Talar body fractures are high energy intraarticular injuries that are best management by anatomical reduction and secure fixation to improve outcomes. The talus is relatively inaccessible surgically and requires extensive soft tissue dissection and/or osteotomies to gain adequate open visualisation. There are a small number of case reports on arthroscopic assisted fixation in the literature. This case series reports on the technique and early outcomes of six patients all of whom presented with significant intraarticular displacement and who were managed entirely arthroscopically. The fractures were of the main body of the talus involving the ankle and subtalar joints and all had preoperative CT scans. All six patients underwent posterior ankle and subtalar arthroscopy with cannulated screws used to stabilise the fractures after reduction. Visualisation of the fracture reduction was excellent. After 10 days in a backslab, the patients were protected in a boot and encouraged to actively move their ankles. Weight bearing was permitted once union appeared complete. There were no early complications of infection, avascular necrosis or VTE. There was one patient that had a non-clinically significant migration of a screw. Two patients were lost to follow up early due to being visitors. The mean length of follow up was 12 months in the remainder. The remaining four patients all returned to their preoperative level of activity. All had demonstrable subtalar stiffness. There was no early post-traumatic arthritis. This series represents the largest so far published. The main flaw in this report is the lack of long term follow up. While this report cannot state superiority over open techniques it is a safe, effective and acceptable technique that has significant conceptual benefits

Introduction. Ankle fractures represent approximately 10% of the fracture workload and are projected to increase due to ageing population. We present our 5 years outcome review post-surgical management of ankle fractures in a large UK Trauma unit. Methods. A total of 111 consecutive patients treated for an unstable ankle fracture were entered into a database and prospectively followed up. Baseline patient characteristics, complications, further intervention including additional surgery, functional status were recorded during five-year follow-up. Pre-injury and post-fixation functional outcome measures at 2-years were assessed using Olerud-Molander Ankle Scores (OMAS) and Lower Extremity Functional Scales (LEFS). A p value < 0.05 was considered significant. Results. The mean age was 46 with a male:female ratio of 1:1.1. The distribution of comorbidities was BMI >30 (25%), diabetes (5%), alcohol consumption >20U/week (15%) and smoking (26%). Higher BMI was predictive of worse post-op LEFS score (p = 0.02). Between pre-injury and post fixation functional scores at 2 years, there was a mean reduction of 26.8 (OMAS) and 20.5(LEFS). Using very strict radiological criteria, 31 (28%) had less than anatomical reduction of fracture fragments intra-operatively. This was, however, not predictive of patients' functional outcome in this cohort. Within 5-year period, 22 (20%) patients had removal of metalwork from their ankle, with majority 13 (59%) requiring syndesmotic screw removal. Further interventions included: joint injection (3), deltoid reconstruction (1), arthroscopic debridement (1), superficial sinus excision (2), and conversion to hindfoot nail due to failure of fixation (1). Reduction in OMAS was predictive of patients' ongoing symptoms (p=0.01). Conclusion. There is a significant reduction in functional outcome after ankle fracture fixation and patients should be counselled appropriately. Need for removal of metalwork is higher in patients who require syndesmosis stabilisation with screw(s)

Background. Anatomical reduction of unstable Lisfranc injuries is crucial. Evidence as to the best methods of surgical stabilization remains sparse, with small patient numbers a particular issue. Dorsal bridge plating offers rigid stability and joint preservation. The primary aim of this study was to assess the medium-term functional outcomes for patients treated with this technique at our centre. Additionally, we review for risk factors that influence outcomes. Methods. 85 patients who underwent open reduction and dorsal bridge plate fixation of unstable Lisfranc injuries between January 2014 and January 2019 were identified. Metalwork was not routinely removed. A retrospective review of case notes was conducted. The Manchester-Oxford Foot Questionnaire summary index (MOXFQ-Index) was the primary outcome measure, collected at final follow-up, with a minimum follow-up of 24 months. The American Orthopedic Foot and Ankle Society (AOFAS) midfoot scale, complications, and all-cause re-operation rates were secondary outcome measures. Univariate and multivariate analyses were used to identify risk factors associated with poorer outcomes. Results. Mean follow-up 40.8 months (24–72). Mean MOXFQ-Index 27.0 (SD 7.1). Mean AOFAS score 72.6 (SD 11.6). 48/85 patients had injury patterns that included an intra-articular fracture and this was associated with poorer outcomes, with worse MOXFQ and AOFAS scores (both p < 0.001). 18 patients (21%) required the removal of metalwork for either prominence or stiffness. Female patients were more likely to require metalwork removal (OR 3.89, 95% CI 1.27 to 12.0, p = 0.02). Eight patients (9%) required secondary arthrodesis. Conclusions. This is the largest series of Lisfranc injuries treated with dorsal bridge plate fixation reported to date and the only to routinely retain metalwork. The technique is safe and effective. The presence of an intraarticular fracture is a poor prognostic indicator. Metalwork removal is more likely to be needed in female patients but routine removal may not be essential

