- Email: [email protected]
Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly
G Model FAS 1052 No. of Pages 4
Foot and Ankle Surgery xxx (2017) xxx–xxx
Contents lists available at ScienceDirect
Foot and Ankle Surgery journal homepage: www.elsevier.com/locate/fas
Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly Sudhakar Rao Challagundla* , Sandeep Shewale, Calum Cree, Amanda Hawkins Department of Trauma & Orthopaedics, Dumfries and Galloway Royal Infirmary, Bankend Road, Dumfries DG1 4AP, United Kingdom
A R T I C L E I N F O
A B S T R A C T
Article history: Received 1 February 2017 Received in revised form 11 April 2017 Accepted 19 April 2017 Available online xxx
Background: Operative management of ever increasing ankle fractures in the elderly need a reliable system of internal fixation. We present results of one such fixation, Fibula Rod System. Methods: Patients who underwent Fibula Rod System were included. Fracture union rate, complications, time to weight bearing and patient satisfaction using FAAM score were studied. Results: The mean age of the fifteen patients included was 74 years. Satisfactory reduction was achieved and maintained in all. All fractures united. There were no infections. Complications included lack of purchase of distal AP screw (n = 1), fracture of fibula shaft (n = 1), failure to insert syndesmotic screws through zig (n = 2), delayed secondary wound healing (n = 1) and removal of metal ware (n = 2). At a mean follow-up of 12 months (n = 10 responses), median FAAM score was 91% (Interquartile range of 62%–99%). Conclusion: Fibula Rod System providing good stability and union, is a reliable operation for ankle fractures in the elderly. © 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Keywords: Fibula Rod system Ankle fracture Fibula intramedullary nail
1. Introduction Ankle fractures in the elderly population is not an uncommon injury and the incidence is on the rise [1]. Skin condition, osteoporosis, poor compliance with postoperative weight bearing regime and comorbidities renders management of these injuries complicated. Non-operative management has a substantial risk of loss of reduction [2]. Operative management has been shown to produce satisfactory results [3] and reduce mortality rates [4]. In this age group with poor skin condition, open procedures are fraught with problems including delayed wound healing and infection. Intramedullary fixation of lateral malleoli was conceptualized to address some of these issues. We present the results of fixation of lateral malleolus in ankle fractures using one such intramedullary device, Fibula Rod System (Acumed) [5].
system (PACS) were reviewed. The decision to operate and use Fibula Rod for lateral malleolus fixation was at the discretion of the treating surgeon. Internal fixation of medial and posterior malleoli was performed as deemed necessary by the operating surgeon. The operated ankle was immobilized in a below knee back slab in the immediate post-operative period and changed to a below knee cast when the swelling permitted. Post-operative regime of weight bearing in the below knee cast was based on surgeon’s intraoperative assessment of the stability of the fixation. Patients were followed up at 2 weeks and 6 weeks. Patients were discharged to physiotherapists at 6 weeks in uncomplicated cases and at the earliest safe opportunity in cases requiring further clinical supervision. Fracture healing rate, time to weight bearing and intraoperative and postoperative complications were studied. Patient’s satisfaction was assessed using Foot and Ankle Ability Measure (FAAM) outcome score through a postal questionnaire.
2. Materials and methods 3. Results All ankle fracture fixations where the Fibula Rod System (Acumed) (Fig. 1) was used to stabilize lateral malleoli in the last two years were included in this retrospective observational study. Case notes including accident and emergency notes, operation notes and radiographs on picture archiving and communication
* Corresponding author. E-mail address: [email protected] (S.R. Challagundla).
In total fifteen ankle fractures were treated with the Fibula Rod System for lateral malleoli stabilization during the study period. Of these majority (n = 12) were low energy injuries. There were four open and eleven closed injuries. The wounds in all the open injuries were on the medial side (Fig. 2). Five patients needed manipulation by ambulance crew or in Accident and Emergency for subluxation or dislocation. There were ten patients with supination external rotation (stage 4) injuries, three with
http://dx.doi.org/10.1016/j.fas.2017.04.015 1268-7731/© 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
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Fig. 1. AP and lateral views of ankle fracture treated with Fibula Rod System. Fig. 3. Unstable bimalleolar ankle fracture (a) treated with Fibula Rod alone (b).
