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Journal of Clinical Orthopaedics and Trauma logoLink to Journal of Clinical Orthopaedics and Trauma
. 2024 Mar 21;51:102395. doi: 10.1016/j.jcot.2024.102395

Management of non-unions of the malleolar fractures- Current Evidence

Chin Yik Tan a,, Gowreeson Thevendran b
PMCID: PMC10988033  PMID: 38577563

Abstract

Although malleolar non-union is uncommon, it is associated with significant morbidity. Managing this problem requires understanding ankle fracture biomechanics and bone healing. We present in this article the pertinent points to be considered in evaluating and managing patients with malleolar non-union. Our discussion will focus on the important risk factors contributing to this problem, and the need to carefully consider the biomechanical stability and the biological environment to ensure successful bony unions.

1. Introduction

A non-union occurs when a fracture fails to heal within an expected time frame and the biological mechanisms of bone healing do not progress as expected.1 There are several definitions of non-union but the Federal Drug Administration (FDA) definition is generally accepted. According to the FDA definition, a non-union can be established after a minimum of 9 months with no visible signs of healing for at least 3 months.2

Non-union following a malleolar fracture can lead to significant morbidity and a higher risk of posttraumatic osteoarthritis.3 Considering the lack of data on this topic and its associated complications, it becomes even more prudent to share a literature review on malleolar non-union that describes both its basic science and treatment. The purpose of this article is to discuss the biomechanical and biological aspects of this problem, as well as how we can apply this knowledge to the evaluation and management of patients with this condition. Ultimately, the objective is to increase the readers' knowledge, awareness, and ability to make informed decisions about this issue.

2. Epidemiology and etiology

While the non-union rate for all fractures has been reported to be 5–10% in several studies,4 malleolar non-union is infrequently reported.5,6 Donken et al.7 reported a non-union rate of 2.1% in 388 patients treated non-operatively for malleolar fractures and found most cases of non-union happened due to instability in the initial radiographs. While instability is a common non-union etiology, surgeons must consider other etiologies or risk factors contributing to malleolar non-union. Lavery et al.8 found the odds ratio of diabetic patients developing non-union was 6.5 compared to non-diabetic patients. Other risk factors quoted in the same paper include dialysis, steroid use, fracture severity, and infection. Soft tissue interposition such as the periosteum, deltoid ligament, or posterior tibialis tendon in cases of medial malleolus fractures may also contribute to non-union.

3. Anatomy and biomechanics

Evaluation of fracture stability is essential with both acute fractures and non-union cases. Evaluating ankle fracture stability using a "ring model" is useful. As illustrated in Diagram 1, the ankle joint's cross-section can be seen as a ring that provides ankle stability. Some structures make up the ring: the lateral malleolus laterally, the anterior inferior tibiofibular ligament anteriorly, the medial malleolus and deltoid ligament medially, and the posterior malleolus and posterior inferior tibiofibular ligament posteriorly. The ankle joint will become unstable if there is a disruption to 2 or more sites of this ring, resulting in a greater chance of a non-union.9 Additionally, the stability of the medial column, which consists of the deltoid ligament and the medial malleolus, plays an important role in fracture stability. A biomechanical study10 found that when the deep deltoid was sectioned, there was demonstrable instability in all specimens with ankle fractures. Unstable acute fractures should be diagnosed using stress radiographs such as weight-bearing radiographs and treated operatively.11

Diagram 1.

Diagram 1

The ring model. A: lateral malleolus, B: anterior inferior tibiofibular ligament, C: medial malleolus and deltoid ligament, D: posterior malleolus and posterior inferior tibiofibular ligament.

Deformities affecting the lower limbs may cause an asymmetrical distribution of stress, leading to stress fractures as well as non-unions.12 At the ankle joint, body weight forces are axially transmitted through the tibia and fibula onto the talus, and changes in alignment will cause disproportionate stress on the malleoli. A biomechanical study by Calhoun13 had shown that when the ankle was moved to inversion, there was an increase of force on the medial talus facet and medial malleolus, and the opposite was true for an eversion effect on the lateral malleolus. In other words, any deformity or loss of alignment, such as from fractures or other congenital/acquired deformities, will result in increased stress on the malleoli with an increased risk of non-union. Surgeons planning to definitively treat malleolar non-union should always consider the possibility of malalignment contributing to treatment failure.

4. Pathophysiology of non-unions

Bone healing involves a series of events at the molecular and cellular levels. Giannoudis et al.14 described the diamond concept, which categorized the important factors for bony healing into 4 groups including growth factors, osteogenic cells, osteoconductive scaffolds, and mechanical environments. During fracture healing, hematomas form and cytokines are released locally. These cytokines include growth factors important for bone healing, such as Transforming Growth Factor β, Vascular Endothelial Growth Factor, Platelet-Derived Growth Factor, and Insulin-like Growth Factor.15 Concurrently, there is also the recruitment of multipotent mesenchymal cells to the fracture site, followed by transformation to cells with osteogenic properties.16 An extracellular osteoconductive scaffold provides the environment for these processes. Appreciation of these factors is imperative in the understanding of non-union pathophysiology.

