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SummaryThe Fracture Improvement with Teriparatide (Fix-IT) study randomized 13 women with an atypical femur fracture to immediate vs delayed teriparatide therapy; all were followed for 12 months. Results suggested a trend for superior healing and lesser bone mineral density declines in the immediate vs delayed group with no differences in adverse events.PurposeLittle clinical data are available on the use of teriparatide for the treatment of bisphosphonate-associated atypical femur fractures (AFF). The goal of the Fix-IT study was to determine if immediate therapy with teriparatide was superior for fracture healing after an AFF compared to a 6-month delay in teriparatide therapy.MethodsThis randomized pilot clinical trial included 13 women with an AFF who were randomized to immediate teriparatide vs a delay of 6 months. All were followed for 12 months on teriparatide. The primary outcomes included individual and composite measures of radiologic bone healing (scored 1 point [no healing] to 4 points [complete healing]) at 6 and 12 months. Secondary outcomes included bone mineral density of the unfractured contralateral hip, spine, 1/3 distal radius, and adverse events.ResultsWe found there was a trend for superior healing with the composite score (12.6 vs 11.2 at 6 months and 15.4 vs 13.2 at 12 months), and lesser bone mineral density declines at the 1/3 distal radius (12-month change − 1.9 vs − 6.1%) in the immediate vs the delayed group. There were no differences in adverse events. There was one implant failure in the delayed group.ConclusionsThere is a preliminary signal for greater improvements with immediate teriparatide therapy vs delayed therapy. However, because an AFF is a rare event, and only a small number of patients were included, the results must be interpreted with caution.

SummaryWe compared the effectiveness of promoting bone healing between two teriparatide preparations for atypical femoral fracture (AFF). A total of 45 AFFs were included in this study, and we compared the duration of bone union. Teriparatide administered by daily injection enhanced bone union more than weekly administration in complete AFFs.IntroductionThe efficacy of teriparatide for atypical femoral fracture (AFF) has been recently reported. Although two different teriparatide preparations can be used to treat osteoporosis in Japan, daily or weekly injection, all previous reports on the effectiveness of teriparatide for AFF only examined daily injection formulations. Therefore, we compared the promotion of bone healing between the two teriparatide preparations for AFF.MethodsA total of 45 consecutive AFFs in 43 Japanese patients were included in this study. They received either a daily 20-μg teriparatide injection (daily group; n = 32) or a once-a-week 56.5-μg teriparatide injection (weekly group; n = 13). We compared the clinical background and duration of bone union between these two groups.ResultsWhen all patents were included, the fracture healing time was not significantly different between the two groups. Only patients with complete AFFs had significantly fewer daily bisphosphonate or denosumab injections than the weekly group (P < 0.05). The fracture healing time in the daily group (6.1 ± 4.1 months) was significantly shorter than that in the weekly group (10.1 ± 4.2 months) (P < 0.05). Even if the influence of bisphosphonate or denosumab usage was excluded, a similar significant difference was observed in the fracture healing time (P < 0.05). There was no significant difference between the two groups among patients with incomplete AFFs.ConclusionsDaily teriparatide injections enhance bone union more than weekly injections in complete AFF patients.

Patients who were 50 years of age or older and had a displaced femoral neck fracture were randomly assigned to total hip arthroplasty or hemiarthroplasty. Total hip arthroplasty did not differ significantly from hemiarthroplasty with regard to the incidence of secondary procedures and led to clinically unimportant improvement over hemiarthroplasty in function over 24 months.

Background Displaced femoral neck fractures usually are treated with hemiarthroplasty. However, the degree to which the design of the implant used (cemented or uncemented) affects the outcome is not known and may be therapeutically important. Questions/purposes In this randomized controlled trial, we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of (1) Harris hip scores; (2) femoral fractures; (3) overall health outcomes using the Barthel Index and EQ-5D scores; and (4) complications, reoperations, and mortality since our earlier report on this cohort at 1-year followup. Methods We present followup at a median of 5 years after surgery (range, 56–65 months) from a randomized trial comparing a cemented hemiarthroplasty (112 hips) with an uncemented, hydroxyapatite-coated hemiarthroplasty (108 hips), both with a bipolar head. Results were previously reported at 1-year followup. Harris hip scores, Barthel Index, and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon. Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons. Sixty patients (56%) had died in the cemented group and 63 (60%) in the uncemented group. Respectively, three and two patients (2.7% and 1.9%) were completely lost to followup. Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group (86.2 versus 76.3; mean difference 9.9; 95% confidence interval [CI], 1.9–17.9). The prevalence of postoperative periprosthetic femoral fractures was 7.4% in the uncemented group and 0.9% in the cemented group (hazard ratio [HR], 9.3; 95% CI, 1.16–74.5). Barthel Index and EQ-5D scores were not different between the groups. Between 1 and 5 years, we found no additional infections or dislocations. The mortality rate was not different between the groups (HR, 1.2; 95% CI, 0.82–1.7). Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures. The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures. Level of Evidence Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Background Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, we plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect. Methods/design This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2–5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N  = 25) or BaG (S53P4) (study group, N  = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery. Discussion The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment. Trial registration German Clinical Trials Register (DRKS), ID: DRKS00013882 . Registered on 22 January 2018.