Fig. 2. Open fracture with wound on the anteromedial aspect of ankle joint with tibia protruding through the wound.
pronation external rotation and one case each of pronation abduction and supination adduction. The mean age of the study population was 74 years (range 61–90). Most (n = 12) were in female patients and eight of injuries were on the right. Fracture fixation using the Fibula Rod System was done primarily. One patient who presented with community acquired pneumonia and open ankle fracture dislocation, died in ICU on the 3rd post-operative day and was included only for radiological analysis and not for clinical follow up. The operations were performed by 4 different surgeons under general (n = 12, 80%) or spinal anesthesia (n = 3, 20%). The American Society of Anesthesiologists (ASA) grade of these patients was grade 3 (mode). Along with Fibula Rod fixation of lateral malleoli fracture, patients also underwent fixation of medial malleolus with screws (n = 10), buttress plate (n = 1) and tension band wiring (n = 2). One patient underwent antero–posterior screw fixation for posterior malleolar fragment. In two patients, the condition of the skin over the medial side of ankle prevented fixation of medial malleolus fracture. The surgeon was satisfied with the reduction of medial malleolus and the stability of the ankle following the insertion of Fibula Rod. Hence the medial side was left alone (Fig. 3a & b). The average tourniquet time (at 300 mmHg pressure) was 84 min (range 45–120 min). All patients received preoperative antibiotic prophylaxis and post-operative antibiotics (in open injuries) as per local protocol. Satisfactory reduction was achieved in all the cases using the technique described in the surgical technique manual for this
implant (Acumed). Intraoperative reduction was deemed satisfactory when the fibular length, alignment and ankle mortice (concentric joint space) was restored. The reduction in one patient was suboptimal with talus shift, when analyzed retrospectively. One patient had no distal antero-posterior screws inserted through the nail due to lack of purchase of the screws in the bone. One patient had fracture of fibula shaft at the tip of the Fibula Rod (Fig. 4a). Fracture occurred in the diaphyseal segment of fibula. In this patient, the ankle fracture and fibular shaft fracture went on to heal uneventfully (Fig. 4b). Seven patients had both syndesmotic screws and seven had only one screw (proximal of the two) inserted. Syndesmotic screw insertion was deemed unnecessary by the operating surgeon (contrary to the recommendations in surgical manual) in one patient. Insertion of the syndesmotic screws through the jig was unsuccessful in two cases. Syndesmotic screws were successfully inserted using free hand technique in both these cases. Seven (Fifty percent) patients started weight bearing in the immediate post-operative period (less than 2 weeks) in a below knee cast. The rest between 4–6 weeks post operatively. There was no subsequent loss of reduction of fracture from what was achieved intraoperatively. The fractures united in all cases. Fracture was considered “healed” when bony trabeculae crossed across the fracture site, in both anteroposterior and lateral views. Treatments in twelve patients were uneventful and were discharged in less than 5 months. One patient with open wound on
Fig. 4. Intraoperative image showing fracture of shaft of fibula at the tip of Fibula Rod (a) and x-ray showing healed ankle fracture (b).
