Minimum 5-Year Follow-up Results: CROSSBAT (Combined Randomised and Observational Study of Surgery vs No Surgery for Type B Ankle Fracture Treatment)

Abstract

Background:

Isolated Weber B, AO (Association for the Study of Internal Fixation) type 44B ankle fractures with no fracture to the medial side are the most common type of ankle fracture and may be treated with internal fixation or without surgery.

This study aimed to determine if surgery is superior to nonsurgical management for the treatment of these fractures after a minimum 5-year follow-up.

Methods:

Design: A pragmatic, multicenter, single-masked, randomized controlled trial with minimum 5-year follow-up. Setting/participants/interventions: Participants between 18 and 65 years with AO type 44B ankle fracture and minimal talar shift were recruited from 22 hospitals in Australia and New Zealand. Participants willing to be randomized were randomly allocated to undergo surgical fixation followed by mobilization in a walking boot for 6 weeks. Those treated nonsurgically were managed in a walking boot for 6 weeks. Outcome assessors were masked for the treatment allocation. Primary outcomes: Patient-reported ankle function using the American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire (FAOQ) and the physical component summary (PCS) of the SF-12v2 General Health Survey at 12 months postinjury and at minimum 5 years post injury. Primary analysis was intention-to-treat.

Results:

Of the 160 (80 surgical, 80 nonoperative) randomized patients included in the CROSSBAT analysis, 77 (40 surgical, 37 nonoperative) were followed up for repeat analysis at minimum 5-year follow-up (mean 7.3 years, range 5.1-8.9). This cohort demonstrated that surgery was not associated with clinically or statistically significant differences compared to nonoperative management for the FAOQ (51.7 vs 49.6; mean difference 2.1, 95% CI –2.1 to 6.2, P = .95), or the PCS (51.5 vs 49.1; mean difference 2.3, 95% CI –2.0 to 6.7, P = .54). The surgical cohort had a higher rate of any adverse events (odds ratio 3.7, 95% CI 1.2-11.6, P = .04).

Conclusion:

The results of this study suggest that surgical management is not superior to nonsurgical management in type B ankle (fibula) fractures with minimal talar shift over a 5-year period and is associated with increased adverse events.

Level of Evidence:

Level II, randomized clinical trial.

Keywords

ankle fracture randomized controlled trial internal fixation surgery vs nonsurgery Weber B fibula fracture

Background

Ankle fractures are common, with 1 in 800 people fracturing their ankle every year.^2,5,7,14 The most common pattern involves a fracture of the distal fibula (lateral malleolus) at the level of the tibiofibular syndesmosis, otherwise known as a Weber B, AO (Association for the Study of Internal Fixation) or OTA (Orthopaedic Trauma Association) type 44B ankle fracture.^4,6,13,20 If combined with significant displacement of the ankle mortise or a fracture of the medial malleolus, surgical fixation is the preferred treatment. However, the most common Weber B, AO type 44B ankle fracture is one that involves the lateral malleolus, without displacement of the talus or fracture of the medial malleolus (AO/OTS type 44-B1).¹⁵

Management options for 44-B1 ankle fractures include surgical stabilization by internal fixation using a plate and screws or nonsurgical management using a cast or a walking boot.⁷ Advocates for surgical management emphasize the importance of internal fixation in limiting the potential for the development of displacement and instability.^8,15,29 Advocates for nonsurgical management argue that functional outcomes are not superior with surgical stabilization and surgery is associated with increased costs and possible adverse events.^18,24,25 These include the general risks of anesthesia and surgery such as venous thromboembolism, infection, failure of fixation, or the need for revision surgery.

A national survey of 358 orthopaedic surgeons in Australia revealed that surgical management of this common fracture is preferred by approximately 40% of surgeons, despite a lack of evidence to support this approach.¹ Recognizing the costs and risks associated with surgery, the lack of evidence supporting the benefit of surgery and the considerable practice variation, we conducted a randomized trial to determine the comparative effectiveness of surgical and nonsurgical management of this particular common pattern of fracture.

The study (CROSSBAT: Combined Randomised and Observational Study of Surgery for Type B Ankle Fracture Treatment) demonstrated that surgical management is not superior to nonsurgical management for the treatment of 44-B1 ankle (fibula) fractures with minimal talar shift at 1 year and is also associated with increased adverse events.¹⁷ The current study reports results of participants enrolled in CROSSBAT with a minimum 5-year follow-up. The primary aim was to determine whether surgical management confers better longer-term patient-reported ankle function and quality of life for participants with isolated AO type 44-B1 distal fibula fractures when compared with nonsurgical management. Secondary outcomes included between-group differences in mental health quality of life and adverse events.