5. Classification

In general, non-unions are categorized into four types: hypertrophic non-union, atrophic non-union, oligotrophic non-union, and septic non-union.17 Hypertrophic non-union occurs with abundant callus formation in a good biological environment, but there is a lack of stability. In contrast, atrophic non-unions can occur when a poor biological environment prevents callus formation. Oligotrophic non-union involves incomplete callus formation and is often due to inadequate reduction and malalignment. Septic non-union involves infection that reduces blood flow and nutrition needed for bone formation.

6. Diagnostic evaluation

Assessment of patients will include the identification of underlying risk factors. A thorough history should include an evaluation of smoking status, obesity, diabetes mellitus, nutrition, and use of medications such as steroids. During the physical examination, surgeons should check for peripheral vascular disease, deformities of the lower limbs, and soft tissue status at the fracture site. A laboratory evaluation should include inflammatory markers for infection like white cell count, C-reactive protein, and erythrocyte sedimentation rate, as well as nutritional markers like albumin and Vitamin D levels. An effective radiographic evaluation of X-rays and CT scans should consider fracture pattern, comminution, callus formation, reduction, and stability of previous fixations.

7. Conservative management

A patient-specific treatment plan should be developed with consideration for individual risk factors for malleolar non-union. Among these are infection control, correction of deformities, vascular consults for peripheral vascular disease, plastic surgical consults for soft tissue problems, smoking cessation, diabetes control, and optimizing nutrition status.

Options for non-invasive bone stimulations include pulsed ultrasound, direct current, and shockwave treatments. Pulsed ultrasound and direct current therapies were shown to increase alkaline phosphatase activity and bone mineralization in in-vitro studies.18,19 In a review of the shockwave therapies in foot and ankle non-union, Iris et al.20 found good union rates (65–100%) following shockwave therapies in a few small sample case series. For most non-invasive bone stimulations, there is a lack of large randomized controlled trials with clinical outcomes to confirm their efficacy.

8. Surgical interventions

The following steps should be taken when developing a surgical treatment plan:

  • 1.

    Gentle soft tissue handling with minimal periosteal stripping.

  • 2.

    Removal of interposed soft tissue at bony ends.

  • 3.

    Preparation of bony ends to promote healing.

  • 4.

    Direct reduction of fracture ends.

  • 5.

    Biological augmentation if indicated.

  • 6.

    Biomechanical stabilization.

  • 7.

    Evaluation and stabilization of the syndesmotic joint.

9. Biomechanical stabilization

This section discusses alternative fixation methods for the medial malleolus, posterior malleolus, and lateral malleolus fractures and compares their biomechanical stability.

The fixation of medial malleolar fractures can be done in a variety of ways, with lag screws being the most common. Prior studies have examined screw orientations (divergent, parallel, and convergent), as well as screw numbers (1 and 2) in primary medial malleolar fractures.21,22 However, in the setting of a non-union, it is crucial to consider a biomechanically stiffer construct. One study has found that antiglide plates provided stiffer fixation compared to unicortical or bicortical screws in vertical fracture patterns.23 Another study comparing the hookplate and a lag screw found a shorter time to union and a lower rate of revision procedures in the hookplate group. The authors suggested that hookplate (Diagram 2) should also be considered in cases with comminution and the elderly with osteopenic bone.24

Diagram 2.

Diagram 2

The use of medial malleolus hookplate in osteopenic bone with comminution.

Studies have compared AP (Anterior to Posterior) screws, PA (Posterior to Anterior) screws, and posterior buttress plates for the fixation of posterior malleolar fractures (Diagram 3). It was found that the posterior buttress plate was biomechanically the most stable fixation and produced superior clinical outcomes.25,26,27 However, in a recent publication by Mansur et al.,28 the PA screw was found to be a biomechanically better fixation than the buttress plate. According to the authors, the differences in results were due to different types of plates used. Unlike other studies, Mansur et al.'s study utilized one-third tubular plates, whereas others used locking plates, likely accounting for the difference in biomechanical stiffness of the fixation.

Diagram 3.

Diagram 3

Types of posterior malleolus fixation: A: Anterior to Posterior screws, B: Posterior to Anterior screws, C: posterior buttress plate.

Several studies have evaluated lateral malleolus fractures to determine how biomechanical stability of locking periarticular plates compared with non-locking or one-third tubular plates. In studies with normal bone density, no difference had been found between the two plate types.29,30 However, in osteoporotic fractures, the locking plate was found to be biochemically stronger than one-third tubular plates,31,32 especially for rotational stability. In cases of non-union with disuse osteopenia and bone loss, the use of a periarticular locking plate (Diagram 4) may provide improved stability and therefore better outcomes.

Diagram 4.

Diagram 4

The use of lateral malleolus locking plate in osteoporotic bone.