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
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the medial side needed regular and prolonged wound care. Two patients needed removal of medial side metal ware (for prominence) and syndesmotic screws (due to its proximity to ankle joint) at 3 and 9 months. One patient developed pressure sore from plaster cast. There were no superficial or deep infections. At the time of postal survey two out of fifteen patients in the study had died due to unrelated causes. We had ten completed responses (postal questionnaires) from the remainder. The Foot and Ankle Ability Measure (FAAM) outcome score which is expressed as a percentage ranged from 25% to 100% (Interquartile range of 62–99%). The mean and median score was 78% and 91% respectively. The patient with suboptimal intraoperative reduction went on to develop arthritis and a low FAAM outcome score (25%). 4. Discussion Management of ankle fractures in the elderly can be a challenge because of poor skin condition, osteoporosis, poor compliance with postoperative weight bearing regime and medical comorbidities. “Close contact casting technique” performed by trained surgeons under anesthesia had a failure rate of 19% due to loss of reduction in a prospective trial [2]. Result from operative intervention for ankle fractures in the elderly has been shown to be satisfactory in more than 89% [3] and is associated with lower mortality rates than that in the non-operative group [4]. Failure of non-operative treatment coupled with better morbidity and mortality rates in the operative intervention group seem to tilt the balance in favor of operative treatment of these “tricky” injuries in these vulnerable elderly patients. The question that remains however is, which fixation device is better? Various operative techniques and implants (screws, headless compression screws, Rush rods, Knowles pins, plates including contoured Locked Compression Plates, unlocked and locked intramedullary devices) have been described and used in the past. Biomechanical studies have shown that intramedullary fixation with a load-sharing device provides a higher load to failure than traditional plate fixation in osteoporotic bone [6]. A cadaveric study comparing Fibula Rod against distal fibular locking plate showed similar failure characteristics in both the devices. This cadaveric study however showed inferior external rotation stiffness while maintaining the syndesmotic diastasis in the nail group and hence recommended using the nail with postoperative restrictions [7]. We report the clinical results of use of this locked intramedullary device, Fibula Rod System (Acumed). Our use of this implant has been very selective and this is reflected in the number of cases (n = 15), mean age (74 years) and age range (61–90 years) of patients in the study. Our study numbers per year are on par with the largest study on Fibula Rod (Acumed) published in literature [8]. This study from the designers of the implant itself described 105 cases over eight years in general population (22–95 years). To our knowledge this is the only published study from a hospital independent from the designers of this implant and selectively used in the elderly population. This implant has been used sparingly in special circumstances like severe swelling, open wounds, when the surgeon preferred the smaller incisions with intra-medullary device to a much larger incision for open plating procedures. This device also has an additional benefit of ability to perform a “closed” reduction of fibula fracture. The surgical technique describes steps to reduce the fracture when using this device. This maneuver was successful in all the cases. None of the fibula fractures in the study needed “open reduction”. With a 100% union rate in our study population, we achieved our primary objective of bone healing in these unstable ankle fractures with this device. Our results are comparable to the only
3
other study using fibula nailing (Biomet SST nail) in the elderly population [9] and with the results from the Fibula Rod implant designer hospital study [8]. One of the aims of internal fixation of intra-articular fractures is to mobilize patients early. In the elderly, compliance with weight bearing regimes can be a challenge. Whilst our postoperative weight bearing regime was mainly dependent on the intraoperative assessment of fracture fixation. It was also influenced by both mental and physical ability of the elderly patients to adhere to post-operative instructions. In our study, half of the patients started weight bearing in a below knee cast in the early postoperative period (less than two weeks) and this resulted in no subsequent loss of reduction or talus shift. Post-operative wound necrosis after primary closure of open ankle fractures can be as high as 16% [10]. In our study, nailing was performed primarily in all the open ankle fractures (n = 4). Wounds sustained were following low energy injuries and were on the medial aspect of ankle. The mechanism of injury and location of the wounds in our study concurred with the findings of a study in a level 1 trauma center [11]. There were no cases of superficial or deep seated infections. Delayed wound healing in one patient was related to an open wound on the medial side of ankle that was left to heal by secondary intention. One patient developed plaster cast pressure sore and we believe, this is unrelated to the implant. None of the ankle fracture fixations required revision for any reason. Two patients needed removal of distal syndesmotic screw as it was perceived to be too close to the ankle joint. When the tip of the Fibula Rod was within 5 mm of the tip of lateral malleoli, the distal syndesmotic screw was within 5 mm of the ankle joint in 5/ 7 cases. Conversely when the tip of Fibula Rod was buried by more than 5 mm only 2 out of 7 was within 5 mm of tibial plafond. We recommend the tip of the fibula rod be buried by at least 5 mm when contemplating the use of distal syndesmotic screw or use only the proximal of the two syndesmotic screws. In five (30%) cases the syndesmotic screws were angulated by >5 to tibial plafond distally. A combination of angulation and close proximity of the distal syndesmotic screw to plafond placed it too close to the ankle joint (Fig. 5a & b) and increasing the need for revision surgery. Orientation of these screws however was not detrimental to the healing of fractures. In 7 out of 15 patients only one syndesmotic screw was used. Syndesmosis was stable and the fractures united. Hence, we believe only one syndesmotic screw may be sufficient. It should ideally be placed and directed away from the plafond when using this implant.