Introduction. Hindfoot intramedullary nail fixation (HFN) or fibula pro-tibial screw fixation (PTS) are surgical options for ankle fractures in patients with multiple co-morbidities; we compared their outcomes. Methods. A retrospective review of 135 patients who underwent HFN fixation (87 patients) or PTS fixation (48 patients) for ankle fractures (AO/OTA A/B/C) from 5 major trauma centres. Patient demographic data, co-morbidities, Charlson Co-morbidity Index Score (CCIS), weight-bearing, and post-operative complications were recorded. Radiographs were assessed for non-union and anatomical reduction. Results. HFN estimated 10-year survival was 27±31% and was 48±37% for PTS (p<0.001). Average time to full weightbearing (FWB) in the HFN group was 1.7±3.3 weeks compared to 7.8±3.8 weeks in the PTS group (p<0.001). Despite this, HFN fixation carried a greater VTE risk (p=0.02). HFN accompanied by joint preparation had greater risk of infection (p=0.01), metalwork failure (p=0.02) and wound breakdown (p=0.01). The overall complication rate in diabetic patients was 56%, but 76% in HFN patients. In the HFN group 17 (20%) patients died at 1 year. Patients with open fractures(p=0.01), dementia (p<0.05), and a higher CCIS (p=0.04) were more likely to die after HFN surgery. Age and co-morbidity matched data showed a higher rate of complications and mortality in those above 75 years fixed with a HFN, irrespective of CCIS. In those between 60–75 years, there was a greater risk of superficial infection and mortality after HFN, irrespective of CCIS. These complications were not seen after PTS. Conclusion. HFN carries a greater risk of superficial infections, VTE and mortality compared to PTS, independent of age and CCIS. Diabetes leads to a greater comparative risk of deep infections, wound breakdown and non-union in HFN. Alternative methods of fixation (e.g. PTS) should be considered before HFN. HFN may be suitable in selective indications where other methods are not appropriate

Aim. Anatomical reduction and Stable fixation of Lisfranc injuries is considered the gold standard. There is controversy about how it is best achieved. Some surgeons would advocate routine open anatomical reduction, which as a concept was popular in 1980s but the same anatomical reduction and fixation can be achieved percutaneously. We describe our method of close reduction and percutaneous fixation and present our results. Materials and methods. 22 patients with a minimum follow up of 12 months were included. We achieved satisfactory anatomical reduction percutaneously in all patients and internal fixation was performed using cannulated screws for medial and middle columns. Functional outcome was evaluated using Foot and Ankle Disability Index (FADI) and components of this score were analysed individually to assess which domain was most affected. Vertical ground reaction forces were measured using a force plate in a walking platform. Results. The average age at operation was 48 years (17–67). Mean follow up was 20 months (13–60). The average Foot & Ankle Disability Index at final follow up was 79 (66–94). No loss of reduction or metal breakage was noted. Walking on uneven surface, going down stairs, heavy work and pain first thing in the morning were the domains of functional Index that showed poor recovery. None of the patients had pain at rest. Only three patients found it extremely hard to return to recreational activities. None of the patients had problems related to wound. Gait analysis showed a prolonged push-off (p=0.22) and significantly prolonged pre-swing phase (p=0.015) of the affected limb. Conclusions. Percutaneous reduction and fixation technique for Lisfranc injuries provides predicatable good functional outcome and gait pattern similar to open tecchinques with a potentially decreased risk of wound problems

