We compared a new fixation system, the Targon Femoral Neck (TFN) hip screw, with the current standard treatment of cannulated screw fixation. This was a single-centre, participant-blinded, randomised controlled trial. Patients aged 65 years and over with either a displaced or undisplaced intracapsular fracture of the hip were eligible. The primary outcome was the risk of revision surgery within one year of fixation.

A total of 174 participants were included in the trial. The absolute reduction in risk of revision was of 4.7% (95% CI 14.2 to 22.5) in favour of the TFN hip screw (chi-squared test, p = 0.741), which was less than the pre-specified level of minimum clinically important difference. There were no significant differences in any of the secondary outcome measures.

We found no evidence of a clinical difference in the risk of revision surgery between the TFN hip screw and cannulated screw fixation for patients with an intracapsular fracture of the hip.

Cite this article: Bone Joint J 2014;96-B:652–7.

Background. The Targon FN plate is a combination of the sliding hip screw and multiple cancellous screws. It is used in the fixation of intracapsular fractures of the neck of femur. The aim of this prospective audit was to assess clinical and radiological outcomes of Targon FN. Method. All patients who had a Targon FN fixation over a period of 18 months at a district general hospital were included. A pro forma was completed using medical records, including x-ray images. Results. Thirty-five patients were identified. Median (IQR) age was 73 (57–82). Median (IQR) waiting time for surgery was 27 hours (17–51). Median (IQR) operating time was 58 (50–65) minutes. The patients were followed up at 6, 12 18 and 24 months. Three cases of avascular necrosis were reported and two cases of non-union. Seven cases were found where the Targon FN was not used correctly. No cases of implant failure were reported where the Targon FN was used according to manufacture guidelines. Five revision surgeries took place or were being planned for cases of avascular necrosis, non union and symptomatic hardware. One case was identified which would have been better treated with a hemiarthroplasty than Targon FN. Conclusion. We recommend that the Targon FN plate continue to be used in our department. The success rate of the implant could be improved by educational workshops in our department to ensure that all surgeons adhere strictly to the operating technique described by the manufacturer. We recommend continuing careful selection of patients for Targon FN and to continue a follow up to 24 months

Purpose: We report preliminary results after treatment of humeral fracturs with a Targon centromedullary nail (Aesculap(r)). Material and methods: Forty-five patients, predominantly women, underwent surgery from June 2001 to June 2002. Mean age was 63.5 years. The right side predominated. The series included 28 proximal fractures (65.9 years): 3-4 fragments (n=14), two fragments (n=8), pathological fracture (n=3),metaphyseo-diaphyseal fracture (n=3); and 17 shaft fractures (59.5 years): pathological fractures (n=4), nonunion (n=3), trauma (n=10). The Beach position, fractured limb free, was used with a superolateral approach. We inserted 28 Targon PH nails, including nine long nails, for proximal fractures and 17 Targon H nails for shaft fractures. Nail diameter was 8 mm. Nails were locked with four self-locking proximal screws (5 mm) and two distal screws (3.5 mm). The patients were immobilised with an arm to body brace. Hanging limb exercises were initiated immediately and active exercises at bone healing. The Constant score and radiographic measures were recorded at last follow-up. Results: Mean follow-up was 12.2 months. We had six deaths and five patients lost to follow-up. Bone healing was achieved at eight weeks on average. Fracture reduction was acceptable for 37 limbs, including three which required open reduction. There were nine postoperative complications: superficial infection (n=1), distal screw pull out (n= 3), distal screw fracture (n=1), nail fracture (n=1). The mean Constant score was 69 (30–96). Discussion: Proximal fractures of the humerus are often comminuted displaced fractures requiring cephalic arthroplasty. Total functional recovery is often difficult leading to mid and long-term problems for this young population. Stable quadruple proximal locking, associated with good filling of the canal by the nail enables fracture stablisation and satisfactory maintenance of the tuberosities. This stable assembly allows early rehabilitation. These advantages are particularly important for shaft fractures in young patients. The material does however have certain limitations related to fragility of the distal screws which are situated near the circumflex bundle for the Targon PH nail. Conclusion: Our early results are encouraging for humeral fractures, both in elderly and young patients. This type of osteosynthesis can be a useful alternative to arthroplasty and allows early rehabilitation necessary for good functional recovery

