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Abstract

Ankle fracture surgeries are common orthopaedic procedures. Fibular fixation is often an important component in restoring ankle stability. Fibular intramedullary nailing (fIMN) has gained recent interest as an alternative technique to fibular plating. This systematic review and meta-analysis was performed to compare the outcomes of fibular nailing versus fibular plating for all current available literature. A PRISMA-compliant systematic review was conducted across MEDLINE/Pubmed, Cochrane, and Embase databases for cohort and clinical trial studies comparing outcomes of fibular nailing and fibular plating of ankle fractures. Demographics and results of the studies were extracted from the articles. Outcomes of interest extracted included operative time, functional outcomes scores, hardware/loss of reduction, malunion/nonunion, re-operations, and wound complications. Meta-analysis of included studies used odds ratios and standardized mean difference when appropriate. Nine studies were included in this systematic review. Eight studies were then used for meta-analysis comparison. fIMN showed equivalent operating times to fibular plating. fIMN had equivalent outcomes when compared with fibular plating for hardware failure/loss of reduction, Olerud and Molander Ankle Score, malunion/nonunion, and re-operations. Fibular nailing showed a decrease in wound complications (OR: 0.35 [0.18, 0.66] (p = .001)) when compared with fibular plating. fIMN showed equivalent outcomes and decreased wound complications compared to fibular plating. fIMN is a safe and effective alternative treatment method that can be used by surgeons to treat distal fibula fractures.

Level of Evidence

Keywords

fibula fracture plating intramedullary nail weber classification

Introduction

Ankle fractures are one of the most common orthopaedic injuries, with thousands undergoing surgical fixation annually.^1,2 These fractures often involve (in isolation or in some combination of) the medial and posterior malleoli of the tibia, the distal aspect of the fibula, and the distal tibia-fibula syndesmosis.^1,3,4 These structures are all crucial in providing stability to the ankle joint, which is essential for weight bearing, ambulation, and basic daily function.^1,3,4 Many ankle fractures meet indications for surgical repair due to instability of the ankle mortise caused by the fracture.^5,6 Accurate restoration of these critical structures is crucial for preventing loss of ambulation and potential future complications, such as post-traumatic arthritis.^5,7,8

Distal fibula fracture fixation strategies are of particular interest when treating ankle fractures.^5,6 Fixation of fibula fractures has commonly been completed with open reduction and internal fixation (ORIF) through a lag screw and neutralization plating, bridge plating, antiglide plating, or other plating constructs.^9,10 Some authors contend that fibular plating remains the gold standard for fixation of distal fibula fractures.¹¹ Another treatment is intramedullary screw fixation of the distal fibula, which yields comparable outcomes to traditional plating, along with the advantage of fewer delayed implant removals (with its own unique set of downsides such as decreased ability to perform syndesmotic fixation).¹² All of these treatments have shown overall high rates of union, positive outcome scores, and low complication rates.^9–12 Another highly successful treatment in ankle fracture fixation is fibular intramedullary nailing (fIMN).^5,9,13

fIMN is theorized to have several advantages over other treatment modalities, including smaller incisions, overall cost benefits, and endosteal fixation.^14,15 These potential advantages have led to a rapid expansion in the use of fIMN. In the event of a concomitant syndesmotic injury, current fIMN systems allow for the placement of syndesmotic screws or suture buttons to achieve syndesmotic fixation.⁹ The purpose of this systematic review and meta-analysis was to evaluate all available current literature on fIMN and to compare outcomes with traditional plating techniques. To our knowledge, this is the first systematic review to evaluate all literature, and not strictly randomized trials. Evaluating the non-inferiority of fIMN compared to fibular plating is important in demonstrating safety and justification for its use. The authors of this study hypothesize that fIMN will have equivalent outcomes when compared with fibular plating techniques.

Methods

Study design

This research activity was determined to be exempt or excluded from Institutional Review Board oversight in accordance with current regulations and institutional policy. This systematic review followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) statement standards.¹⁶

Eligibility criteria

Studies were eligible for inclusion if they met the following criteria: (1) Cohort study or clinical trial comparing fibular plating vs fibular intramedullary nailing for ankle fractures (2) Was not a cadaveric study, (3) Manuscript was completed in English, (4) Studies were completed on or after January 1, 2000. Reviews, commentaries, letters to the editor, technique papers, and surveys were excluded.

