in patients with syndesmosis injuries.




Methods


Ovid MEDLINE, Ovid EMBASE, Cochrane Controlled Register of Trials (CENTRAL), and OrthoEvidence were searched from inception to December 7, 2021 with both indexed terms and free text terms with regard to suture button and screw fixation for syndesmosis injuries. Reference lists and existing systematic reviews (i.e., Chen et al., 2019; Grassi et al., 2020; Kennedy et al., 2019; Marasco et al., 2021; McKenzie et al., 2019; Onggo et al., 2020; Shimozono et al., 2019; Tian et al., 2020) were also searched to identify additional eligible studies.


Eligible studies should be RCTs which compare suture button with screw fixation for syndesmosis injuries either associated with ankle fracture or not. Eligible studies should be published in English and have access to full texts. Studies conducted in cadavers or conference abstracts were excluded.


We adopted the Cochrane risk-of-bias tool and the GRADE approach to determine the risk of bias of the included RCTs and the quality of evidence, respectively. Two reviewers independently worked on the systematic review processes, such as study screening, selection, data extraction, and risk of bias assessment. Any disagreement was resolved by consulting a third reviewer.




Results


1. Characteristics of included studies


In total, 482 records were retrieved and screened. Nine articles were eligible and included (Andersen et al., 2018; Coetzee et al., 2009; Colcuc et al., 2018; Kortekangas et al., 2015; Laflamme et al., 2015; Lehtola et al., 2021; Raeder et al., 2020a; Raeder et al., 2020b; Sanders et al., 2019).


The characteristics of the included studies were presented in Table 1. The nine included articles reported seven RCT patient cohorts. Andersen et al. (2018) and Raeder et al. (2020b) followed up with the same patient cohort, and so Kortekangas et al. (2015) and Lehtola et al. (2021) did.


Most of the RCTs were conducted in Europe with three RCTs being done in Canada (2) and the United States (1). All of the included studies stated the funding source except Coetzee et al. (2009). Two RCTs received no funding, two were supported by hospitals and/or orthopedic associations, and two were funded by Arthrex Inc, the manufacturer of the TightRope suture button.


The number of participants at randomization ranged from 24 to 113. All participants suffered a syndesmosis injury with or without ankle fracture. All of the RCTs carried out suture button fixation using TightRope manufactured by Arthrex Inc but one , which used Ziptight suture button developed by Zimmer Biomet (Raeder et al., 2020a).


Variance in screw fixation, in terms of the number of screws used (1 or 2 screws), the diameter of the screws (3.5 mm, 4.5 mm, or a mix of 4.0, 4.5 and 6.5 mm depending on the size of the fibula and ankle), and how many cortices were engaged (3 or 4 cortices), was found across the control groups among the included RCTs. here were five types of screw fixation among the seven RCTs: one 4.5-mm quadricortical syndesmotic screw (1 RCT), one 3.5-mm tricortical syndesmotic screw (3 RCTs), one 3.5-mm quadricortical screw (1 RCT), two 3.5-mm cortical positional screws placed across 3 cortices (1 RCT), as well as two quadricortical screws which diameter was dependent upon the size of the fibula and ankle including 4.0, 4.5, and 6.5 mm screws (1 RCT).


Table 1. Characteristics of included studies

Study ID

Country

Funding Source

No. of Patients*

Condition

Age (years)**

Intervention (Suture Button)

Control (Screw)

Andersen 2018

Norway

Vestre Viken Hospital Trust and the Norwegian Orthopedic Association

97

Acute traumatic injury to the syndesmosis, with or without a concomitant OTA/AO type 44-C ankle fracture

Suture Button: 46 (14.8); Screw: 43 (16.2)

Suture button using TightRope (Arthrex)

One 4.5-mm quadricortical syndesmotic screw (Synthes)

Coetzee 2009

United States

Not Reported

24

Syndesmosis injuries (less than 1 month old) with or without ankle fractures

Suture Button: median: 38, range: 18-55; Screw: 35, 18-53

Tightrope fiber wire (Arthrex)

Two screws and all included 4 cortices (diameter was dependent upon the size of the fibula and ankle including 4.0, 4.5 and 6.5 mm screws)

Colcuc 2018

Germany

No funding

62

Acute syndesmosis disruption with or without ankle fracture

Suture Button: median: 35, range: 18-60; Screw: 39, 18-60

TightRope

One 3.5-mm transosseous syndesmotic screw purchasing 3 cortices

Kortekangas 2015

Finland

Oulu University Central Hospital

43

Syndesmotic disruption with Lauge-Hansen pronation-external rotation-, AO/OTA Weber C-type ankle fracture

Suture Button: 46 (14.8); Screw: 43.5 (15.7)

TightRope

One 3.5-mm tricortical trans-syndesmotic screw

Laflamme 2015

Canada

The corresponding author received an unrestricted grant from Arthrex Inc.