Introduction. Post-traumatic arthritis is the commonest cause of arthritis of the ankle. Development of arthritis is dependent on the restoration of pre-injury anatomy. To assess the effect of grade of lead surgeon on the accuracy of surgical reduction, we performed a retrospective radiographic analysis of all ankle fractures undergoing open reduction and internal fixation, in a single institution. Method. All patients treated by surgical intervention in an 11 month period (January to November 2011) were included, with the grade of lead surgeon performing the operation recorded.105 patients, 48 males and 53 females, were included with a mean age of 41 years (range: 17–89). Standard antero-posterior (AP) and mortise views were analysed for tibiofibular overlap, ankle clear space and talocrural angle and compared to standardised values from the literature. Lead surgeon grade was stratified as either, trauma consultant, senior registrar (years 4+) or junior registrar (years 1–3). Results. Radiographic reduction within accepted margins was achieved in 78% of ankles on the AP radiograph and 81% on the mortise view. Trauma consultants achieved the highest rate of anatomical reduction, followed by senior registrars, with junior registrars achieving the lowest rate; the rates of anatomical reduction on the mortise view were 83.3%, 79.2% and 75%, respectively. However, senior registrars performed the majority of cases (70%). Conclusion. Radiographic reduction in this institute is comparable to that in the literature. The majority of cases are performed by senior trainees who are able to restore to anatomical reduction radiographically. Junior registrars achieved the lowest rate of anatomical reduction, which may reflect their level of experience and a greater need for supervision in the early years of specialty training

Aims. The aim of this retrospective study was to compare the functional and radiological outcomes of bridge plating, screw fixation, and a combination of both methods for the treatment of Lisfranc fracture dislocations. Patients and Methods. A total of 108 patients were treated for a Lisfranc fracture dislocation over a period of nine years. Of these, 38 underwent transarticular screw fixation, 45 dorsal bridge plating, and 25 a combination technique. Injuries were assessed preoperatively according to the Myerson classification system. The outcome measures included the American Orthopaedic Foot and Ankle Society (AOFAS) score, the validated Manchester Oxford Foot Questionnaire (MOXFQ) functional tool, and the radiological Wilppula classification of anatomical reduction. Results. Significantly better functional outcomes were seen in the bridge plate group. These patients had a mean AOFAS score of 82.5 points, compared with 71.0 for the screw group and 63.3 for the combination group (p < 0.001). Similarly, the mean Manchester Oxford Foot Questionnaire score was 25.6 points in the bridge plate group, 38.1 in the screw group, and 45.5 in the combination group (p < 0.001). Functional outcome was dependent on the quality of reduction (p < 0.001). A trend was noted which indicated that plate fixation is associated with a better anatomical reduction (p = 0.06). Myerson types A and C2 significantly predicted a poorer functional outcome, suggesting that total incongruity in either a homolateral or divergent pattern leads to worse outcomes. The greater the number of columns fixed the worse the outcome (p < 0.001). Conclusion. Patients treated with dorsal bridge plating have better functional and radiological outcomes than those treated with transarticular screws or a combination technique. Cite this article: Bone Joint J 2018;100-B:468–74

Aims. Arthroscopically controlled fracture reduction in combination with percutaneous screw fixation may be an alternative approach to open surgery to treat talar neck fractures. The purpose of this study was thus to present preliminary results on arthroscopically reduced talar neck fractures. Patients and Methods. A total of seven consecutive patients (four women and three men, mean age 39 years (19 to 61)) underwent attempted surgical treatment of a closed Hawkins type II talar neck fracture using arthroscopically assisted reduction and percutaneous screw fixation. Functional and radiological outcome were assessed using plain radiographs, as well as weight-bearing and non-weight-bearing CT scans as tolerated. Patient satisfaction and pain sensation were also recorded. Results. Primary reduction was obtained arthroscopically in all but one patient, for whom an interposed fracture fragment had to be removed through a small arthrotomy to permit anatomical reduction. The quality of arthroscopic reduction and restoration of the talar geometry was excellent in the remaining six patients. There were no signs of talar avascular necrosis or subtalar degeneration in any of the patients. In the whole series, the functional outcome was excellent in five patients but restricted ankle movement was observed in two patients. All patients had a reduction in subtalar movement. At final follow-up, all patients were satisfied and all but one patient were pain free. Conclusion. Arthroscopically assisted reduction and fixation of talar neck fractures was found to be a feasible treatment option and allowed early functional rehabilitation. Cite this article: Bone Joint J 2018;100-B:461–7