Search strategy

PubMed/MEDLINE, Cochrane, and Embase databases were systematically searched for publications from January 1, 2000 to June 18, 2024. Comprehensive search strategies were developed using a combination of keywords, MeSH terms, and synonymous terms. The PubMed/Medline search was adapted to the Cochrane and Embase databases. See supplemental table 1 for a complete Pubmed Search.

One author (T.B.P.) performed the search. Three authors (T.B.P., C.R.M, A.D.L.) excluded irrelevant articles and duplicates based on title and abstract. The remaining articles underwent an independent full-text review by three authors (T.B.P., C.R.M., A.D.L.) and were assessed for eligibility based on established criteria. Any conflicts were resolved by discussion among the three authors.

Data extraction

Study demographic information was collected including the following: Patients, age, sex, implant type, fracture type, outcomes, and study results.

Quality assessment

The Cochrane risk of bias 2 (ROB-2) for randomized control trials tool was used to assess all randomized control trials for bias.¹⁷ The ROB-2 is composed of five domains which evaluates bias within randomized clinical trials. The bias is classified into three categories: high, some concern, and low. An overall bias assessment is produced upon the combination of the five domains.

The methodological quality of the nonrandomized studies included in the review was evaluated using the Methodological Index for Non-Randomized Studies (MINORS) Criteria.¹⁸ The MINORS Criteria uses a validated 12-item checklist to ensure a critical appraisal of the study design through a standardized assessment. Three items were not applicable due to the retrospective cohort studies (i.e., prospective collection of data, loss to follow-up, prospective calculation of study size). A maximum of 18 points is possible for retrospective comparative studies, and studies with scores between 12 and 18 were considered high quality.

Statistical analysis

A meta-analysis was performed to compare fibular plating versus fIMN for the following outcomes: wound complications, defined as any occurrence of surgical site infection (SSI) or wound necrosis; hardware failure/loss of reduction; re-operations; malunion/nonunion; and Olerud & Molander score. These comparisons were analyzed with Mantel-Haenszel odds ratio (OR) estimates with 95% confidence intervals for dichotomous variables. A standardized mean difference (SMD) was used to compare continuous variables via a mean and standard deviation. Forest plots included studies with zero total events to maintain analytic consistency.¹⁹ Heterogeneity was reported using the I² statistic. Random and fixed effect models were used appropriately when the I² statistic value was over and under 50%, respectively. A p value of less than 0.05 was considered statistically significant. Meta-analysis was performed using Cochrane’s Review Manager (RevMan, Version 5.4.1. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014).

Results

PRISMA flow diagram

A preliminary search of three databases provided a total of 229 studies. 32 duplicates were removed. 187 abstracts and titles were screened, and 103 were removed for lack of relevance. 84 reports were sought for retrieval. All reports were obtained. Nine studies met the final inclusion criteria and were incorporated in this review. Eight studies met inclusion for meta-analysis. See Figure 1.

Figure 1.

PRISMA flow diagram.

Study treatment, implants, and fracture classification

This review contained three level 1 evidence studies, four level 2 evidence studies, and two level 3 evidence studies.^20–28 The most commonly used intramedullary nail was a distally interlocked nail. The most common type of ORIF construct was a lateral locked plate. Studies used a combination of ways to describe fractures, including anatomic locations, Weber classification, and the Lauge-Hansen classification. All prospective studies had a 1-year follow-up, except for Gangwar et al., which had an unspecified study length (Table 1).^{20,22,25–27}

Table 1.

Study treatment, implants, and fracture classification.