Fig. 5. AP (a) and lateral view (b) of ankle showing close proximity of distal syndesmotic screw to ankle joint.
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
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Recent published reports comparing intramedullary versus extramedullary fixation of lateral malleolus fractures found intramedullary nail fixation either comparable [12], provide better functional results [13] or outperform [14] extramedullary fixation. All patients in our study, had satisfactory to good clinical outcomes at the time of discharge. At the time of postal assessment, with a mean follow up of 12 months (range 8–25 months), the mean Foot and Ankle Ability Measure (FAAM) score was 78.4% (Range 25–100, Interquartile range 62–99). The median FAAM outcome score was 91%. Considering the age of the study population, we believe the scores reinforced our assessment of a satisfactory to good outcome in such difficult fractures. 5. Limitations We acknowledge that our study was a retrospective study with a small sample size and multiple variables. Although our study shows promising results, a larger prospective randomized study is needed to come to statistically significant conclusions. This device in our institute was used when the surgeon deemed open plating procedures was riskier. Hence, we did not compare this device to modern locked plates nor performed cost benefit analysis. We do not propose this as an alternate to traditional fixation devices in routine cases but as a useful armamentarium at surgeon’s disposal when dealing with difficult cases. 6. Conclusion Fibula Rod System is a reliable operation for the fixation of lateral malleolus in ankle fractures. It offers good stability and achieves a good union rate. The associated complications are minor in nature. It is a viable option in the treatment of ankle fractures in the elderly. Ethical committee approval was not needed as this study was an internal review of results following the introduction of this system at our hospital. Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Conflict of interest statement The authors of this paper have no conflicts of interest to declare in the preparation and submission of this manuscript.
References [1] Kannus P, Palvanen M, Niemi S, Parkkari J, Jarvinen M. Increasing number and incidence of low-trauma ankle fractures in elderly people: Finnish statistics during 1970–2000 and projections for the future. Bone 2002;31:430–3. [2] Keene DJ, Mistry D, Nam J, Tutton E, Handley R, Morgan L, et al. The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years. Health Technol Assess 2016;20(October (75)):1–158. [3] Gauthé R, Desseaux A, Rony L, Tarissi N, Dujardin F. Ankle fractures in the elderly: treatment and results in 477 patients. Orthop Traumatol Surg Res 2016;102(June (4) Suppl)S241–4, doi:http://dx.doi.org/10.1016/j.otsr.2016.03. 001 Epub 2016 Mar 28. [4] Bariteau JT, Hsu RY, Mor V, Lee Y, DiGiovanni CW, Hayda R. Operative versus nonoperative treatment of geriatric ankle fractures: a medicare part A claims database analysis. Foot Ankle Int. 2015;36(June (6))648–55, doi:http://dx.doi. org/10.1177/1071100715573707 Epub 2015 Feb 24. [5] Acumed Fibula Rod System surgical technique. http://www.acumed.net/ resources/documents/fibula-rod-system-brochure-surgical-technique. (Last accessed 21 January 2017). [6] Smith G, Wallace R, Findlater G, White T. The fibular nail: a biomechanical study. Proceedings of the seventh SICOT/SIROT annual international conference. Unpublished results. [7] Switaj PJ, Fuchs D, Alshouli M, Patwardhan AG, Voronov LI, Muriuki M, et al. A biomechanical comparison study of a modern fibular nail and distal fibular locking plate in AO/OTA 44C2 ankle fractures. J Orthop Surg Res 2016;11 (September (1)):100, doi:http://dx.doi.org/10.1186/s13018-016-0435-5. [8] Bugler KE, Watson CD, Hardie AR, Appleton P, McQueen MM, Court-Brown CM, et al. The treatment of unstable fractures of the ankle using the Acumed fibular nail development of a technique. J Bone Joint Surg Br 2012;94(August (8)):1107–12, doi:http://dx.doi.org/10.1302/0301-620X.94B8.28620. [9] Rajeev A, Senevirathna S, Radha S, Kashayap NS. Functional outcomes after fibula locking nail for fragility fractures of the ankle. J Foot Ankle Surg 2011;50 (September–October (5))547–50, doi:http://dx.doi.org/10.1053/j.jfas.2011.04. 