Objective: Osteoporotic fractures of the distal forearm are demanding in terms of operative therapy and implants used. Volar fixed angle plating has become a standard procedure for these fractures. Recently intra-medullary nailing was introduced in clinical practice for the use in distal radial fractures. This randomized multi-center study compares both fixation techniques in terms of clinical and radiological outcome as well as quality of life score. Material and Methods: Up to now a total of 85 patients with extra- and intraarticular unstable fractures of the distal radius were included. 53 patients (Targon DR®, B. Braun-Aesculap: n=24; 2.4 mm plate, Synthes: n=29) completed the 6 months follow-up. Follow up examinations included an osteodensitometry using pQCT, X-ray analysis and a detailed clinical function examination. In addition the SF36 questionaire for quality of life assessment was carried out. Results: The operation time for volar plating was significantly longer than for intramedullary nailing (50.3±20.2 min versus 40.2±13.4 min), as was the time in hospital (5.4±1.8 days versus 2.2±0.6 days) (MW±SD; p< 0.05; Student-t-Test, post hoc: Bonferonni). The Gartland an Werley function score averaged 2.7±1.1 versus 1.9±0.8 for volar plating in comparision to treatment with the Targon DR® nail and thus just failed to reach statistical significance (p = 0.052). Radiological Evaluation revealed bony healing in all patients of both groups. Radial length was maintained in all but one patient (96%) in the nailing group and all but 2 patients (93%) in the plating group. A loss of volar tilt −5°was seen in 1 patient in the nailing group (4%) and 3 patients in the plating group (10%). Of interest radiological signs of bony healing developed much faster after intramedullary nailing. The Quality of life as measured by the SF36 was minimaly diminished in both groups (body/social function: Targon DR®: 56.3±25.1/63.4±21.2 points − 2.4 mm plate: 52.8±23.3/60.5±23.3 points). Osteoporotic bone loss was detected in a total of 72% of patients. Osteoporosis had no adverse effects on bony healing or functional parameters. We encountered two complications. One mild CRPS (volar plating) and in one case paraesthesia of the R. superficialis n. radialis (intramedullary nailing). Conclusion: Both intramedullary nailing with the Targon DR® nail and volar plating using a 2.4 mm volar fixed angle plate allows stable fixation of osteoporotic distal forearm fractures. Lower operation time and minimally invasive operative procedure of intramedullary nailing is accompanied by faster mobilization

Background: The purpose of this study was to compare the stability of the 2.4 mm palmar locking compression plate (LCP) and a new intramedullary nail-plate-hybrid Targon DR (TDR) for dorsally comminuted distal radius fractures. Methods: An extraarticular 10 mm dorsally open wedge osteotomy was created in 8 pairs of fresh frozen distal radii to simulate an AO-A3-fracture. The fractures were stabilized with one of the fixation constructs. The specimens were loaded axially with 200 N and dorsal-excentically with 150 N. Cyclic loading with 2000 cycles as well as loading to failure were performed under axial loading. Results: Axial loading revealed that intramedullary osteosynthesis (Targon DR: 369N/mm) was significantly (p=0.017) stiffer than plate osteosynthesis (LCP: 131 N/mm). With 214 N/mm the intramedullary nail was also more stable during dorsal excentric loading than the LCP with 51 N/mm (p=0.012). After the 2000 cycles of axial loading with 150 N the Targon group was still significant stiffer than the LCP group under both loading patterns. Neither group showed a significant change in stiffness after the 2000 cycles. The Targon DR group even showed a slight increase with 435,22 N/mm (p = 0.161), while the LCP group showed a slight decrease with 122.24 N/mm (p = 0.575) during axial loading. Under dorsal excentric loading the Targon group was still significant stiffer with 212.46 N/mm than the LCP group with 44.96 N/mm (p=0.012). The load to failure tests demonstrated again the superiority of intramedullary nailing (625N) when compared to plate osteosynthesis (403N) (p< 0.025). Conclusions: The study shows that both implants are able to withstand physiological loads occuring under unloaded wrist motion. Neither implant showed a significant loss of stability after 2000 cycles long-term loading. Intramedullary nailing with the Targon DR of a distal A3 radial fracture is biomechanically more stable than volar fixed angle plating with the 2.4 mm LCP under axial and dorsal-excentric loads in our experimental setup

