1. Dr. Daniel T. DeGenova – OhioHealth Orthopedic Surgery Residency 
2. Dr. Jia Bao Lin – OhioHealth Orthopedic Surgery Residency 
3. Dr. Daniel P. Auger – OhioHealth Orthopedic Surgery Residency 
4. Dr. Craig C. Goubeaux – OhioHealth Orthopedic Surgery Residency 
5. Dr. Paul Myers – OhioHealth Orthopedic Surgery Residency 
6. Mr. Dante A. DeGenova – OhioHealth Orthopedic Trauma and Reconstructive Surgeons
7. Dr. Benjamin C. Taylor – OhioHealth Orthopedic Trauma and Reconstructive Surgeons

Authors
Daniel T. DeGenova^1A, Jia Bao Lin¹, Daniel P. Auger¹, Craig C. Goubeaux¹, Paul Myers¹, Dante A. DeGenova², Benjamin C. Taylor².

1. OhioHealth Health System, Department of Orthopedics, Columbus, OH 43228, United States
2. OhioHealth Orthopedic Trauma and Reconstructive Surgeons, Grant Medical Center, Columbus, OH 43215, United States

A. Corresponding author at: OhioHealth/Doctors Hospital, 5100 West Broad Street, Columbus, OH 43228, United States. E-mail address: [email protected] (D. T. DeGenova).

Abstract

Background
The general consensus after open reduction internal fixation of an ankle fracture with syndesmotic fixation is prolonged non weight-bearing to protect the fixation and allow healing after a significant rotational ankle injury. The aim of this study was to analyze multiple postoperative outcomes of patients who underwent syndesmotic fixation that were allowed to weight bear early compared to those with delayed weight bearing. 

Methods
We retrospectively reviewed two hundred and five patients from our level 1 trauma center with ankle fractures that required syndesmosis fixation. Ninety-seven skeletally mature patients met our selection criteria and were separated into an early weight bearing (eWB) group and a delayed weight bearing (dWB) group. These patients had a minimum of six months follow up and their postoperative outcomes were analyzed. Specific variables of interest were, radiographic outcomes, return to work, evidence of hardware failure, and infection rates. 

Results
A total of 16 patients were in the early weight bearing group and 81 patients in the delayed weight bearing group. There was no difference in radiographic outcome between the groups (p = 0.37). There was an increased rate of hardware failure in the dWB group; however, this was not significant (p = 0.35). No superficial or deep infections were seen in the eWB group. Patients in the eWB group were able to return to work sooner (p = 0.001). 

Conclusion
Based on our findings, there were similar outcomes for the early and delayed weight bearing groups for ankle fractures that had undergone syndesmotic fixation. Our study did not demonstrate any increase in complications with eWB. Our results suggest that allowing patients to walk sooner can be beneficial without compromising the integrity of the hardware.

Level of evidence: Level IV, retrospective review

Keywords: ankle fracture, syndesmosis, early weight-bearing 

Introduction
Rotational ankle fractures are a common injury encountered by orthopedic surgeons and the incidence continues to rise [1]. Unstable ankle injuries often require operative fixation to obtain an anatomic reduction and stable fixation to allow early range of motion and obtain the best possible outcome [2]. There are numerous ways to treat acute ankle fractures in the literature including closed reduction and percutaneous pinning, external fixator placement, open reduction and internal fixation (ORIF) with plate and screw construct, tibiotalocalcaneal nailing and other options described in the literature [2-6]. Furthermore, if the syndesmosis is disrupted, stabilization is indicated using various methods of treatment [7]. The need for open reduction internal fixation (ORIF) of unstable ankle fractures, with stabilization of the syndesmosis when disrupted, has been well established in literature and is the standard of care among orthopedic surgeons [8].

It is commonly found in the literature that the most common postoperative protocol following ORIF for an ankle fracture involving the syndesmosis is to keep patients non-weight bearing for six to twelve weeks postoperatively [9,10]. There has been a recent trend in literature towards early weight bearing after operative ankle fixation [11-13]; however, much of this data does not include or does not specifically address the involvement of the syndesmosis. In a systematic review by Black et al., there were statistically significant better outcomes in the early weight-bearing cohort with improved dorsiflexion, time to full weight bearing, and earlier return to work [14].