017 Epub 2011 Jun 1. [10] Ovaska MT, Madanat R, Mäkinen TJ. Predictors of postoperative wound necrosis following primary wound closure of open ankle fractures. Foot Ankle Int. 2016;37(April (4))401–6, doi:http://dx.doi.org/10.1177/ 1071100715609182 Epub 2016 Feb 1. [11] Ovaska MT, Madanat R, Honkamaa M, Mäkinen TJ. Contemporary demographics and complications of patients treated for open ankle fractures. Injury 2015;46(August (8))1650–5, doi:http://dx.doi.org/10.1016/j.injury.2015.04.015 Epub 2015 Apr 17. [12] Jain S, Haughton BA, Brew C. Intramedullary fixation of distal fibular fractures: a systematic review of clinical and functional outcomes. J Orthop Traumatol 2014;15(December (4))245–54, doi:http://dx.doi.org/10.1007/s10195-0140320-0 Epub 2014 Oct 11. [13] Asloum Y, Bedin B, Roger T, Charissoux JL, Arnaud JP, Mabit C. Internal fixation of the fibula in ankle fractures: a prospective, randomized and comparative study: plating versus nailing. Orthop Traumatol Surg Res 2014;100(June (4 Suppl.))S255–9, doi:http://dx.doi.org/10.1016/j.otsr.2014.03.005 Epub 2014 Apr 4. [14] Rehman H, McMillan T, Rehman S, Clement A, Finlayson D. Intrmedullary versus extramedullary fixation of lateral malleolus fractures. Int J Surg 2015;22 (October)54–61, doi:http://dx.doi.org/10.1016/j.ijsu.2015.07.697 Epub 2015 Aug 5.
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
Foot and Ankle Surgery xxx (2017) xxx–xxx
Contents lists available at ScienceDirect
Foot and Ankle Surgery journal homepage: www.elsevier.com/locate/fas
Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly Sudhakar Rao Challagundla* , Sandeep Shewale, Calum Cree, Amanda Hawkins Department of Trauma & Orthopaedics, Dumfries and Galloway Royal Infirmary, Bankend Road, Dumfries DG1 4AP, United Kingdom
A R T I C L E I N F O
A B S T R A C T
Article history: Received 1 February 2017 Received in revised form 11 April 2017 Accepted 19 April 2017 Available online xxx
Background: Operative management of ever increasing ankle fractures in the elderly need a reliable system of internal fixation. We present results of one such fixation, Fibula Rod System. Methods: Patients who underwent Fibula Rod System were included. Fracture union rate, complications, time to weight bearing and patient satisfaction using FAAM score were studied. Results: The mean age of the fifteen patients included was 74 years. Satisfactory reduction was achieved and maintained in all. All fractures united. There were no infections. Complications included lack of purchase of distal AP screw (n = 1), fracture of fibula shaft (n = 1), failure to insert syndesmotic screws through zig (n = 2), delayed secondary wound healing (n = 1) and removal of metal ware (n = 2). At a mean follow-up of 12 months (n = 10 responses), median FAAM score was 91% (Interquartile range of 62%–99%). Conclusion: Fibula Rod System providing good stability and union, is a reliable operation for ankle fractures in the elderly. © 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Keywords: Fibula Rod system Ankle fracture Fibula intramedullary nail
1. Introduction Ankle fractures in the elderly population is not an uncommon injury and the incidence is on the rise [1]. Skin condition, osteoporosis, poor compliance with postoperative weight bearing regime and comorbidities renders management of these injuries complicated. Non-operative management has a substantial risk of loss of reduction [2]. Operative management has been shown to produce satisfactory results [3] and reduce mortality rates [4]. In this age group with poor skin condition, open procedures are fraught with problems including delayed wound healing and infection. Intramedullary fixation of lateral malleoli was conceptualized to address some of these issues. We present the results of fixation of lateral malleolus in ankle fractures using one such intramedullary device, Fibula Rod System (Acumed) [5].