A total of 56 male patients with a displaced intracapsular fracture of the hip and a mean age of 81 years (62 to 94), were randomised to be treated with either a cemented hemiarthroplasty (the Exeter Trauma Stem) or reduction and internal fixation using the Targon Femoral Plate. All surviving patients were reviewed one year after the injury, at which time restoration of function and pain in the hip was assessed. There was no statistically significant difference in mortality between the two groups (7/26; 26.9% for hemiarthroplasty vs 10/30; 33.3% for internal fixation). No patient treated with a hemiarthroplasty required further surgery, but eight patients treated by internal fixation did (p = 0.005), five requiring hemiarthroplasty and three requiring total hip arthroplasty. Those treated by internal fixation had significantly more pain (p = 0.02). The restoration of mobility and independence were similar in the two groups. These results indicate that cemented hemiarthroplasty gives better results than internal fixation in elderly men with a displaced intracapsular fracture of the hip. Cite this article: Bone Joint J 2015;97-B:992–6

In a randomised trial involving 598 patients with 600 trochanteric fractures of the hip, the fractures were treated with either a sliding hip screw (n = 300) or a Targon PF intramedullary nail (n = 300). The mean age of the patients was 82 years (26 to 104). All surviving patients were reviewed at one year with functional outcome assessed by a research nurse blinded to the treatment used. The intramedullary nail was found to have a slightly increased mean operative time (46 minutes (. sd. 12.3) versus 49 minutes (. sd. 12.7), p < 0.001) and an increased mean radiological screening time (0.3 minutes (. sd. 0.2) versus 0.5 minutes (. sd. 0.3), p <  0.001). Operative difficulties were more common with the intramedullary nail. There was no statistically significant difference between implants for wound healing complications (p = 1), or need for post-operative blood transfusion (p = 1), and medical complications were similarly distributed in both groups. There was a tendency to fewer revisions of fixation or conversion to an arthroplasty in the nail group, although the difference was not statistically significant (nine versus three cases, p = 0.14). The extent of shortening, loss of hip flexion, mortality and degree of residual pain were similar in both groups. The recovery of mobility was superior for those treated with the intramedullary nails (p = 0.01 at one year from injury). In summary, both implants produced comparable results but there was a tendency to better return of mobility for those treated with the intramedullary nail

Purpose of the study: To compare the DHS plate fixation with the Targon PF nail for the treatment of intratro-chanteric fractures. Material and methods: This was a prospective randomized study including 60 patients hospitalized in the emergency setting between December 2003 and June 2004for intratrochanteric fractures. The AO classification was used. We analyzed: patient status (ASA), operative time (type of implant, duration), the postoperative period (blood loss, radiologic findings, duration of hospital stay, early postoperative complications) and at last follow-up, Harris hip score, date of resumed walking, mortality. Patients were assessed at three months postop. This study included 60 patients, 34 with a Targon PF nail and 26 with a DHS. Mean patient age for nailing was 81 years (SD 12.8, range 23–86); for DHS it was 82 years (SD 9.8; range 47–97). Results: Mean blood loss was 410 ml with the Targon PF nail and 325 ml with the DHS, a nearly significant difference (p=0.07). The other results did not demonstrate any significant difference. At three months five cases of screw cut out were noted. Bone healing was achieved in all cases. The Trargon PF nail and the DHS provide equivalent results, with less bleeding an lesser cost for the DHS

Background: Reverse obliquity and transverse fractures of the proximal femur represent a distinct fracture pattern in which the mechanical forces displace the femur medially thus increasing the risk of fixation failure. There is a paucity of published literature in this area of trauma. This study constitutes the largest series of such fractures. Methods: Using the hip fracture registry at this institution 101 reverse obliquity and transverse fracture patterns were identified from 3336 consecutive hip fractures. All surviving patients were followed up for 1 year. Results: Of 100 patients treated operatively, 59 were treated with 1350 sliding hip screws (SHS), 22 were treated with 1350 sliding hip screw devices designed to resist medialization (3 sliding hip screws with trochanteric plate and 19 Medoff plates), and 19 were treated with intramedullary sliding hip screw devices (1 short Gamma nail, 9 long Gamma nails, 6 Reconstruction nails, 6 long Targon nails, 1 short Targon nail). The SHS had 4 failures (6.8%), and the intramedullary devices one failure (5.3%). Those extramedullary devices augmented to prevent medialization had higher failure rates (1 of 3 SHS with trochanteric plate and 3 of 19 Medoff plates), with combined failure rate of 15.8%. Conclusion: The 1350 SHS and the intramedullary devices had similar failure rates of 6.8% and 5.2% respectively. Those extramedullary devices designed to prevent medialization had higher failure rates (combined failure rate of 4/22 or 18%). This is similar to the high failure rate in 950 devices reported elsewhere. This suggests that extramedullary devices attempting to combat the difficult biomechanics of these fractures are unsuccessful. Better results can be obtained by using the standard 1350 SHS or with intramedullary sliding hip screw devices