70

Acute ankle fracture with syndesmotic rupture

Suture Button: 40.1 (14.8); Screw: 39.3 (12.4)

TightRope

One 3.5-mm quadricortical screw

Lehtola 2021

Finland

No funding

43

Syndesmotic disruption with Lauge-Hansen pronation-external rotation-, AO/OTA Weber C-type ankle fracture

Suture Button: 46 (14.8); Screw: 43.5 (15.7)

TightRope

One 3.5-mm tricortical trans-syndesmotic screw

Raeder 2020a

Norway

No external funding

113

Acute AO type 44-C ankle fracture with syndesmosis injury

Suture Button: 44 (15); Screw: 48 (14)

Ziptight suture button (Zimmer Biomet)

One tricortical 3.5-mm syndesmotic screw

Raeder 2020b

Norway

Vestre Viken Hospital Trust and the Norwegian Orthopedic Association

97

Acute traumatic injury to the syndesmosis, with or without a concomitant OTA/AO type 44-C ankle fracture

Suture Button: 46 (14.8); Screw: 43 (16.2)

TightRope (Arthrex)

One 4.5-mm quadricortical syndesmotic screw (Synthes)

Sanders 2019

Canada

Arthrex Inc.

108

Fibular fractures proximal to the syndesmosis with an associated syndesmosis injury (OTA/AO 44-C injuries)

Suture Button: 41 (12); Screw: 38 (14)

TightRope (Arthrex)

Two 3.5-mm cortical positional screws placed across 3 cortices

* Number of patients at randomization; ** Age was represented as mean and standard deviation unless otherwise specified.




The risk of bias assessment is shown in Figure 1. The major concern was that most of the RCTs found it challenging to blind participants or outcome assessors. The included studies performed relatively well in other items such as random sequence generation, allocation concealment, incomplete outcome data, and selective reporting. We also examined the role of the experience of surgeons presented as other bias (Figure 1). All of the RCTs except Coetzee et al. (2009) described the experience of the surgeons involved.









2. Quantitative synthesis


2.1 Pain on a normalized scale


We quantitatively synthesized the pain outcomes on a normalized scale with a range between 0 and 100. A higher score indicates worse pain.


Fixation with a suture button significantly relieved pain at <= 3 months after surgery in patients with syndesmosis injury, compared to screw fixation [mean difference (MD): -5.22, 95% confidence interval (CI): -9.60 to -0.84] (Figure 2). However, no significant differences were observed in pain between suture button and screw fixation at 6 months, 1 year, or 2 years (Figure 2).


Raeder et al. (2020b) and Lehtola et al. (2021) also reported pain on a visual analogue scale (VAS pain) at 5 years and RAND-36 Item Health Survey for Quality-of-Life (RAND-36) bodily pain at about 7 years, respectively. Neither of them found statistically significant differences between suture button and screw fixation.




2.2 American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale


The AOFAS ankle-hindfoot scale ranges from 0 to 100, with a higher score indicating better outcome.


The scores of the AOFAS ankle-hindfoot scale were significantly improved in patients with suture button fixation at <= 3 months (MD: 3.31, 95% CI: 0.10 to 6.52) and 5 years (MD: 5.66, 95% CI: 1.36 to 9.96), compared to those in patients with screw fixation (Figure 3). No significant differences were identified for the AOFAS ankle-hindfoot scale at 6 months, 1 year, or 2 years (Figure 3).


2.3 Olerud-Molander Ankle (OMA) scale


Olerud-Molander Ankle (OMA) scale ranges from 0 to 100. A higher score indicates a better outcome.


There were no significant differences in the scores of the OMA scale between suture button and screw fixation at <= 3 months, 6 months, 1 year, 2 years, or >= 5 years after operation (Figure 4).



2.4 EuroQol-5D (EQ-5D) index


Values of the EQ-5D index are anchored at 0 (a state as bad as being dead) and at 1 (full health).


No significant differences in the EQ-5D index were identified between suture button and screw fixation at 6 weeks, 6 months, 1 year, 2 years, or >= 5 years after operation (Figure 5).






2.5 Loss of reduction and Reoperation


There were no significant differences in the incidence of loss of reduction between suture button and screw fixation (Figure 6).


The risk of reoperation was significantly lower in patients receiving suture button fixation than those receiving screw fixation [relative risk (RR): 0.48, 95% CI: 0.24 to 0.96] (Figure 6).





Summary and Discussion


In this OE Original, we conducted a systematic review and meta-analysis comparing the efficacy and safety of suture button fixation with screw fixation in patients who had a syndesmotic injury with or without ankle fracture.


In total, nine studies consisting of seven RCT cohorts were included. There seemed to be a relatively low risk of sponsorship bias since only two RCTs were funded by the manufacturer of the suture button. Another major concern regarding risk of bias was that almost all of the RCTs were not able to blind participants or outcome assessors due to the nature of the fixation.


A number of efficacy and safety outcomes were quantitatively synthesized, which was summarized in Table 2. Moderate quality of evidence suggested that suture button fixation was superior to screw fixation in terms of significantly reducing short-term pain (<= 3 months, MD: -5.22, 95% CI: -9.60 to -0.84) and improving the score of the AOFAS ankle-hindfoot scale in the short term (<= 3 months, MD: 3.31, 95% CI: 0.10 to 6.52) (Table 2). Suture button also markedly improved the score of the AOFAS ankle-hindfoot scale at 5 years (MD: 5.66, 95% CI: 1.36 to 9.96), however, the quality of evidence was very low (Table 2).