system (PACS) were reviewed. The decision to operate and use Fibula Rod for lateral malleolus fixation was at the discretion of the treating surgeon. Internal fixation of medial and posterior malleoli was performed as deemed necessary by the operating surgeon. The operated ankle was immobilized in a below knee back slab in the immediate post-operative period and changed to a below knee cast when the swelling permitted. Post-operative regime of weight bearing in the below knee cast was based on surgeon’s intraoperative assessment of the stability of the fixation. Patients were followed up at 2 weeks and 6 weeks. Patients were discharged to physiotherapists at 6 weeks in uncomplicated cases and at the earliest safe opportunity in cases requiring further clinical supervision. Fracture healing rate, time to weight bearing and intraoperative and postoperative complications were studied. Patient’s satisfaction was assessed using Foot and Ankle Ability Measure (FAAM) outcome score through a postal questionnaire.
2. Materials and methods 3. Results All ankle fracture fixations where the Fibula Rod System (Acumed) (Fig. 1) was used to stabilize lateral malleoli in the last two years were included in this retrospective observational study. Case notes including accident and emergency notes, operation notes and radiographs on picture archiving and communication
* Corresponding author. E-mail address: [email protected] (S.R. Challagundla).
In total fifteen ankle fractures were treated with the Fibula Rod System for lateral malleoli stabilization during the study period. Of these majority (n = 12) were low energy injuries. There were four open and eleven closed injuries. The wounds in all the open injuries were on the medial side (Fig. 2). Five patients needed manipulation by ambulance crew or in Accident and Emergency for subluxation or dislocation. There were ten patients with supination external rotation (stage 4) injuries, three with
http://dx.doi.org/10.1016/j.fas.2017.04.015 1268-7731/© 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
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Fig. 1. AP and lateral views of ankle fracture treated with Fibula Rod System. Fig. 3. Unstable bimalleolar ankle fracture (a) treated with Fibula Rod alone (b).
Fig. 2. Open fracture with wound on the anteromedial aspect of ankle joint with tibia protruding through the wound.
pronation external rotation and one case each of pronation abduction and supination adduction. The mean age of the study population was 74 years (range 61–90). Most (n = 12) were in female patients and eight of injuries were on the right. Fracture fixation using the Fibula Rod System was done primarily. One patient who presented with community acquired pneumonia and open ankle fracture dislocation, died in ICU on the 3rd post-operative day and was included only for radiological analysis and not for clinical follow up. The operations were performed by 4 different surgeons under general (n = 12, 80%) or spinal anesthesia (n = 3, 20%). The American Society of Anesthesiologists (ASA) grade of these patients was grade 3 (mode). Along with Fibula Rod fixation of lateral malleoli fracture, patients also underwent fixation of medial malleolus with screws (n = 10), buttress plate (n = 1) and tension band wiring (n = 2). One patient underwent antero–posterior screw fixation for posterior malleolar fragment. In two patients, the condition of the skin over the medial side of ankle prevented fixation of medial malleolus fracture. The surgeon was satisfied with the reduction of medial malleolus and the stability of the ankle following the insertion of Fibula Rod. Hence the medial side was left alone (Fig. 3a & b). The average tourniquet time (at 300 mmHg pressure) was 84 min (range 45–120 min). All patients received preoperative antibiotic prophylaxis and post-operative antibiotics (in open injuries) as per local protocol. Satisfactory reduction was achieved in all the cases using the technique described in the surgical technique manual for this
implant (Acumed). Intraoperative reduction was deemed satisfactory when the fibular length, alignment and ankle mortice (concentric joint space) was restored. The reduction in one patient was suboptimal with talus shift, when analyzed retrospectively. One patient had no distal antero-posterior screws inserted through the nail due to lack of purchase of the screws in the bone. One patient had fracture of fibula shaft at the tip of the Fibula Rod (Fig. 4a). Fracture occurred in the diaphyseal segment of fibula. In this patient, the ankle fracture and fibular shaft fracture went on to heal uneventfully (Fig. 4b). Seven patients had both syndesmotic screws and seven had only one screw (proximal of the two) inserted. Syndesmotic screw insertion was deemed unnecessary by the operating surgeon (contrary to the recommendations in surgical manual) in one patient. Insertion of the syndesmotic screws through the jig was unsuccessful in two cases. Syndesmotic screws were successfully inserted using free hand technique in both these cases. Seven (Fifty percent) patients started weight bearing in the immediate post-operative period (less than 2 weeks) in a below knee cast. The rest between 4–6 weeks post operatively. There was no subsequent loss of reduction of fracture from what was achieved intraoperatively. The fractures united in all cases. Fracture was considered “healed” when bony trabeculae crossed across the fracture site, in both anteroposterior and lateral views. Treatments in twelve patients were uneventful and were discharged in less than 5 months. One patient with open wound on
Fig. 4. Intraoperative image showing fracture of shaft of fibula at the tip of Fibula Rod (a) and x-ray showing healed ankle fracture (b).