Methods

Study Design

CROSSBAT was an international, multicenter, randomized controlled trial with an observational cohort. The protocol and results have been published.¹⁷ This study recruited individuals with isolated, closed AO-type 44-B1 distal fibular fractures without significant talar shift presenting within 10 days of injury. Significant talar shift was defined as medial clear space being at least 2 mm wider than the superior clear space on a mortise radiograph view of the ankle. Further inclusion criteria were patients aged between 18 and 65 years inclusive with no other concomitant fractures/dislocations, mobilizing unaided/independently preinjury, and willing to be followed up for 12 months. Exclusion criteria were participants who were medically unfit for anesthesia/surgery; skeletally immature; previous trauma or surgery to the fractured ankle; inability to consent; pregnancy; the presence of comorbidities that impede mobilization; and non-English speaking.

In terms of postoperative care, surgical patients were treated in a cast or boot and nonweightbearing for 6 weeks postoperatively. Nonsurgical patients were allowed full weightbearing in a boot. DVT prophylaxis was at the discretion of treating surgeons and not dictated by the study protocol.

The current study was a follow-up of the CROSSBAT participants at a minimum 5 years postinjury assessing patient-reported ankle function and quality of life outcomes. At the 1-year follow-up, patients enrolled in CROSSBAT were advised they may be contacted at 5 years postinjury to assess their ankle function and quality of life. Participants who were willing to be contacted for the 5-year follow-up were contacted by telephone and verbal consent was sought again. The study was approved by the Hunter New England Human Research and Ethics Committee (approval number: 16/05/18/5.12). The study was registered on www.clinicaltrials.gov (NCT03083028).

Outcomes

The primary endpoints assess the functional outcomes and quality of life at a minimum 5 years post injury. Outcome assessors were masked to treatment allocation.

Ankle function measured using the American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire (FAOQ): The FAOQ uses the Global Foot and Ankle Scale that assesses overall function and pain. The FAOQ is a validated, participant-reported outcome that assesses ankle function, with a higher score indicating better function.^9,26 Normative FAOQ scores were used, with a score of 50 representing the mean in the general population and an SD of 10. A 5-point difference (0.5 SD) was regarded as the minimum clinically important difference.

The physical component summary (PCS) of the General Health Survey measured at 5 years post injury using the Medical Outcomes Study Short Form (SF-12v2): The SF-12v2 is a validated participant-reported outcome, with a higher score indicating better function that has been used for the assessment of people with ankle fractures.^21,27,30,31

The mental component summary (MCS) of the General Health Survey measured at 5 years post injury using the (SF-12v2).

The original CROSSBAT study had already demonstrated that surgical management was associated with increased adverse events. For completeness, at 5 years, participants were again asked if they had suffered any complications. The complication rate, therefore, reflects the entire study period and includes adverse events within the first 12 months. It was apparent during the initial CROSSBAT study that patients were noncompliant with the request for radiographs and therefore no attempt was made in this 5-year study to obtain further radiographs.

Sample Size

The sample size was dictated by CROSSBAT. It had 160 participants in the randomized cohort. This provided 80% power to detect a 0.5-SD difference in the primary outcomes between the 2 groups at a significance level of .05, allowing for 20% loss to follow-up. At 1 year, a sample of 139 patients (87%) of the randomized cohort had been attained from the original study. The current study had a sample size of 77 randomized patients (48%).

Statistical Analysis Plan

Only the randomized cohort was assessed for 5-year outcomes because of high loss to follow-up at 1 year for those in the observational arm. The primary analysis was conducted using intention-to-treat principles. The results were not normally distributed. Student t test was used to compare continuous variables between groups. Chi-squared or Fisher exact test was used for categorical data analysis as appropriate. Statistical analysis was conducted using SAS 9.4 (Cary, NC, USA). Both primary outcomes were required to be significantly better in the surgical arm in order for the latter to be regarded as superior.

Results

From August 15, 2010, to October 3, 2013, 436 participants who presented with an isolated, closed AO type 44-B1 distal fibula fracture with minimal talar shift were screened and all were recruited; 160 participants were randomized, and all 276 participants who declined randomization were included in the observational cohort. The cohort ascertainment and retention are presented in Figure 1. Note patients lost to follow-up at both the 12-month and 5-year intervals.