There are many ways to stabilize the syndesmosis [7]. A recent systematic review has suggested that suture button devices may lead to superior outcomes versus screw fixation; however, both are currently acceptable methods of syndesmosis fixation [15]. In the current study, we plan to review all syndesmosis fixation cases from our level I trauma center over the past 10 years, group them based on time to weight bearing, and analyze the groups for complications including hardware failure, reoperation, and infection. Our hypothesis is that there will be no statistically significant difference in our outcomes of interest between early weight-bearing and late weight-bearing cohorts. With no difference in outcomes, this will help establish early weight bearing after syndesmosis fixation as a safe rehabilitation protocol.

Methods and Materials
Formal institutional review board approval was obtained prior to initiation of this study. We conducted a retrospective chart review at an urban level 1 trauma center from January 1, 2010 to August 1, 2021 on patients who sustained an ankle fracture of various morphology and underwent ORIF with syndesmosis fixation. In our database, a total of 205 patients were identified and were treated by five different fellowship-trained orthopedic traumatologists with varying weight-bearing protocols.

Inclusion criteria included:

1. age 18 years or older,
2. underwent open reduction and internal fixation of an ankle fracture, and
3. had a minimum of six months follow up.

Exclusion criteria included:

1. patient who were polytraumatized which weight bearing could be compromised,
2. definitive surgical fixation greater than 14 days after injury,
3. previous surgery on the ipsilateral ankle,
4. grade III open injuries,
5. any injuries that were not able to be closed at the primary procedure. 

Of the 205 patients, a total of 97 patients met the inclusion/exclusion criteria and were included in our analysis. Demographic variables and fracture characteristics were collected. Patients were divided into an early weight-bearing group, consisting of any patients who started mobilizing at or before three weeks from surgery, and the delayed weight-bearing group, who started mobilizing after three weeks. For syndesmosis fixation, patients either received suture button fixation, screws, or both. Screws that were utilized for syndesmotic fixation included 2.7mm, 3.5mm and 4.0mm. Suture button fixation that was implanted were either the Arthrex Syndesmosis TightRope XP Implant System (Naples, FL), Zimmer-Biomet ZipTight Ankle Syndesmosis System (Warsaw, IN), or DePuy Synthes FIBULINK Syndesmosis Repair System (Warsaw, IN). It was also noted if the final construct included posterior malleolus fixation, as this can augment the biomechanical properties of the syndesmosis. 

Our primary outcomes measured consisted of radiographic evidence of nonunion, malunion, joint incongruence, and other poor radiographic outcomes. Other variables assessed were evidence of hardware failure, infection, length of hospital stay, and time to return to work. Statistical analysis was performed with means, ranges, and confidence intervals calculated for continuous variables and compared using Student’s t-tests. Categorical variables were analyzed with chi-square and Fisher’s exact test. A p-value of <0.05 was considered statistically significant. Microsoft Excel (Redmond, WA) was used for data computation. 

Results
A total of 205 patients were reviewed for undergoing ORIF of unstable ankle and syndesmotic ankle injuries with 97 patients meeting inclusion criteria. These were separated into an early weight-bearing group (eWB) (Figure 1 and 2), which consisted of 16 patients, and a delayed weight-bearing group (dWB) with 81 patients. Demographic data can be found in Table 1. No differences were seen between the types of ankle fracture pattern (Table 2). In the eWB group, time to the operating room from injury was an average of 4.6 days, and 2.3 days for the dWB group. Table 3 demonstrates the syndesmotic fixation. Of the 16 in the eWB group, three patients received screws for syndesmotic fixation, 12 with a suture device, and one with both. In the dWB group, 49 of the 81 patients received screws for syndesmotic fixation, 24 with a suture device, three with both, and five with other forms of syndesmotic fixation. In addition to the syndesmotic fixation, 18.7% of the eWB group and 11.1% of the dWB group received posterior malleolus fixation. Postoperative variables are shown in Table 4. The follow-up period was an average of 29 and 21 weeks for eWB and dWB, respectively (p = 0.11). There was no difference between radiographic nonunion, malunion, or joint incongruence between the groups (p = 0.37). There was less evidence of hardware failure in the eWB group; however, this was not significant. No superficial or deep infections were seen in the eWB group. Patients in the eWB group were able to return to work earlier and this was significant (p = 0.001). 