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
G Model FAS 1052 No. of Pages 4
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the medial side needed regular and prolonged wound care. Two patients needed removal of medial side metal ware (for prominence) and syndesmotic screws (due to its proximity to ankle joint) at 3 and 9 months. One patient developed pressure sore from plaster cast. There were no superficial or deep infections. At the time of postal survey two out of fifteen patients in the study had died due to unrelated causes. We had ten completed responses (postal questionnaires) from the remainder. The Foot and Ankle Ability Measure (FAAM) outcome score which is expressed as a percentage ranged from 25% to 100% (Interquartile range of 62–99%). The mean and median score was 78% and 91% respectively. The patient with suboptimal intraoperative reduction went on to develop arthritis and a low FAAM outcome score (25%). 4. Discussion Management of ankle fractures in the elderly can be a challenge because of poor skin condition, osteoporosis, poor compliance with postoperative weight bearing regime and medical comorbidities. “Close contact casting technique” performed by trained surgeons under anesthesia had a failure rate of 19% due to loss of reduction in a prospective trial [2]. Result from operative intervention for ankle fractures in the elderly has been shown to be satisfactory in more than 89% [3] and is associated with lower mortality rates than that in the non-operative group [4]. Failure of non-operative treatment coupled with better morbidity and mortality rates in the operative intervention group seem to tilt the balance in favor of operative treatment of these “tricky” injuries in these vulnerable elderly patients. The question that remains however is, which fixation device is better? Various operative techniques and implants (screws, headless compression screws, Rush rods, Knowles pins, plates including contoured Locked Compression Plates, unlocked and locked intramedullary devices) have been described and used in the past. Biomechanical studies have shown that intramedullary fixation with a load-sharing device provides a higher load to failure than traditional plate fixation in osteoporotic bone [6]. A cadaveric study comparing Fibula Rod against distal fibular locking plate showed similar failure characteristics in both the devices. This cadaveric study however showed inferior external rotation stiffness while maintaining the syndesmotic diastasis in the nail group and hence recommended using the nail with postoperative restrictions [7]. We report the clinical results of use of this locked intramedullary device, Fibula Rod System (Acumed). Our use of this implant has been very selective and this is reflected in the number of cases (n = 15), mean age (74 years) and age range (61–90 years) of patients in the study. Our study numbers per year are on par with the largest study on Fibula Rod (Acumed) published in literature [8]. This study from the designers of the implant itself described 105 cases over eight years in general population (22–95 years). To our knowledge this is the only published study from a hospital independent from the designers of this implant and selectively used in the elderly population. This implant has been used sparingly in special circumstances like severe swelling, open wounds, when the surgeon preferred the smaller incisions with intra-medullary device to a much larger incision for open plating procedures. This device also has an additional benefit of ability to perform a “closed” reduction of fibula fracture. The surgical technique describes steps to reduce the fracture when using this device. This maneuver was successful in all the cases. None of the fibula fractures in the study needed “open reduction”. With a 100% union rate in our study population, we achieved our primary objective of bone healing in these unstable ankle fractures with this device. Our results are comparable to the only