Study treatment, implants, and fracture classification
		ORIF			fIMN
Author and origin	Study design (level of evidence)	Number of patients (n)	Type of plate	Fracture type (n)	Number of patients (n)	Brand of fIMN	Fracture type (n)	Follow-up length or study period
Asolum et al., 2014 (France)	Randomized prospective cohort (level II)	35	Locking compression plate	Lateral malleolar: 6 Bimalleolar: 24 Trimalleolar: 12	36	Epifisa	Lateral malleolar: 12 Bimalleolar: 12 Trimalleolar: 5	1 year
Backer et al., 2020 (United States)	Retrospective comparative cohort (level III)	20	Unspecified	Lateral malleolar: 8 Bimalleolar: 11 Trimalleolar: 1	20	Arthrex	Lateral malleolar: 8 Bimalleolar: 11 Trimalleolar: 1	February 2018-August 2018
Badenhorst et al., 2020 (South Africa)	Randomized prospective controlled trial (level I)	22	Anatomical locking plate	Weber B: 21 Weber C: 1	29	Accumed	Weber B: 17 Weber C: 10	1 year
Chen et al., 2023 (China)	Randomized prospective study (level II)	39	Locking plate	SER type 4	42	Unspecified	SER type 4	1 year
Gangwar et al., 2023 (India)	Prospective comparative study (level II)	42	Unspecified	Lateral malleolar: 20 Bimalleolar: 17 Trimalleolar: 5	42	Unspecified	Lateral malleolar: 18 Bimalleolar: 16 Trimalleolar: 8	Unspecified
Kho et al., 2020 (Korea)	Prospective comparative study (level II)	31	Locking plate	Unspecified	30	Accumed	Unspecified	1 year
Tas et al., 2022 (Netherlands)	Retrospective cohort study (level III)	45	Unspecified	Lateral malleolar: 6 Bimalleolar: 10 Trimalleolar: 29	13	Accumed	Lateral malleolar: 2 Bimalleolar: 7 Trimalleolar: 4	January 2017-January 2019
White et al., 2016 (United Kingdom)	Randomized prospective controlled trial (level I)	50	Unspecified	Unstable ankle fractures	50	Accumed	Unstable ankle fractures	1 year
White et al., 2022 (United Kingdom)	Randomized prospective controlled trial (level I)	62	Stainless steel plate used in bridging, buttress, or neutralization	SER: 54 (87.1) PER: 2 (3.2) PAB: 5 (8.1) Unknown: 1 (1.6)	63	Unspecified	SER 49 (77.8) PER 7 (11.1) PAB 6 (9.5) Unknown 1 (1.6)	1 year

Study demographics and outcomes

Patients included in the systematic review ranged from 40.4 to 82.5 years.^20–28 All studies showed high union rates above 90% with both plating and fIMN.^20–28 The Olerud and Molander Ankle Score (OMAS) was the most common functional outcome measure. Backer et al, showed that fIMN had a lower mean tourniquet time than plating; however, that difference was not statistically significant (Table 2).²¹

Table 2.

Study demographics and outcomes.

Study demographics and outcomes
Author	Treatment	Age (mean ± SD)	Sex, female (%)	Union rate	Functional outcome scores used	Complication rate (%)	Other results
Asolum et al., 2014	ORIF	52.2 (20.47)	50%	93.80%	OMAS Kitaoka score	56.25%	Nailing had improved Kitaoka scores (p = .0011) Nailing had higher Olerud-Molander ankle score (p < 0.0001)
Asolum et al., 2014	fIMN	54.8 (17.9)	44.80%	100%	OMAS Kitaoka score	7.14%
Backer et al., 2020	ORIF	41.8	NR	NR	N/A	NR	Nail fixation had mean tourniquet time of 68.9 minutes and plating had mean tourniquet time of 75.8 minutes (p = .37)
Backer et al., 2020	fIMN	52.5	75.00%	95%	N/A	0%
Badenhorst et al., 2020	ORIF	42.9 (13.9)	72.70%	100%	OMAS Grimby score	4.5	Nailing had a significant decrease in scar size (p < .001) and screening time (p < .001). No differences existed between functional and PROM measures (p > 0.05)
Badenhorst et al., 2020	fIMN	42.8 (13.8)	55.20%	100%	OMAS Grimby score	0
Chen et al., 2023	ORIF	49.54 (7.76)	51%	95%	AOFAS	30.80%	No differences existed between bone healing time, operation time, AOFAS score, VAS score, and functional evaluations (p > 0.05)
Chen et al., 2023	fIMN	52.83 (8.17)	47%	100%	AOFAS	9.52%
Gangwar et al., 2023	ORIF	NR	54.80%	100%	NR	11.90%	Nailing had significantly higher rates of wound infection, wound dehiscence, and screw breakage (p < 0.05)
Gangwar et al., 2023	fIMN	NR	47.60%	98%%	NR	21.40%
Kho et al., 2020	ORIF	48.1 ± 18.5	51.60%	100%	AOFAS OMAS	32.30%	Nailing had a significant increase in AOFAS and OMAS scores at 3 months (p < .001) and 6 months (p = .0177), and lower overall postoperative complications (p = .0227); No significant differences existed in AOFAS and OMAS scores at 9 months and 12 months (p > 0.05)
Kho et al., 2020	fIMN	49.6 ± 16.5	53.30%	100%	AOFAS OMAS	13.30%
Tas et al., 2022	ORIF	71.4 (5.0)	81%	100%	NR	33%	No significant difference existed in postoperative complications between nailing and plating (p > 0.05)
Tas et al., 2022	fIMN	82.5 (10.2)	92%	100%	NR	15%
White et al., 2016	ORIF	74	78%	98%	OMAS	34%	Nailing had a significant decrease in infection (p = .002); No significant difference existed in mean functional scores or scar satisfaction ([>.05)
White et al., 2016	fIMN	74	72%	98%	OMAS	10%
White et al., 2022	ORIF	42.8 (12.9)	50%	100%	OMAS	29%	No significant difference existed in mean functional scores, infection rate, overall complications, or re-interventions (p > 0.05)
White et al., 2022	fIMN	40.4 (14.1)	50.80%	100%	OMAS	28.60%