Thirty-seven (46%) and 40 (50%) participants were available for follow-up in the nonsurgical and surgical groups, respectively, for the minimum 5-year follow-up. This represents 48% of the original randomized cohort, or 55% of the cohort followed up at 12 months. Mean follow-up was 7.3 years, with a range 5.1-8.9 years (Q1 6.7, Q3 8.2, IQR 1.5 years).

Baseline demographics and 12-month follow-up results were similar between those who were followed up vs those who were lost to follow-up as shown in Tables 1 and 2.

Table 1.

Demographic Information Comparing Individuals From the Randomized Cohort Who Were Lost to Follow-up vs Those Who Were Included in the Current Study.

Variable	Followed Up (n=77)	Loss to Follow-up (n=83)	P Value
Age, y, mean (SD)	39.8 (13.4)	38.2 (13.2)	.43
Female, n (%)	36 (47)	47 (57)	.21
BMI, mean (SD)	28.3 (6)	27.9 (6)	.62
Mechanism, n (%)			.71
Fall <1 m	65 (84)	72 (87)
Fall >1 m	8 (10)	6 (7)
Motor vehicle accident	4 (5)	3 (4)
Education, n (%)			.15
High school or lower	31 (40)	44 (53)
TAFE/diploma	31 (40)	22 (27)
University or above	15 (20)	14 (17)
Diabetes mellitus, n (%)	4 (5)	3 (4)	.65
Smoker, n (%)^a	23 (30)	34 (41)	.11
Working, n (%)	67 (87)	67 (81)	.45
Insurance status, n (%)			.79
Public	51 (66)	56 (67)

Abbreviations: BMI, body mass index; TAFE, Technical and Further Education.

A patient was described as a smoker if they were smoking one or more cigarettes per month.

Table 2.

Twelve-Month Outcomes Comparing Individuals From the Randomized Cohort Who Were Lost to Follow-up vs Those Who Were Included in the Current Study.

Variable	Followed Up	Lost to Follow-up	P Value
FAOQ, mean (SD)	51.6 (8)	51.1 (9)	.70
PCS, mean (SD)	54.5 (6)	52.5 (8)	.07
MCS, mean (SD)	55.2 (12)	56.5 (9)	.61
Any adverse event, n (%)	16 (21)	17 (21)	.68
Major adverse event, n (%)	4 (5)	5 (6)	.65
Minor adverse event, n (%)	13 (17)	14 (17)	.68

Abbreviations: FAOQ, Foot and Ankle Outcomes Questionnaire; MCS, mental component summary; PCS, physical component summary.

The baseline demographics were similar between the surgical and nonsurgical groups at minimum 5-year follow-up as shown in Table 3.

Table 3.

Comparing Baseline Demographics Between the Surgical and Nonoperative Cohorts in Individuals with 5-Year Follow-up.

Variable	Surgical (n=40)	Nonsurgical (n=37)	P Value
Age, y, mean (SD)	37.1 (12.7)	42.8 (13.8)	.062
Female, n (%)	20 (50)	16 (43)	.55
BMI, mean (SD)	28 (5.4)	28.6 (6.4)	.61
Mechanism, n (%)			.098
Fall <1 m	36 (90)	29 (78)
Fall >1 m	4 (10)	4 (11)
Motor vehicle accident	0 (0)	4 (11)
Education, n (%)			.76
High school or lower	16 (40)	15 (41)
TAFE/diploma	15 (38)	16 (43)
University or above	9 (22)	6 (16)
Diabetes mellitus, n (%)	2 (5)	2 (5)	.94
Smoker, n (%)	14 (35)	9 (24)	.31
Working, n (%)	37 (93)	30 (81)	.14
Insurance status, n (%)			.68
Public	26 (65)	25 (69)

Abbreviations: BMI, body mass index; TAFE, Technical and Further Education.

At a minimum 5-year follow-up, the surgical group was not superior when compared with nonsurgical group in terms of ankle function and quality of life based on a 5-point minimum clinical difference. Patients in the surgical group were more likely to suffer adverse events when compared with the nonsurgical group (OR 3.7, 95% CI 1.2-11.6). A summary of the outcomes is presented in Table 4. A breakdown of the adverse events is shown in Table 5. Of the patients followed up at 5 years, 16 had reported adverse outcomes at 12 months (21%). This had risen to 20 adverse events (26%), an increase of 5%. These additional adverse events were all removal of hardware cases from the surgical cohort.

