Intraoperative complications using the Bio-Transfix femoral fixation implant in anterior cruciate ligament reconstruction

Transcription

1 Arch Orthop Trauma Surg (2010) 130: DOI /s ARTHROSCOPY AND SPORTS MEDICINE Intraoperative complications using the Bio-Transfix femoral fixation implant in anterior cruciate ligament reconstruction Michail Kokkinakis Æ Alexander Ashmore Æ Magdi El-Guindi Received: 26 February 2009 / Published online: 29 September 2009 Ó Springer-Verlag 2009 Abstract The use of biodegradable Transfix femoral fixation technique is a safe and well-accepted method when performing anterior cruciate ligament reconstruction. We report on three cases of deformation and back out of the Bio-Transfix implant over the lateral, distal femoral cortex, with failure of the passing wire when advancing the graft into the femoral tunnel in one of these patients. Two of the patients presented with symptoms of iliotibial band friction syndrome, while the third patient was asymptomatic. The graft had clinically integrated demonstrating AP and rotational stability. The symptoms relieved after removal of the failed Bio-Transfix implants in the symptomatic patients. The aetiology of the implant failure and the alternative methods to avoid such complications are discussed. Keywords ACL reconstruction Bio-Transfix Nitinol wire Iliotibial band friction syndrome Complications Technical note Introduction The rehabilitation protocol following ACL reconstruction consists of immediate weight bearing and early motion [1]. Early rehabilitation demands rigid intraoperative mechanical fixation of the graft allowing aggressive physiotherapy M. Kokkinakis (&) A. Ashmore M. El-Guindi Stoke Mandeville Hospital, 43 Aston House, Mandeville Road, Aylesbury, Buckinghamshire HP21 8AL, UK mkokkinakis@doctors.org.uk to begin before biologic incorporation of the graft in the bone tunnels [2]. There are different options for femoral graft-fixation. These include interference screws, which provide the advantage of rigid fixation at the native ligament footprint adjacent to the articular surface [3] and cortical fixation using endobuttons with the potential risk of inferior graft stiffness due to greater graft length, windscreen-wipering (anterior/posterior) or bungee cord effect (superior/inferior) subject to graft tunnel motion [4]. The Transfix femoral fixation technique (Arthrex) provides secure fixation closer to the tunnel aperture than does that provided by cortical fixation. This technique allows engagement of the graft in the femoral tunnel after passing it over a guide wire with the graft lying perpendicular and over the Transfix device. The Transfix femoral fixation can be used as rigid or biodegradable device, with the latter providing no distortion on MRI and requiring no removal in cases of arthroplasty or revision. It has been demonstrated as a safe and successful technique in anterior cruciate ligament reconstruction [5] with similar clinical results to interference screws [6]. Despite its increasing popularity among surgeons, intraoperative complications have been reported using this technique [7 14]. We report on three cases with intraoperative failure of the graft passing wire when advancing the graft into the femoral tunnel in one patient and subsequent deformation and prominence of the Bio-transfix implant over the lateral, distal femoral cortex in all three patients. The implant was not broken in any of the cases. A review of the literature on complications after Transfix femoral fixation technique and the difference to other transfemoral devices including Rigidfix and bone mulch screw was carried out and technical tips on how to prevent these complications are recommended.

2 376 Arch Orthop Trauma Surg (2010) 130: The Bio-Transfix femoral fixation method We performed 18 ACL reconstructions in our constitution using the Bio-Transfix femoral fixation method from September 2006 to October 2008 (same surgeon). The ipsilateral hamstring tendons were used for grafting and a transtibial approach was performed in all cases. After passing the guide pin using the Arthrex femoral guide through the tunnel hook, a broach, with depth stop collar, was drilled over the guide pin to broach the cortex for the Bio-Transfix implant. The depth of the soft tissue was measured with the calibration on the drill shaft, which was critical point of secondary control of subsequent implant insertion depth. After the graft was advanced through the tibia tunnel into the femoral tunnel with the aid of the nitinol-graft passing wire, the Bio-Transfix implant was then impacted over the nitinol wire well into the femoral cortex until the impactor flange to contact the cortical bone surface. Depth markings on the impactor had to match the prior broach depth mark to secondarily, as mentioned above, confirm proper implant insertion depth. After impactor removal the final confirmation of implant depth was performed with finger palpation. An interference screw and sheath (Intrafix) was used to secure tibia fixation of the graft. Case reports All the three reported cases underwent ACL reconstruction using the above-mentioned Bio-Transfix femoral fixation method. The rehabilitation consisted of immediate full weight bearing and early full range of motion. No braces or continuous passive motion devices were used. The first case is of a 36-year-old male, who sustained rupture of the ACL following a football injury and underwent ACL reconstruction, using allograft, 15 years prior to presentation to our orthopaedic service. Recurrence of knee instability led to a diagnostic arthroscopy 1 year ago, which confirmed the failure of the allograft. A revision ACL reconstruction was performed 6 months ago using an autologous four-strand hamstring graft and the Bio-Transfix system. Intraoperatively the nitinol-graft passing wire was twisted while advancing the graft through the tibia and femoral tunnel. It was not possible to remove the twisted wire and therefore it was left in situ (Fig. 1). We passed the Bio-Transfix implant through the lateral end of the wire and then through the graft loop and buried the pin-head well into the lateral femoral cortex. Eight weeks post the ACL revision-procedure the patient started complaining of pain to the operated knee joint. Clinical examination revealed swelling, pain and grinding to the lateral aspect of the operated knee. An MRI scan at that Fig. 1 Twisted wire left in situ post-revision ACL reconstruction. Implants of the initial ACL reconstruction using allograft are also shown time revealed the pin-translation laterally with effusion on the pin-entry point (Fig. 2). The clinical and radiological diagnoses of iliotibial band irritation were evident. The ACL graft was both clinically and radiologically intact. The bioabsorbable Transfix pin was removed a month later. The patient was entirely asymptomatic at 6 and 12 weeks orthopaedic follow up post-implant removal, implying this had been the cause of the mechanical irritation of the iliotibial band. The second case is a 35-year-old female, who presented with clinical symptoms of an iliotibial band friction syndrome 2 months following primary ACL reconstruction using the Bio-Transfix system. MRI imaging of the operated knee confirmed backing out of the Bio-Transfix implant as the source of the friction while the ACL graft was intact (Fig. 3). Subsequent removal of the implant had relieved his symptoms at 6- and 12-week followup. Fig. 2 Bio-Transfix device head lateral protrusion causing iliotibial band friction and localised effusion