Quality analysis results

MINORS criteria quality assessment was completed on all studies that were not Level 1 double blind randomized control trials. All studies except Gangwar et al., were considered to be high quality studies by the MINORS criteria quality assessment. See Table 3. ROB-2 was evaluated for all Level 1 double blind randomized control trials. White et al., 2016 and White et al., 2022 were of low concern for bias. Badenhorst et al., was of some concern for study bias. See Table 4.

Table 3.

MINORS criteria quality assessment of non-randomized studies [Items are scored as 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate)].

MINORS criteria quality assessment
Criteria	Asolum et al., 2014	Backer et al., 2020	Chen et al., 2023	Gangwar et al., 2023	Kho et al., 2020	Tas et al., 2022
Clearly stated aim	2	2	2	2	2	2
Inclusion of consecutive patients	2	1	2	1	2	2
Appropriate endpoints	2	2	2	2	2	2
Unbiased assessment endpoints	1	1	2	1	2	2
Appropriate follow-up	1	1	2	1	2	1
Adequate control group	2	1	2	1	1	2
Contemporary groups	2	1	2	1	1	2
Baseline equivalence of groups	1	1	1	1	2	1
Adequate statistical analysis	2	2	2	1	2	2
Cumulative MINORS score	15	12	17	11	16	16

Table 4.

Risk of Bias tool for randomized trials (ROB-2) plot.

Meta-analysis

Wound complications analysis included eight studies which showed a statistically significant decrease in wound complications for fIMN when compared with ORIF with fibular plating (OR: 0.35 [0.18, 0.66] (p = .001)) (Figure 2). Loss of reduction/hardware failure analysis included eight studies which showed equivalent results for fIMN when compared with ORIF with fibular plating (OR: 0.47 [0.18, 1.25] (p = .13)) (Figure 3). Re-operation analysis included four studies which showed equivalent results for fIMN when compared with ORIF with fibular plating (OR: 0.65 [0.35, 1.22] (p = .18)) (Figure 4). Malunion/non-union analysis included seven studies which showed equivalent results for fIMN when compared with ORIF with fibular plating (OR: 0.68 [0.19, 2.48] (p = .56)) (Figure 5). OMAS score analysis included five studies which showed equivalent results for fIMN when compared with ORIF with fibular plating (OR: 3.02 [−2.50, 8.55] (p = .28)) (Figure 6).

Figure 2.

Wound complication analysis (Includes: Superficial SSI, Deep SSI, and wound necrosis).

Figure 3.

Loss of reduction and hardware failure.

Figure 4.

All Re-operations.

Figure 5.

Malunion/nonunion.

Figure 6.

Olerud & Molander ankle score.

Discussion

fIMN was found to have equivalent outcomes to fibular plating when comparing Olerud and Molander Ankle score, malunion/nonunion, hardware removal/loss of reduction, and all re-operations. This study also found that operative time was equivalent for fibular nailing when compared with fibular plating.²¹ fIMN was found to have a statistically significant decrease in wound complications when compared to fibular plating. This is the first systematic review and meta-analysis to our knowledge to evaluate all current comparative literature available when comparing fIMN versus fibular plating.

fIMN could be particularly of benefit with patients at high risk of wound complications. Some of these patient risk factors include diabetes, immunocompromise, injuries where additional nearby incisions are required (such as in pilon fractures), and in ankle fractures with soft tissue swelling.^29,30 fIMN incisions are typically much smaller in size,³¹ which could be the primary driver for decreased wound complications. Surgeons can effectively use this information in their preoperative planning to determine the most effective treatment for their patients, as these benefits could have a significant impact on the care of patients with fibula fractures.