Table 4.

Results Comparing the Surgical and Nonoperative Cohorts in Those With 5-Year Follow-up.

Variable	Surgical	Nonsurgical	Difference (95% CI)	P Value
FAOQ, mean (SD)	51.7 (8)	49.6 (10)	2.1 (–2.1 to 6.2)^a	.95
PCS, mean (SD)	51.5 (8)	49.1 (10)	2.3 (–2.0 to 6.7)^a	.54
MCS, mean (SD)	52.0 (9)	52.6 (10)	0.54 (–4.8 to 3.7)^a	.61
Any adverse event, n (%)	15 (38)	5 (14)	3.7 (1.2-11.6)^b	.02
Major adverse event, n (%)	8 (20)	1 (3)	8.8 (1.03-73.9)^b	.02
Minor adverse event, n (%)	9 (23)	4 (11)	2.3 (0.7-8.3)^b	.19

Abbreviations: FAOQ, Foot and Ankle Outcomes Questionnaire; MCS, mental component summary; PCS, physical component summary.

Mean difference (95% CI).

Odds ratio (95% CI).

Table 5.

A Breakdown of Adverse Events Comparing the Surgical and Nonoperative Cohorts at Minimum 5-Year Follow-up.

Variable	Surgery	Nonsurgical	P Value
Return to operating theaters, n (%)	8 (20)	1 (2.8)	.02
Neurovascular injury, n (%)	3 (7.5)	1 (2.8)	.36
Major infection, n (%)	0 (0)	0 (0)	–
Minor infection, n (%)	6 (15)	1 (2.8)	.066
DVT, n (%)	0 (0)	2 (5.6)	.13

Abbreviation: DVT, deep vein thrombosis.

Discussion

In adult patients aged 18-65 years with an isolated type B ankle fracture and minimal talar shift, surgical management was not superior to nonsurgical management in terms of ankle function and health-related quality of life after a minimum of 5-year follow-up post injury. Although the patient-reported outcome scores were higher in the surgical arm than the nonsurgical cohort, we demonstrated a failure to reach the minimum clinical difference and therefore superiority. This is in keeping with the previous review of outcomes at 12 months post injury.¹⁷ The role of surgery needs to be supported by superior outcomes given the cost and risk of adverse events associated with surgery.

Adverse events were recorded in this study in a cumulative fashion. These followed the original definitions of major (unplanned/repeat surgery; major infection; pulmonary embolus, death, or other adverse event requiring hospital admission) or minor (neurologic injury not requiring further intervention; minor infection; deep vein thrombosis or other adverse events not requiring hospital admission). All patients were asked standardized questions to elicit these responses but were unable to differentiate complications within 12 months vs complications after 12 months.

In terms of adverse events, the overall number had increased since the 12-month report. Of the patients followed up at 5 years, 16 had reported adverse outcomes at 12 months (21%). This rose to 20 adverse events (26%) at 5 years, an increase of 5%. These additional adverse events were all removal of hardware cases from the surgical cohort. The rate of adverse events in this study is compatible with the overall rates of complication in ankle surgery in the literature, specifically open reduction internal fixation, which are reported to be as high as 40% for any adverse event.^12,16

The patient-reported outcomes in this study are comparable to other studies assessing long-term functional outcomes in patients with ankle fractures. Chong et al³ reported a mean Olerud-Molander Ankle Score (OMAS) and the Lower Extremity Functional Scale (LEFS) as 72 and 66, respectively, for patients with ankle fractures that were treated with operative fixation. (The range for OMAS and LEFS is 0-100 and 0-80, respectively; a higher score is better for both scores.) They included patients with OTA type A to C ankle fractures. Van Leeuwen et al²⁸ conducted a retrospective study assessing the long-term follow-up (mean 5.3 years post injury) of surgically and nonsurgically treated isolated OTA type B ankle fractures. They found that the OMAS was 84 for both the nonsurgical and surgical groups. They also found that 34.4% of patients needed a subsequent operation for removal of hardware.