Discussion
In the orthopedic community, there is much controversy between eWB versus dWB when it comes to postoperative protocol after ORIF of an ankle fracture. Although the weight bearing protocols vary based on training and comfortability, there is evidence to suggest that eWB after ankle ORIF is safe with increased range of motion, and earlier return to work without an increase in complications [11-13,16,18]. Recent studies have demonstrated that patients with unstable ankle fractures requiring syndesmotic fixation can safely undergo eWB; they are not at an increased risk of hardware failure or radiographic malunion or nonunion [8,12,17,18]. An extended time of inactivity and immobilization can delay recovery and even become detrimental to a patient’s prognosis. In a randomized control trial conducted by Park et al., they demonstrated that patients who underwent earlier weight-bearing returned to preinjury activities sooner than the delayed weight-bearing group [19]. 

In our literature review there was a paucity of information discussing the results of early weight-bearing, especially before three weeks in patients undergoing operative fixation of their syndesmotic injury. This study showcases that early weight-bearing in patients with ankle fractures requiring syndesmotic fixation is safe with no difference in complications and allows earlier return to work. The patients returned to work at an average of 6 weeks versus 16.8 weeks with eWB versus dWB, respectively. This drastic difference in return to work is worth noting as it tremendously decreases the total amount of lost wages and mitigates financial burdens. In a systematic review and meta-analysis conducted by Smeeing et al., they analyzed patients who underwent ORIF of ankle fractures. This study demonstrated that eWB is associated with an earlier return to work and daily activities compared to dWB [20].  

There were also differences in certain outcomes between the eWB and dWB groups that were notable but not statistically significant: the absence of poor radiographic outcomes was 87.5% for the eWB group and 77.78% for the dWB group. Lower rates of hardware failure were noted in the eWB group (6.25%) compared to the dWB group (14.8%). Similar to this, AI-Hourani et al. conducted a retrospective cohort study including patients who sustained an unstable ankle fracture requiring syndesmotic fixation. Patients underwent protected weight-bearing or full weight-bearing in the early post-operative period. They found that early full weight-bearing did not lead to syndesmotic diastasis on radiographs at six weeks and 12 weeks post-operatively [17]. This data supports that eWB does not promote syndesmotic fixation failure. 

Similar to this study, Pyle et al. conducted a retrospective review of patients with unstable ankle fractures that underwent operative fixation. The patients began weight-bearing between two to four weeks and showed no evidence of hardware failure. There were only three cases of superficial wound infection. All went on to heal after being treated with protected weight-bearing and one patient also received oral antibiotics [8]. Concern for hardware failure and subsequent loss of reduction is a primary reason why many orthopedic surgeons do not allow eWB. Our study’s findings do not support these concerns and indicate that eWB is safe. 

There are a few limitations to this study. One of the most apparent limitations is the patient attrition and lack of follow-up that occurred. This was particularly evident in our eWB group. The eWB group in our study only included 16 patients compared to the 81 in the dWB group. The relatively small number of patients in the eWB group limits the power of the study. One of our inclusion criteria was a minimum of six months follow-up. A potential reason for the low number of eWB patients meeting this criterion was their good clinical status and perceived lack of need for follow-up. Another limitation of our study was the lack of a formal functional status score. This could have provided insight into the patient’s interpretation of their status and well-being. These limitations could be addressed by future higher-powered studies that include functional status scores. 

Conclusion
Based on our findings, there were similar outcomes for the early and delayed weight bearing groups for ankle fractures that have had syndesmotic fixation. Our study did not demonstrate any increase in complications with early weight bearing. In fact, patients that were allowed to walk sooner had a shorter hospital stay and an earlier return to work. These results suggest that allowing patients to walk sooner can be beneficial without compromising the integrity of the hardware. However, high quality randomized control trials with a larger sample, especially patients in the early weight bearing group, is needed to better elucidate if a difference in complication rates exist or not.  

Figure 1 | Figure 2 | Figure 3 | Figure 4 | Photo 1 | Photo 2

Figure Legends
Photo 1. Pre-operative, injury radiographs of the left ankle in a patient in the eWB group.

Photo 2. Post-operative radiographs of the same patient as imaged in Figure 1, status post open reduction and internal fixation with syndesmotic fixation.

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