While this study has shown that there are positive effects of fIMN, one potential concern is the cost of the implant when compared with plates and screws. Nailing has been proposed to decrease overall healthcare costs, as demonstrated in previous studies that evaluated cost benefit.¹⁵ Peeperkorn et al., found that the median costs of fIMN implants to patients was $703 United States dollars (USD), and plates were $456 USD.¹⁵ However, when comparing the overall median costs of treatment per patient, they found that fIMN cost $6444 USD and plating $7071 USD.¹⁵ When they compared staged plating versus early fIMN, they found that early fIMN costs to the patient was $6298 USD and plating was $15,014 USD.¹⁵ A second concern is the limited number of companies who currently offer fibular intramedullary nail implants. Access to these implants may be difficult for patients living in some locations due to lack of surgical services.³² A third consideration is the learning curve associated with (for some surgeons) an unfamiliar fixation technique.³³

fIMN remains a relatively less common approach for fixation of fibula fractures. Future studies should evaluate the large-scale use of this device type with longitudinal outcomes to further evaluate the effects of fIMN. Future studies should also evaluate a complete cost analysis to determine episode-of-care costs associated with fIMN versus plating. At this point in time, fIMN is a safe and effective approach for fixation of fibula fractures. Surgeons can confidently use these implants in the operating room with literature to support their effectiveness.

Limitations

This study was not without limitations. There was the potential for missed literature; while our search was comprehensive and searched three major literature databases, it was possible that literature in another language or in a different database exists. Another potential limitation was that this study did not examine elastic fibular nails or intramedullary screws for similar efficacy. However, this study solely evaluated comparative studies regarding intramedullary fibular nail fixation versus traditional fibular plating, and therefore those investigations would be better evaluated in a separate study. A third limitation is the variations in comorbidities and fracture types. This was not evaluated due to variations within the literature and unclear reporting of these factors throughout some studies. Future clinical studies can prioritize these within their results. A fourth limitation is the wide age range of patients in the systematic review, with patient ages ranging from 40 to 80+ years of age. Two studies, Tas et al., 2022 and White et al., 2016 favor fIMN in the elderly population.^26,27 These two studies may mask the outcomes of fIMN in younger populations, and is certainly a limitation of the current available literature. Future studies can evaluate fIMN by age. A fifth limitation is that our study evaluated all comparative literature, including older generation fibular nails, such as the nail used in Asolum et al., which lacks locking options or syndesmotic stabilization options.²⁰ These nails previously showed increased complications such as hardware migration, loss of reduction, and malunion.⁹ This study may mask the true effect of the current nailing systems. As more literature becomes available on modern fibular nailing systems, future studies evaluating comparative literature can remove older generation nails. The fourth and fifth limitations of this study could contribute some potential bias to our study results. A final limitation is the potential variation in the different types of nail and plate systems used. These potential variations in products have not been evaluated in a comparison study clinically, and therefore differences remain unknown at this time.

Conclusions

fIMN showed mostly equivalent outcomes with the addition of decreased wound complications when compared with fibular plating. fIMN is a safe and effective method to fix unstable fibula fractures.

Supplemental Material

Supplemental Material - Comparison of fibula plating versus fibula nailing: A systematic review with meta-analysis of all current comparative literature

Supplemental Material for Comparison of fibula plating versus fibula nailing: A systematic review with meta-analysis of all current comparative literature by Troy B Puga, McKenna W Box, Charles R Marchese, Alan Lam, Sam Stegelmann and John T Riehl in Journal of Orthopaedic Surgery

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 of this study have no conflicts of interest to disclose. JTR is a consultant for and receives royalties from Arthrex Inc. The remaining authors have no potential competing interests to disclose.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

HCA Healthcare Disclaimer

This research was supported (in whole or part) by HCA Healthcare and/ or an HCA Healthcare-affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any affiliated entities.

Ethical statement

ORCID iD

Troy B Puga

Supplemental Material

Supplemental material for this article is available online.

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, et al. Minimal-invasive Osteosynthese von distalen Fibulafrakturen mittels Marknagels [Minimally invasive fixation of distal fibular fractures with intramedullary nailing]. Operat Orthop Traumatol 2021; 33(2): 104–111. DOI: 10.1007/s00064-021-00702-1.

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