3 Arch Orthop Trauma Surg (2010) 130: Fig. 3 Localised oedema on the lateral aspect of distal femur caused by friction between Bio-Transfix device and iliotibial band The third case is of 35-year-old male who presented with knee instability following a sporting injury. Clinical examination and MRI imaging demonstrated ACL rupture and ACL reconstruction was performed using the Bio- Transfix implant. Three months post-surgery the patient developed moderate symptoms of iliotibial band friction syndrome. An MRI scan revealed the same picture of lateral protrusion of the Bio-Transfix device. After continuation of the intensive physiotherapy the symptoms had improved 6 months following surgery and the removal of the implant was not undertaken. No stress X-rays or specific biomechanical tests were carried out to confirm the stability of the ACL graft after the Bio-Transfix pin removal as the patients were asymptomatic with no clinical signs of knee instability. It is important to emphasize that in all the three cases there was intraoperative confirmation of the correct implant depth using the depth markings on the impactor as well as the good coverage of the pin-head into the femoral cortex with finger palpation. Discussion The transfemoral fixation technique to fix 4-strand hamstring autografts is gaining popularity among orthopaedic surgeons. It provides secure fixation that is closer to the tunnel aperture than does that provided by cortical fixation [4]. Bioabsorbable cross pins (Rigidfix) [15], the bone mulch screw [16] and the Transfix implants [5] have all been successfully used for transfemoral fixation of ACL grafts. Transfix implants and the bone mulch screw are considered as toggle fixation where the tendon is looped around a part of the implant to suspend the graft within the bone tunnel allowing tensioning of the individual strands and resulting in increased graft strength and stiffness [17]. The Rigidfix femoral cross pins are considered as semitoggle fixation since it is not possible to wrap the loops of the tendons around the cross pins and the fixation relies on the pins crossing the tightly sutured tendon loop bundle in the femoral tunnel. It is controversial, which is the optimal method for transfemoral fixation of the ACL graft. In two randomised controlled clinical trials, Harilainen et al. [18] and Harilainen and Sandelin [19] found no statistical or clinical relevant difference between Rigidfix-crosspins and interference metal or bioscrews. In a randomised experimental study, Kousa et al. [20] showed that the bone mulch screw was stronger than the Rigidfix implants in the single-cycle load-to-failure test and had lower residual displacement after cyclic loading. The high ultimate failure load as well as the high stiffness of the bone mulch screw was also confirmed in another study by To et al. [21]. Milano et al. [22] demonstrated superiority of the Transfix implants after comparison to other devices including Rigidfix after performing a biomechanical study and showing both bioabsorbable and titanium Transfix to offer better and more predictable results in terms of elongation, fixation strength and stiffness. Wu et al. [23] compared different biodegradable femoral fixation devices and found the Bio- Transfix to provide the least graft displacement under cyclic loading but the Rigidfix to have better stability and stiffness. The greater total graft slippage of the Rigidfix when compared to the Bio-Transfix has been confirmed with other laboratory studies [24, 25]. Another biomechanical study of femoral fixation implants revealed higher yield load values for the Bio-Transfix and similar stiffness to bioabsorbable femoral cross pins [26]. The Transfix femoral fixation technique can be performed by either using a titanium or a biodegradable pin. There is only one biomechanical study comparing femoral fixation devices including the two Transfix implants and has shown no difference in graft elongation, failure load and stiffness [22]. The Bio-Transfix femoral fixation device is made of poly-l-lactic acid (PLLA). The degradation rate of PLLA is influenced by the percentage of crystallinity, molecular weight, surface area open to degradation, and porous or non-porous device formats. PLLA is highly crystalline and slowly degrading. Degradation can last up to several years and is incomplete [27]. The main advantages of Bio-Transfix when compared to the titanium Transfix are undistorted MRI imaging and uncompromised revision surgery, while the disadvantages are invisibility of these implants in X-ray imaging and possible tissue reactions. PLLA has been shown not to evoke inflammatory reactions to the bone [28]. Various complications have been documented with the transfemoral fixation techniques for ACL grafts. Tunnel widening after using metal femoral cross pins [29], lateral pin slip [24] and breakage of bioabsorbable cross pins [30]