Aims. Involvement of the posterior malleolus in fractures of the ankle probably adversely affects the functional outcome and may be associated with the development of post-traumatic osteoarthritis. Anatomical reduction is a predictor of a successful outcome. The purpose of this study was to describe the technique and short-term outcome of patients with trimalleolar fractures, who were treated surgically using a posterolateral approach in our hospital between 2010 and 2014. Patients and Methods. The study involved 52 patients. Their mean age was 49 years (22 to 79). There were 41 (79%) AO 44B-type and 11 (21%) 44C-type fractures. The mean size of the posterior fragment was 27% (10% to 52%) of the tibiotalar joint surface. Results. Reduction was anatomical in all patients with a residual step in the articular surface of ≤ 1 mm. In nine of the C-type fractures (82%), the syndesmosis was stable after fixation of the posterior fragment and a syndesmosis screw was not required. Apart from one superficial wound infection, there were no wound healing problems. At a mean radiological follow-up of 34 weeks (seven to 131), one patient with a 44C-type fracture had widening of the syndesmosis which required further surgery. Conclusion. We conclude that the posterolateral surgical approach to the ankle gives adequate access to the posterior malleolus, allowing its anatomical reduction and stable fixation: it has few complications. Take home message: Fixation of the posterior malleolus in trimalleolar fractures can be easily done via the posterolateral approach whereby anatomical reduction and stable fixation can be reached due to adequate visualisation of the fracture. Cite this article: Bone Joint J 2016;98-B:812–17

Aims

The optimal management of posterior malleolar ankle fractures, a prevalent type of ankle trauma, is essential for improved prognosis. However, there remains a debate over the most effective surgical approach, particularly between screw and plate fixation methods. This study aims to investigate the differences in outcomes associated with these fixation techniques.

Lisfranc fracture dislocations of the midfoot are uncommon but serious injuries, associated with posttraumatic arthrosis, progressive deformity, and persistent pain. Management of the acute injury aims to restore anatomic tarsometatarsal alignment in order to minimise these complications. Reduction and stabilisation can be performed using image-guided percutaneous reduction and screw stabilisation (aiming to minimise the risk of wound infection) or through open plating techniques (in order to visualise anatomic reduction, and to avoid chondral damage from transarticular screws). This retrospective study compares percutaneous and open treatment in terms of radiographic reduction and incidence of early complications. Case records and postoperative radiographs of all patients undergoing reduction and stabilisation of unstable tarsometatarsal joint injuries between 2011 and 2014 in our institution were reviewed. Dorsoplantar, oblique and lateral radiographs were assessed for accuracy of reduction, with malreduction being defined as greater than 2mm tarsometatarsal malalignment in any view. The primary outcome measure was postoperative radiographic alignment. Secondary outcome measures included the incidence of infection and other intra- or early postoperative complications. During the study period, 32 unstable midfoot injuries were treated, of which 19 underwent percutaneous reduction and screw stabilisation and 13 underwent open reduction and internal fixation. Of the percutaneous group, no wound infections were reported, and there were four (21.1%) malreduced injuries. Of the open group, two infections (15.4%) were observed, and no cases of malreduction. In conclusion, our study shows a strong trend towards increased risk of malreduction when percutaneous techniques are used to treat midfoot injuries, and an increased risk of infection when open surgery is used. Whilst conclusions are limited by the retrospective data collection, this study demonstrates the relative risks to consider when selecting a surgical approach

Aims

The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes.

Aims

The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.