It is important to note that the initial CROSSBAT study did not include testing for stability. Initial inclusion criteria did not necessitate nonweightbearing images, and no formal stress tests were performed. In Australia, it is not routine practice to obtain stress tests for these types of fractures. This study was a pragmatic study for evaluation of management based on an acute presentation. Weightbearing radiographs in the acute setting are not reliable because of pain. There is potential for “stress positive” injuries to have met the inclusion criteria for randomization and been included in the study. Despite this, both the 12-month and 5-year follow-up data demonstrated surgery was not superior to nonsurgical management, potentially supporting the nonsurgical treatment of such injuries, even in the absence of stress radiographs. Similar findings were noted by the Sanders et al trial where unstable injuries were included, based on stress radiographs. They found no functional differences between surgical and nonsurgical management.²³

This article was designed to assess the treatment of 44-B1 fractures at a population level. Although fractures in the context of other injuries were excluded to avoid inclusion of polytrauma patients, there was no subset analysis of the energy associated with the injury. The inclusion of tertiary facilities in this studies recruitment allows for high- and low-energy injuries to be included. However, given the randomization of this study, the results are unlikely to be significantly affected by the inclusion of these injuries.

Strengths and Limitations

The strengths of this study stem from its allocation concealment through the use of a third party overseeing the randomization and allocation. The outcome tools were validated and relevant while the assessors were anonymized. This is one of the longest RCT follow-up of patients with a type 44B1 ankle fracture treated with or without surgery. Karkkola et al¹⁰ reported on similar numbers in their assessment of stable and unstable ankle fractures over a 12-year period; however, this was a retrospective study.

A limitation of this study includes the high loss to follow-up. This notwithstanding, the demographics and 1-year results of those lost to follow-up were similar to those who were followed up, suggesting there was no systemic bias between the patients who were followed up and those who were not. The 12-month results of those lost to follow-up compared to the cohort included in this study demonstrate no significant difference. This was performed to address the potential risk of poorer outcome patients being preferentially lost to follow-up as reported by Murray et al.¹⁹

The loss to follow-up in this study was similar to other studies assessing longer term follow-up of patients with ankle fractures, highlighting the difficulty in long-term orthopaedic trials. Kohake et al¹¹ conducted a long-term follow-up of ankle fractures with a mean follow-up of 6.6 years; from 176 patients only 61 patients (35%) were followed up. Similarly, Roberts et al²² noted a loss to follow-up of 48% with a minimum 6-year follow-up in patients with ankle fractures, whereas van Leeuwen et al²⁸ had a loss to follow-up of 69% in patients with ankle fractures with a mean follow-up time of 5.3 years. The main criticism of the original CROSSBAT, and indeed all ankle fracture studies, has been a lack of long-term follow-up outcomes. This study addresses this deficiency while highlighting the difficulty in obtaining high follow-up rates in foot and ankle studies.

Another limitation was the lack of radiographs. The poor patient compliance with obtaining radiographs was noted with the initial CROSSBAT study and thus not included in the current study. The lack of anonymizing of the surgeon and the patient is another limitation but is unavoidable in this type of trial.

Conclusion

The results of this study suggest that in terms of patient-reported outcomes, surgical management is not superior to nonsurgical management in type B ankle (fibula) fractures with minimal talar shift over a 5-year period and that surgery is associated with increased adverse events.

Supplemental Material

sj-pdf-1-fai-10.1177_10711007221128562 – Supplemental material for Minimum 5-Year Follow-up Results: CROSSBAT (Combined Randomised and Observational Study of Surgery vs No Surgery for Type B Ankle Fracture Treatment)

Supplemental material, sj-pdf-1-fai-10.1177_10711007221128562 for Minimum 5-Year Follow-up Results: CROSSBAT (Combined Randomised and Observational Study of Surgery vs No Surgery for Type B Ankle Fracture Treatment) by Ryan O’Keefe, Justine M. Naylor, Michael J. Symes, Ian A. Harris and Rajat Mittal in Foot & Ankle International

Footnotes

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The authors report all support for the present article (eg, funding, provision of study materials, medical writing, article processing charges, etc) from the AOA Research Foundation. ICMJE forms for all authors are available online.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Australian Orthopaedic Association Research Foundation, Grant 365.

ORCID iDs

Ryan O’Keefe, MBBS,

Michael J. Symes, MBBS, FRACS, MPH,

Ian A. Harris, MBBS, MMed(Clin Epi), PhD, FRACS,

Rajat Mittal, PhD, FRACS,

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Supplementary Material

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