In Displaced Intracapsular Hip Fractures (ICHF) in young active patients, preservation of the femoral head and its blood supply are of high importance and urgent surgical treatment with anatomic reduction and internal fixation is the preferred intervention. Due to the strong varus displacement shear forces exerted across the hip, there are relatively high complication rates after fixation. There is no consensus regarding the optimal fixation device or technique. This retrospective study compared closed reduction internal fixation method using cannulated cancellous screw (CCS) with the Targon Femoral Neck (TFN) hip fixed angle screw. Data regarding, gender, operational data, duration of surgery, complications, NAS (Numerical Analogue Scale) pain score, Modified Harris Hip Score (MHHS) and SF-12 scores were retrieved for patients younger than 65 with displaced ICHF. Eighty-two patients were included in the study, 30 patients treated with CCS were compared to 52 patients treated with TFN. Fracture configuration (Garden and Pauwel classifications), mean time to surgery and complication rate did not differ significantly. Operative time did differ significantly between groups (CCS 56 minutes, TFN 92 minutes, p<0.001). At final follow-up the CCS group reported less pain (NAS 2.3 vs 3.5, p< 0.049) and better Mental Health Composite score of SF-12 (p=0.017) compared to the TFN group. Complication rates for the treatment of displaced ICHF with TFN and CCS showed no significant differences; however, the functional outcomes, as presented by the NAS and Mental Health Composite score of SF-12, showed superiority for CCS treatment. As this fixation method is related to reduce costs, we suggest CCS for the treatment of displaced ICHF in the young population

Fractures of the proximal femur at the level of the lesser trochanter (reversed and transverse fracture lines, Evans classification type II, AO classification A3 fractures) are known to have an increased risk of fixation failure. 58 patients with such a fracture were randomised to have the fracture fixed with either an intramedullary nail (220 mm Targon PF nail) or a sliding hip screw (SHS). The mean age of the patients was 82 and 11% were male. All patients were followed up for one year by a research nurse blinded to the treatment groups. Mean length of surgery was 50 minutes for the nail versus 52 minutes for the SHS. There were no differences between groups in the need for blood transfusion. Operative complications tended to be less for the nail group (1/27 versus 5/26). Mean hospital stay was 18 days for the nail group versus 29 days for those treated with the SHS. The only fracture healing complications were one case of cut-out in the SHS group and two cut-outs in the nail group, two of which required revision surgery. During follow-up those patients treated with the nail reported a tendency to lower pain scores than those treated with the SHS (p=0.04 at two months). This difference persisted even at one year from injury. Mortality and regain of mobility was similar between groups. These results indicate that for these difficult fractures types both types of fixation produce comparable outcomes

Fractures of the proximal femur at the level of the lesser trochanter (reversed and transverse fracture lines, Evans classification type II, AO classification 31. A3 fractures) are known to have an increased risk of fixation failure. 53 patients with such a fracture were randomised to have the fracture fixed with either an intramedullary nail (220 mm Targon Proximal Femoral nail) or a Sliding Hip Screw (SHS). The mean age of the patients was 82 and 11% were male. All patients were followed up for one year by a research nurse blinded to the treatment groups. Mean length of surgery was 51 minutes for the nail versus 53 minutes for the SHS. There were no differences between groups in the need for blood transfusion. Operative complications tended to be less for the nail group (1/27 versus 5/26). Mean hospital stay was 17 days for the nail group versus 29 days for those treated with the SHS (p< 0.0001). The only fracture healing complications were one case of cut-out in each group requiring revision surgery. During follow-up those patient treated with the nail reported significantly lower pain scores than those treated with the SHS (p=0.08). This difference persisted even at one year from injury. In addition there was a tendency to a better regain of mobility in the first nine months from injury for those treated with the nail. These results indicate that for these difficult fractures types an intramedullary nails produces superior results to the Sliding Hip Screw