Suture button fixation seems to be safer than screw fixation as it showed a significantly lower risk of reoperation (RR: 0.48, 95% CI: 0.24 to 0.96, Moderate quality of evidence). No significant differences were found between the two fixation types in the incidence of loss of reduction (Table 2).


The remaining outcomes meta-analyzed favored suture button fixation but without statistical significance (Table 2). No conclusions could be drawn based on these outcomes which were rated as low to very low quality of evidence. Major concerns regarding the assessment focused on serious risk of bias due to not blinding participants and outcome assessors, inconsistency as a result of heterogeneity, and imprecision due to small sample size. More RCTs with high methodological quality, large sample size, and long follow-up time period are warranted especially for the long-term efficacy outcomes of suture button fixation as opposed to screw fixation.


Finally, when making the decision for the implant selection for syndesmotic fixation, finding a balance between obtaining the best clinical outcomes and remaining fiscally responsible is critical. This requires us to assess the cost associated with suture button and screw fixation and warrants a cost-effectiveness analysis.








Table 2: Summary of meta-analysis and quality of evidence

Outcomes

Point Estimate Favors

Statistical Significance

Quality of Evidence

Pain (<= 3 months)

Suture Button

Yes

MD: -5.22,

95% CI: -9.60 to -0.84

Moderate

Pain (6 months)

Suture Button

No

Low

Pain (1 year)

Suture Button

No

Low

Pain (2 years)

Suture Button

No

Low

AOFAS ankle-hindfoot scale (<= 3 months)

Suture Button

Yes

MD: 3.31,

95% CI: 0.10 to 6.52

Moderate

AOFAS ankle-hindfoot scale (6 months)

Suture Button

No

Low

AOFAS ankle-hindfoot scale (1 year)

Suture Button

No

Low

AOFAS ankle-hindfoot scale (2 years)

Screw

No

Very Low

AOFAS ankle-hindfoot scale (5 years)

Suture Button

Yes

MD: 5.66,

95% CI: 1.36 to 9.96

Very Low

OMA scale (<= 3 months)

Suture Button

No

Low

OMA scale (6 months)

Suture Button

No

Low

OMA scale (1 year)

Suture Button

No

Low

OMA scale (2 years)

Suture Button

No

Very Low

OMA scale (5 years)

Screw

No

Very Low

EQ-5D (6 weeks)

Suture Button

No

Low

EQ-5D (6 months)

Suture Button

No

Low

EQ-5D (1 year)

Suture Button

No

Low

EQ-5D (2 years)

Suture Button

No

Very Low

EQ-5D (5 years)

Neither

No

Very Low

Loss of reduction

Suture Button

No

Low

Reoperation

Suture Button

Yes

RR: 0.48,

95% CI: 0.24 to 0.96

Moderate

MD: mean difference; 95% CI: 95% confidence interval; AOFAS: American Orthopaedic Foot & Ankle Society; OMA scale: Olerud-Molander Ankle scale; EQ-5D: EuroQol-5D; RR: relative risk or risk ratio.





Bottom Line


Moderate quality of evidence suggests that I) suture button fixation is superior for the short term to screw fixation as it significantly reduced pain and improved the score of the AOFAS ankle-hindfoot scale at <= 3 months after fixation; II) Suture button fixation is safer than screw fixation as it showed a significantly lower risk of reoperation. However, no clear conclusion could be drawn from low to very low evidence regarding the long-term efficacy of suture button fixation over screw fixation. More RCTs with high methodological quality, large sample size, and long follow-up time period are warranted. Cost-effectiveness analyses are also needed and will be helpful for the decision-making about the implant selection for syndesmotic fixation.











References


Andersen, M. R., et al. (2018). Randomized trial comparing suture button with single syndesmotic screw for syndesmosis injury. Journal of Bone and Joint Surgery - American Volume, 100(1), 2-12. doi:http://dx.doi.org/10.2106/JBJS.16.01011

Bava, E., et al. (2010). Ankle fracture syndesmosis fixation and management: the current practice of orthopedic surgeons. Am J Orthop (Belle Mead NJ), 39(5), 242-246.

Chen, B., et al. (2019). To compare the efficacy between fixation with tightrope and screw in the treatment of syndesmotic injuries: A meta-analysis. Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons, 25(1), 63-70. doi:https://dx.doi.org/10.1016/j.fas.2017.08.001

Coetzee, J. C., et al. (2009). Treatment of syndesmoses disruptions: A prospective, randomized study comparing conventional screw fixation vs TightRope® fiber wire fixation - medium term results. SA Orthopaedic Journal, 8, 32-37.

Colcuc, C., et al. (2018). Lower complication rate and faster return to sports in patients with acute syndesmotic rupture treated with a new knotless suture button device. Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 26(10), 3156-3164. doi:http://dx.doi.org/10.1007/s00167-017-4820-3

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