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other study using fibula nailing (Biomet SST nail) in the elderly population [9] and with the results from the Fibula Rod implant designer hospital study [8]. One of the aims of internal fixation of intra-articular fractures is to mobilize patients early. In the elderly, compliance with weight bearing regimes can be a challenge. Whilst our postoperative weight bearing regime was mainly dependent on the intraoperative assessment of fracture fixation. It was also influenced by both mental and physical ability of the elderly patients to adhere to post-operative instructions. In our study, half of the patients started weight bearing in a below knee cast in the early postoperative period (less than two weeks) and this resulted in no subsequent loss of reduction or talus shift. Post-operative wound necrosis after primary closure of open ankle fractures can be as high as 16% [10]. In our study, nailing was performed primarily in all the open ankle fractures (n = 4). Wounds sustained were following low energy injuries and were on the medial aspect of ankle. The mechanism of injury and location of the wounds in our study concurred with the findings of a study in a level 1 trauma center [11]. There were no cases of superficial or deep seated infections. Delayed wound healing in one patient was related to an open wound on the medial side of ankle that was left to heal by secondary intention. One patient developed plaster cast pressure sore and we believe, this is unrelated to the implant. None of the ankle fracture fixations required revision for any reason. Two patients needed removal of distal syndesmotic screw as it was perceived to be too close to the ankle joint. When the tip of the Fibula Rod was within 5 mm of the tip of lateral malleoli, the distal syndesmotic screw was within 5 mm of the ankle joint in 5/ 7 cases. Conversely when the tip of Fibula Rod was buried by more than 5 mm only 2 out of 7 was within 5 mm of tibial plafond. We recommend the tip of the fibula rod be buried by at least 5 mm when contemplating the use of distal syndesmotic screw or use only the proximal of the two syndesmotic screws. In five (30%) cases the syndesmotic screws were angulated by >5 to tibial plafond distally. A combination of angulation and close proximity of the distal syndesmotic screw to plafond placed it too close to the ankle joint (Fig. 5a & b) and increasing the need for revision surgery. Orientation of these screws however was not detrimental to the healing of fractures. In 7 out of 15 patients only one syndesmotic screw was used. Syndesmosis was stable and the fractures united. Hence, we believe only one syndesmotic screw may be sufficient. It should ideally be placed and directed away from the plafond when using this implant.
Fig. 5. AP (a) and lateral view (b) of ankle showing close proximity of distal syndesmotic screw to ankle joint.
Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015
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S.R. Challagundla et al. / Foot and Ankle Surgery xxx (2017) xxx–xxx
Recent published reports comparing intramedullary versus extramedullary fixation of lateral malleolus fractures found intramedullary nail fixation either comparable [12], provide better functional results [13] or outperform [14] extramedullary fixation. All patients in our study, had satisfactory to good clinical outcomes at the time of discharge. At the time of postal assessment, with a mean follow up of 12 months (range 8–25 months), the mean Foot and Ankle Ability Measure (FAAM) score was 78.4% (Range 25–100, Interquartile range 62–99). The median FAAM outcome score was 91%. Considering the age of the study population, we believe the scores reinforced our assessment of a satisfactory to good outcome in such difficult fractures. 5. Limitations We acknowledge that our study was a retrospective study with a small sample size and multiple variables. Although our study shows promising results, a larger prospective randomized study is needed to come to statistically significant conclusions. This device in our institute was used when the surgeon deemed open plating procedures was riskier. Hence, we did not compare this device to modern locked plates nor performed cost benefit analysis. We do not propose this as an alternate to traditional fixation devices in routine cases but as a useful armamentarium at surgeon’s disposal when dealing with difficult cases. 6. Conclusion Fibula Rod System is a reliable operation for the fixation of lateral malleolus in ankle fractures. It offers good stability and achieves a good union rate. The associated complications are minor in nature. It is a viable option in the treatment of ankle fractures in the elderly. Ethical committee approval was not needed as this study was an internal review of results following the introduction of this system at our hospital. Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Conflict of interest statement The authors of this paper have no conflicts of interest to declare in the preparation and submission of this manuscript.
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Please cite this article in press as: S.R. Challagundla, et al., Intramedullary fixation of lateral malleolus using Fibula Rod System in ankle fractures in the elderly, Foot Ankle Surg (2017), http://dx.doi.org/10.1016/j.fas.2017.04.015