4 378 Arch Orthop Trauma Surg (2010) 130: with subsequent intraarticular loose bodies [31] have all been reported. The blow out of the posterior femoral cortex by improper pin placement and subsequent absence of sufficient medial bony buttress for the implant has been suggested as the cause of breakage of cross pins [30, 32]. In our cases the MRI images excluded a posterior femoral cortex perforation or breakage of the Bio-Transfix implants. Complications regarding the Transfix implants have also been documented. Pelfort et al. [7] reported the presence of iliotibial band friction syndrome in two cases using the Bio-Transfix femoral fixation device. The implants had extruded laterally and the implant-tail was broken in both cases. Our patients presented with similar symptoms but the Bio-Transfix device was only laterally slipped and not broken and the cause of iliotibial band irritation was the prominent lateral pin-end. Protrusion of the Bio-Transfix implant has also been reported in the medial retinacular area causing clinical symptoms after mal positioning of the biodegradable pin [11]. Slip of the implant can also occur with the titanium Transfix devices, causing iliotibial band friction syndrome. Clark et al. [12] performed a prospective study in 22 patients using rigid Transfix implant and identified 2 patients with lateral protrusion of the implant: removal of the implant in one case was needed to eliminate the irritation of the iliotibial band. In a retrospective clinical study of 49 patients where the Bio-Transfix implant was used, Cossey et al. [10] reported five broken pins and three deformed implants with no clinical symptoms and all individuals to have returned to pre-injury sporting activities at an average MRI follow up of 14 weeks. Choi et al. [9] reported twisting of the graft passing wire while advancing the graft through the tibial and femoral tunnels. They suggested direct vision of the graftadvancement through the anteromedial portal to prevent twisting of the wire. Lee et al. [8] reported eight cases of broken nitinol wire in more than 150 patients operated using the Transfix device. They suggested vertical traction of the graft with an extra wire along an extended femoral tunnel to the lateral cortex from a thigh portal. Through that portal the correct placement of the graft, an eventual twisting of the wire and the appropriate insertion of the Transfix device could be observed and controlled directly with the arthroscope. In our first case, the twisted wire could not be removed and was left in situ compromising the correct placement of the Bio-Transfix device and the graft integration. Concerns have also been reported with regards to iatrogenic injuries to the medial and posterolateral neurovascular structures. Pujol et al. [13] showed that there is specific iatrogenic risk of transverse femoral fixation using the anteromedial portal approach and emphasized the use of the transtibial technique as the gold standard. Finally, stress fractures of the medial femoral supracondylar area after using the Bio-Transfix devices were reported in two professional athletes (one soccer and one basketball player), and it was hypothesized that the accelerated rehabilitation program used might have represented a risk factor for stress fractures when associated with the guide pin exit hole in the medial femoral cortex [14]. In our cases, the MRI images illustrated slight deformation of the Bio-Transfix femoral fixation device in the part surrounded by the graft and in addition showed lateral slippage of the device. The patients symptoms started 2 3 months post-surgery; too early for degradation to be the mode of failure. Early and aggressive mobilisation could have caused increased loading of the device exceeding its ultimate strength and resulting in mechanical failure with deformation and protrusion or even slip of the femoral pin. Last but not at least, we should emphasize that these complications could well be contributed to the learning curve needed for this technically demanding technique when considering the small number of patients operated. Technical tips Twisting of the graft-passing wire, lateral slip and breakage of the Bio-Transfix implant are recognised complications in anterior cruciate ligament reconstruction. The contributing factors may be technical error due to the necessary learning curve, biomechanical reasons or early heavy loading of the graft. Smooth, gradual advance of the wire with maintained traction force to the wire ends (with or without vertical traction) and direct graft observation are some useful technical tips to prevent these complications. No back or forth motions should be performed while advancing the graft. Forceful pulling of the wire can increase the risk of wire twisting with subsequent laceration of the graft and failure to insert the graft fully into the femoral socket. If the graft is not advancing smoothly then the surgeon should suspect twisting of the wire and thus the graft should be pulled back out and re-advanced with a new wire. During the Bio-Transfix pin insertion, traction on the free wire-ends should be maintained to prevent twisting of the wire. Proper positioning of the femoral pins decreases the risk of iatrogenic injuries to the neurovascular structures. Light impacting of the pin, confirmation of the appropriate depth markings on the impactor, good exposure with a longer skin incision and digital palpation of the pin entry point are all necessary steps to provide adequate pin insertion.

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