400 patients with a trochanteric hip fracture were randomised to fixation with either a 220mm long Targon PF (proximal femoral) nail or a Sliding Hip Screw. All surgery was undertaken or supervised by one surgeon. All patients were followed up for a minimum of one year by a blinded observer. The mean age was 82 years (range 27 to 104 years), 20% were male. Mean length of surgery was slightly increased for the nail (44 versus 49 minutes, p=0.002). Fluoroscopic screening time was increased in the nail group (0.3 versus 0.6 minutes, p< 0.0001). Intra-operative complications were more common with the nailing. There was no difference in blood transfusion requirement between groups. Postoperatively there was no difference in the occurrence of medical complications or mortality. Deep wound infection requiring removal of the implant occurred in one case in the SHS group. In addition there were two cases of cut-out, three of plate detachment from the femur and one non-union in the SHS group, requiring secondary surgery. There were only once compilations in the nailed a case of cut-out which required secondary surgery. At follow-up there was no difference in pain scores between groups but there was a tendency to improved mobility in the nailed group (p=0.004). These results suggest that with improved designs and surgical technique, the newer versions of short nails for proximal femoral fractures may not suffer from the complications of the earlier short intramedullary nails. Intramedullary fixation can result in a lower re-operation rate (3.5% versus 0.5%) and improved mobility in comparison to the sliding hip screw

The Targon Femoral Neck Hip Screw has been designed to improve the fixation of intracapsular hip fractures. The new implant consists of a small plate with six locking screw ports. The two distal holes are used to fix the plate to the lateral cortex of the femur. Three of four 6.5mm cancellous screws are passes through the proximal holes and across the fracture site. The proximal screws are dynamic to allow for collapse of the fracture across the femoral neck. A jig is used to aid insertion of the device with minimal surgical exposure of the femur. For the first 91 patients treated with this implant, the mean age of the patients was 75 years (range 46–103). The mean length of surgery was 45 minutes. The median length of hospital stay till discharge home was 8 days). For the 43 undisplaced fractures there has been one case of non-union and one case of avascular necrosis. For the 48 displaced fractures (Garden III and IV) there have been five cases of fracture non-union and one case of plate detachment from the femur treated by repeat fixation. In addition there was one deep wound sepsis treated by removal of the implant and girdlestone arthroplasty. Observation of those fractures that have healed shows there has been between 4 to 18mm of collapse at the fracture site which occurs along the line of the femoral neck. There has been no tilting of the fracture into varus as occurs with a parallel screw method. The results to date show an incidence of fracture non-union that is about a third that which is to be expected with a parallel screw method. This new implant may be a significant advance in the treatment of this difficult and common fracture

Distal radius fractures are typical and frequent fracture of elderly woman with reduced bone density. Thus implant fixation is more difficult. Dorsal and radial comminution are frequent in these patients and so reduction and angle stable osteosynthesis needed. The angle stable plate, often also multidirectional is today the most common stabilisation device. Because of the introduction of bulky and bended implants as the Micronail or Targon DR wich require difficult opening of the bone with awles we decided to test the XS radius nail witch is a 4,5mm or 3,5mm straight nail and witch is introduced after guide wire placement and over drilling with a canulated drill of the same diameter. It is locked parallel to the joint in 3 different directions with angular stability with threaded wires. Methods 16 radius sawbones were osteotomised corresponding to a A3 Fracture and stabilised with a angle stable plate (8) and XS nail (8). 1000 alternating load cycles from 20–200N were performed and the deformation was registered. Also a FE analysis with the MSC Patran/Marc softwere were performed. Also the calculated deformation in the FE study was 20% lower. Also deformation amplitude was lower with 0.31mm compared to 0.42mm in the plate group. The differences however were not significant. Both devices show good biomechanical results. The XS nail has the advantage of mainly intraosseus position, simple operation technique with introduction over a guide wire from the proc. Styloideus radii and over drilling with a canulated drill of the same size. The exposure of the N rad. superf. must be performed. First clinical evaluation is presented. Due to the results we developed a anatomically adapted XS radius nail. The results of the first 100 patients are presented. Conclusions. Both angular stable plate and XSR nail can be used in unstable distal radius fracture fixation. The mainly intraosseus position of the nail and saving of the pronator quadratus as well as lower deformation are in favour of the XSR nail. However frontal plane fractures and very comminuted fractures are better treated with a multidirectional locking plate due to technical reasones so that we use the XSR nail mainly in A3 and C1 fractures