In cases of severe osteoporosis and fracture comminution, where surgeons may expect a high risk of fixation failure, we should consider a circular external fixator (Diagram 5). The use of a circular external fixator comes with the benefits of early weight bearing33 and reduced local soft tissue violation. It is also a good option in cases of infection and poor local soft tissue. However, there are issues with pin site infection and patient tolerance with an external fixator till the fracture unites.

Diagram 5.

Diagram 5

Use of circular external fixator in cases with a high risk of implant failure and poor local soft tissue condition.

10. Biological augmentation

Biological augmentation is crucial in cases of atrophic non-union and bone loss. Biological augments should be considered concerning their osteogenic, osteoinductive and/or osteoconductive properties.

Autologous bone graft is considered the gold standard with osteogenic, osteoinductive, and osteoconductive properties.34 However, surgeons need to consider the site of bone graft harvesting carefully. Grafting from distal sites such as calcaneum or tibia is technically easier and may reduce pain compared to the iliac crest, but the quality of bone graft from distal sites is of inferior quality, with studies showing less osteogenic cells in tibia and calcaneum bone grafting compared to iliac crest bone grafting (Diagram 6).35,36 Given the morbidity associated with autologous bone grafting, bone marrow aspirate becomes a viable alternative option. Bone marrow aspirate (Diagram 7) is osteogenic with mesenchymal stem cells and osteoinductive with growth factors, but lacks osteoconductive properties.37 A study of bone marrow aspirate in diabetic distal tibia and ankle fracture non-union found 82% healing rate and low number of complications compared to iliac bone grafting. Whenever bone loss is minimal, bone marrow aspirate could be a more attractive option in comparison to autologous conventional bone grafting.

Diagram 6.

Diagram 6

Iliac crest bone grafting.

Diagram 7.

Diagram 7

Bone marrow aspirate.

Allograft can be used to fill bone defects and has both osteoconductive and osteoinductive properties, depending on their preparation techniques. Several studies had shown the effectiveness of allograft in foot and ankle arthrodesis.38,39 Allograft however comes with potential risks of disease and infection transmission.40 Another option to allograft is DBM (Demineralized Bone Matrix) which is a bone product, also with both osteoconductive and osteoinductive properties, and the presence of Bone Morphogenic Proteins (BMP).41 DBM can exist in several forms such as paste, structural blocks, and sheets. DBM is comparable to allograft, as both have similar biological properties. The major differences include negligible risk of disease transmission in DMB compared to allograft, though DBM is significantly more expensive.42

BMP as part of the Transforming Growth Factor β family plays a role in the differentiation of stem cells into osteoblast, with BMP-2 and BMP-2 being extensively studied and available in clinical application.43 A study that investigated the role of BMP-2 in fracture non-union and high-risk arthrodesis found a 92% union rate and no difference when allograft or autograft supplementation was used.44 Another study in 112 cases of high-risk ankle and hindfoot arthrodesis found a union rate of 96% at an average union time of 11 weeks.45 In contemplating the use of BMP, surgeons need to counsel the patients on the theoretical risk of malignancy, with BMP suggested to play a role in the osteoinductive activity of prostate metastases.46 However, several studies had shown no clinical evidence to support the risk of malignancy in BMP use.47,48

11. Post-operative care and rehabilitation

Post-operative progression of rehabilitation should depend on the stability of fixation, bone quality, and surgeons’ preferences. For cases of non-union, it is reasonable for surgeons to be more cautious to reduce the risks of further complications. We prefer immobilization in a splint for 2 weeks, non-weight bearing for 6 weeks followed by weight bearing in a walker boot for another 6 weeks. There should be proper post-operative care such as deep vein thrombosis prophylaxis, adequate pain relief, wound care, swelling control, and range of motion exercises.

12. Complications and outcomes

There are very few studies published on outcomes of malleolar non-union. In a study of 15 patients with non-union,49 the authors found all cases of non-union went on to unite after surgery. The average time to union was 5.2 months after surgery. They also found similar functional outcomes in patients who were operated on for non-union and patients who underwent surgery for acute ankle fractures. The authors concluded that surgery in malleolar non-union led to reliable bone healing.

13. Emerging technologies and future directions

There is increasing research on the understanding of molecular mechanisms in non-union and the differential gene expression between non-union and fracture healing. Several genes such as Fibronectin-1, Thrombospondin-1, and Biglycan were identified as target genes for non-union treatments.50 The use of mRNA in a stable delivery platform has been shown to improve osteogenic markers and prolong transfection in fracture healing.51 Future directions include the modulation of gene expressions in human studies and the development of tailored gene treatment strategies for non-union cases.

14. Conclusion

Malleolar non-union is an uncommon problem but is associated with significant morbidity. An understanding of ankle fracture biomechanics and bony healing is crucial for managing this problem. During the assessment of patients, underlying risk factors for non-union should be considered and subsequent treatment should be tailored to each patient. The biomechanical stability and the biological environment should be carefully considered to ensure a successful union.

CRediT authorship contribution statement

Chin Yik Tan: Conceptualization, Methodology, Writing – original draft, Visualization. Gowreeson Thevendran: Resources, Writing – review & editing, Supervision.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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