Background. Lisfranc/midfoot injuries are complex injuries with a reported incidence of 1 in 55000 in literature and frequently overlooked. But, recently they are becoming more commonly diagnosed with advent of CT scan and examination under anaesthesias (EUA) for suspicion fractures. Here we present a case series results of a single surgeons experience over the last 6 years. Methods. Retrospective review of 68 patients treated by a single surgeon over the last 6 years. Injuries were diagnosed on plain Xrays, clinic examination. Any suspicious injury were further assessed by a CT scan, all injuries were confirmed by EUA and treated with open reduction and internal fixation within 4 weeks of injury. Post-operative immobilisation in full cast for 6 weeks then a removal boot with non-weight bearing for a total of 3months. They were followed up regularly initially at 3, 6 and 12months. At final review the following data was collected: clinical examination, plain x-ray looking for: late deformity, signs of OA in Lisfranc joint, Auto fusion rate, rate of metal work failure. The x-rays findings were correlated with: (1) type of fixation. (2) The following scores: FAOS, AOFAS-M, specially designed new foot and ankle score. Results. 43 males: 25 females. 37 right: 31 left sided injuries. 90% were fully weight bearing with minimal discomfort after 6months. In 12 months all of them returned to their normal daily life activities. Wound complications: 2 of them had initial wound complications which were treated successfully with 2 weeks of oral antibiotics, 2 had lateral scar tenderness. One had loosened metal work, revised to fusion. Conclusion. Early operative intervention with good anatomical reduction can minimise the potential chronic disability associated with these injuries. This is a largest series of Lis-franc injuries of a single surgeon with good clinical outcome following surgical fixation

Persistent pain is a common cause of disability in patients after fractures of the calcaneum. Amongst the possible causes for post traumatic pain is the development of degenerative osteoarthritis of the posterior facet of the subtalar joint. However there are many other causes of post-traumatic hindfoot pain which require consideration prior to treatment. Knowledge of the patho-anatomy of calcaneal fractures is required to reach an accurate diagnosis. Significant symptoms and disability may be treated by arthrodesis of the subtalar joint. Post-traumatic arthritis in the non-operatively treated calcaneal fracture is however usually associated with deformity of the hindfoot, disordered hindfoot biomechanics, lateral wall fibular impingement and fibular tendon dysfunction. Fractures treated by primary open reduction and fixation should be well aligned but despite anatomic reduction may also develop posterior facet arthritis. Symptoms may also be caused by prominence or impingement of the implant, particularly of locked perimeter plates on the lateral wall. Patients therefore require careful assessment prior to surgery and any operative measures have to address these key features in order to produce a satisfactory clinical result. This lecture will address the potential problems of this type of surgery and key features in the clinical assessment and imaging of these patients. Subtalar arthrodesis in the presence of deformity is technically complex and requires careful planning in order to correct the deformity and to produce a well aligned hindfoot to allow corrected biomechanics without impingement and the fitment of suitable footwear. The surgical techniques and different types of surgery required to adequately manage the posterior facet and deformity will be covered and will include arthroscopically assisted in-situ fusion, the safe approaches for open surgery and techniques to reconstruct the lateral wall, fibular tendon function and osteotomies required to restore calcaneal height and alignment

Introduction. Syndesmosis injuries are significant injuries and require anatomical reduction. However, stabilisation of these injuries with syndesmosis screws carries specific complications and many surgeons advocate a second operation to remove the screw. Primary Tightrope suture fixation has been shown to be an effective treatment for syndesmotic injuries and avoids the need for a second operation. Materials and Methods. A retrospective audit identified patients who were treated for syndesmosis injuries over a two year period. Theatre and clinic costs were obtained to compare the cost of syndesmosis fixation using diastasis screws with the estimated cost of primary syndesmosis fixation using a Tightrope suture. Results. 79 patients received diastasis screw fixation of syndesmosis injuries between January 2007 and January 2009. The mean number of follow up clinic appointments was 3.7 following initial surgery, and 2.2 following diastasis screw removal. Allowing for device, theatre time and clinic appointment costs, and an estimated average of 4 follow up appointments following Tightrope syndesmosis fixation, primary fixation with this device could a saving of 34 theatre slots, 68 outpatient clinic appointments, and £12,138 per year at our hospital. Discussion. Biomechanical studies have demonstrated a reduction in normal tibiotalar external rotation with the presence of a diastasis screw, and there are several published reports of complications when these screws are retained. The Tightrope suture provides reduction of the syndesmosis whilst allowing normal physiological movement at the distal tibiofibular joint and negates the need for a second operation to remove the implant. In addition there may be improvements in foot and ankle scores and a faster return to work when these devices are used compared with traditional screw fixation. Conclusion. In addition to the patient benefits, our audit suggests that there may be significant financial benefits associated with primary syndesmosis fixation with Tightrope sutures