The Sliding Hip Screw (SHS) is currently the treatment of choice for all trochanteric hip fractures. An alternative treatment is the short femoral nail. Earlier designs of these nails were associated with an increased fracture healing complication rate in comparison to the sliding hip screw. The new designs of nails (third generation nails) may however be as good as or even superior to sliding hip screw fixation. We conducted a large randomised trial to compare the Targon Proximal Femoral Nail with the Sliding Hip Screw. Patients with trochanteric hip fractures as per the AO classification (A1–A3) were randomised to either implant. All surgery was supervised by one surgeon. All patients were followed up for a minimum of one year months by a blinded observer. The mean age was 82 years, range 27 to 104 years), 20% were male. Length of surgery was slightly increased for the nail (44 versus 49 minutes, p=0.002). Fluoroscopic screening time was increased in the nail group (0.3 versus 0.6 minutes, p< 0.0001). Intra-operative complications were more common with the nailing. There was no difference in blood transfusion requirement between groups. Postoperatively there was no difference in the occurrence of medical complications or mortality. Deep wound infection requiring removal of the implant occurred in one case in the SHS group. In addition there were two cases of cut-out, three of plate detachment from the femur and one non-union in the SHS group, requiring secondary surgery. There was only one compilation in the nailed a case of cut-out which required secondary surgery. At follow-up no difference in pain scores but there was a tendency to improved mobility in the nailed group (p=0.004). These results suggest that with improved designs and surgical technique, the newer versions of short nails for proximal femoral fractures may not suffer from the complications of the earlier short intramedullary nails. Intramedullary fixation can result in a lower re-operation rate (3.5% versus 0.5%) and improved mobility in comparison to the sliding hip screw

The Targon Femoral Neck Hip Screw has been designed to improve the fixation of intracapsular hip fractures. Fracture healing complications after internal fixation occur in approximately 30–40% of displaced fractures and 5–10% of undisplaced fractures. The new implant consists of a small plate with six locking screw ports. The two distal holes are used to fix the plate to the lateral cortex of the femur. Three of four screws are passes through the proximal holes and across the fracture site. These 6.5mm screws are dynamic to allow for collapse of the fracture across the femoral neck. A jig is used to aid insertion of the device with minimal surgical exposure of the femur. For the first 200 patients treated with this implant at the first centre to use this implant, the mean age of the patients was 77 years (range 39–103), 58% were female. The mean length of surgery was 46 minutes and the mean length of anaesthesia 59 minutes. The median length of institutional stay till discharge home was 9 days (mean 13 days, range 3–107). Four telescoping screws were used in 55% of patients, three in 44% and two in 1% of patients. Follow-up of patients at present is a minimum of six months. For the 74 undisplaced fractures there has been one case of non-union and one case of avascular necrosis. For the 121 displaced fractures (Garden III and IV) there have been eleven cases of fracture non-union, six cases of avascular necrosis and two cases of plate detachment from the femur treated by repeat fixation. In addition there was one deep wound sepsis treated by removal of the implant and girdlestone arthroplasty. For the four basal fractures treated there has been one case of plate detachment from the femur. Observation of those fractures that have healed shows there has been between 0 to 22mm of collapse at the fracture site which occurs along the line of the femoral neck. There has been no tilting of the fracture into varus as occurs with a parallel screw method. The results to date show an incidence of fracture healing complications is about a third that which is to be expected with a parallel screw method. This new implant may be a significant advance in the treatment of this difficult and common fracture

Aims

To compare the outcomes for trochanteric fractures treated with a sliding hip screw (SHS) or a cephalomedullary nail.

Aims

A lack of supporting clinical studies have been published to determine the ideal length of intramedullary nail in fixation of trochanteric fractures of the hip. Nevertheless, there has been a trend to use shorter intramedullary nails for the internal fixation of trochanteric hip fractures. Our aim was to determine if the length of nail affected the outcome.