Diagnosis. a. History and exam. i. True Lisfranc fracture dislocations are NOT difficult to diagnose. b. Midfoot sprains or subtle injuries. i. These are DIFFICULT to diagnose. - subtle x-ray findings with minimal displacement. i) Exam: - be “suspicious” of midfoot sprains. - TMT tenderness, swelling. - inability to WB. ii) Mechanism of injury:. - indirect twisting injury (athletic). - crush injury of the foot (trauma). - axial forefoot loading (dancers, jumpers). iii) Investigations:. - X-rays usually normal or subtle widening. need to assess all 3 views in detail. standing AP compare to the other side. -Stress x-rays: - if clinical symptoms indicate - severe injury + pain but x-ray looks normal. - MRI useful for anatomic/instability correlation. - CT scan good for subtle injuries/fractures and displacement. - Bone scan positive in subacute/chronic pain situation. Treatment. a) Surgical Indications. i) Any displacement/positive stress xrays/test. ii) Surgical technique. - open reduction or closed and percutaneus fixation. - anatomic reduction essential. - NWB period up to 6 weeks. - WB with protection for another 4-6 weeks. iii. Screw vs tightrope fixation. iv. Hardware removal. b) Non-operative. i) Stable non-displaced sprain (need to make sure this is stable, ie stress views). - 6 to 8 weeks NWB. - expect prolonged recovery up to 6 months with. proper treatment. Controversial Issues:. a. Do all injuries with mild displacement have to be fixed operatively?. b. Arthrodesis vs fixation for soft tissue lisfranc with mild displacement?. c. Arthrodesis vs fixation subacute or chronic presentation?. d. Hardware removal?

Conventionally, medial malleolus fractures are treated surgically with anatomical reduction and internal fixation using screws. There seems to be no consensus, backed by scientific study on the optimal screw characteristics in the literature. We retrospectively examined case notes and radiographs of 48 consecutive patients taken from our trauma database (21 male, 27 female) with an average age of 50 years (range 16-85) who had undergone medial malleolus fracture fixation with screws at the Royal Free Hospital, London between January 2009 and June 2010. The most commonly used screw was the AO 4.0 mm diameter cancellous partially-threaded screw in 40, 45 and 50 mm lengths (40 mm n = 28, 45 mm n = 26, 50 mm n = 23) with the threads passing beyond the physeal scar in all cases. Incomplete reduction defined as > 1mm fracture displacement was observed on post-operative x-rays in 12 out of 48 cases (25%), all of which relied on partially-threaded screw fixation. In 5 cases where AO 4.0 mm diameter fully-threaded screws engaging the physeal scar had been used, no loss of reduction was observed. This unusual, occasional use of fully-threaded screws prompted us to investigate further using a porcine model and adapted pedo-barographic transducer. We compared pressures generated within the fracture site using AO 4.0 mm partially-threaded cannulated screws, 4.0 mm partially-threaded cancellous screws and 4.0 mm fully-threaded cancellous screws. Fully-threaded cancellous 4.0 mm diameter screws generated almost 3 times the compression of a partially-threaded cancellous screw with superior stability at the fracture. Partially-threaded screws quickly lost purchase, compression and stability particularly when they were cannulated. We also observed that screw thread purchase seemed enhanced in the physeal region. We conclude that fully-threaded cancellous 4.0 mm AO screws are superior to longer partially-threaded screws and that use of cannulated 4.0 mm partially-threaded screws should be avoided in fixation of medial malleolus fractures

Aims

The morphology of medial malleolar fracture is highly variable and difficult to characterize without 3D reconstruction. There is also no universally accepeted classification system. Thus, we aimed to characterize fracture patterns of the medial malleolus and propose a classification scheme based on 3D CT reconstruction.

Aims

In a randomized controlled trial with two-year follow-up, patients treated with suture button (SB) for acute syndesmotic injury had better outcomes than patients treated with syndesmotic screw (SS). The aim of this study was to compare clinical and radiological outcomes for these treatment groups after five years.