Background Fixation with a distal lateral femoral plate is a standard approach in treating osteoporotic or comminuted supracondylar femur fractures. However, in clinical practice, this method may prove inadequate, necessitating the application of a plate on the medial side of the distal femur. The aim of this study is to perform a biomechanical evaluation of the newly manufactured anatomically locked plate applied to the distal medial femoral condyle. Materials and methods The plate underwent 2 biomechanical tests by simulating an AO/OTA 33A3 type supracondylar fracture model on synthetic femur bones. The samples were divided into three groups. Fracture fixations were carried out on the medial side using the distal femur medial anatomical locking plate (DFMALP) in group A samples, on the lateral side using the distal femur lateral anatomical locking plate in group B samples, and on both sides in group C samples. Results In the axial compression test, stability was preserved 23% more in group C than in group B. During the cyclic axial compression test, total displacement was 21% less in group C than in group B. Group A was collapsed at early cycle degrees. Conclusion In our study, it was observed that the application of DFMALP in conjunction with the lateral plate in AO/OTA 33A3 fragmented supracondylar femur fractures significantly enhanced biomechanical fracture stability. Level of evidence This is a Level 2 prospective, randomized controlled study.

Aim. This study aimed at comparing the mechanical properties of conventional and locking dual plates in adjacent and orthogonal orientations for the surgical fixation of transverse femoral shaft fractures. It also assessed the failure mechanics after dual adjacent and orthogonal locking plate removal. Methods. Thirty-two composite femurs were transversally osteotomized and randomly assigned for fixation with either dual locking or compression plates in an adjacent or orthogonal configuration. Sixteen specimens were preloaded axially to 20 N and single-leg stance loads were simulated. The remaining sixteen constructs were subjected to torsional loads of 10 Nm at a rate of 10 Nm/s in external and internal rotation of the femoral head in relation to the knee. Overall combined rotational stiffness was calculated. Eight different specimens with no osteotomy underwent the same experiments after dual locked plate removal and were tested to failure in combined eccentric axial and torsional modes. Data were statistically processed using a two-tailed t-test and one-way analysis of variance for the comparison of means between two or more groups, respectively. Results. Orthogonal constructs were statistically stiffer in axial loading compared to their adjacent counterparts in both conventional and locking configurations (p<0.001). Dual locking plates provided higher torsional stiffness than conventional ones within each plate orientation (p<0.01). Neither axial/torsional strength nor failure loads differed between constructs that had adjacent or orthogonal dual locking plates instrumented and then removed (p>0.05). Conclusions. In both orthogonal and adjacent orientations, double locking plates provide higher stability than their dual conventional counterparts. Orthogonal dual plate configuration is more stable and biomechanically superior to dual adjacent plating for constructs fixed with either standard compression or locking plates.

Background There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo ® / Forsteo ® , recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing. Questions/purposes We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety. Methods We initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication. The two prospective, randomized double-blind, placebo-controlled Phase III studies were designed to evaluate the effect of subcutaneous teriparatide (20 μg/day) for 6 months versus placebo on fracture healing at 24 months. The trials were conducted concurrently with a planned enrollment of 1220 patients per trial. However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols. Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced). An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs. A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide). The combined program had very low power to detect the originally expected treatment effect but had approximately 80% power to detect a larger difference of 12% between treatment groups for risk of revision surgery. Results The proportion of patients undergoing revision surgery at 12 months was 14% (11 of 81) in the placebo group versus 17% (13 of 78) in the teriparatide group. Central Adjudication Committee review excluded two of these patients treated with placebo from the primary analysis. After exclusions, the proportion of patients who did not undergo revision surgery at 12 months (primary endpoint) was not different between the study and placebo groups, at 88% in the placebo group (90% CI, 0.79–0.93) versus 84% in the teriparatide group (90% CI, 0.75–0.90; p = 0.743). There also were no differences between groups in the proportion of patients achieving radiographic fracture healing at 12 months (75% [61 of 81] placebo versus 73% [57 of 78] teriparatide; odds ratio, 0.89; 90% CI, 0.46–1.72; p = 0.692) or in measures of pain control (such as pain during ambulation, 92% [55 of 62] placebo versus 91% [52 of 57] teriparatide; odds ratio, 0.91; 90% CI, 0.25–3.37; p = 0.681). The frequency of patients reporting adverse events was 49% [40 of 81] in the placebo group versus 45% [35 of 78] in the teriparatide group (p = 0.634) during the 6-month treatment period. Conclusions The small sample size limited this study’s power to detect potential differences, and the results are exploratory. With the patients available, teriparatide did not decrease the risk of revision surgery, improve radiographic signs of fracture healing, or decrease pain compared with the placebo. The adverse event data observed were consistent with the teriparatide safety profile. Functional and health outcome data from the studies may help improve our understanding of patients recovering from femoral neck fractures. Further large controlled studies are required to determine the effect of teriparatide on fracture healing. Level of Evidence Level II, prospective study.

Background The aim of this cadaveric study was to compare a polyaxial (NCB®, Zimmer) to a fixed-angle monoaxial locking plate (PERILOC®, Smith & Nephew) in comminuted fractures of the distal femur regarding stability of the construct. Up to date there is no published biomechanical data concerning polyaxial plating in cadaveric distal femurs. Methods Fourteen formalin fixed femora were scanned by dual-energy x-ray absorptiometry. As fracture model an unstable supracondylar comminuted fracture was simulated. Fractures were pairwise randomly fixed either with a mono- (group A) or a polyaxial (group B) distal femur plate. The samples were tested in a servohydraulic mechanical testing system starting with an axial loading of 200 N following an increase of 200 N in every step with 500 cycles in every sequence up to a maximum of 2 000 N. The end points were implant failure or relevant loss of reduction. Data records included for each specimen time, number of cycles, axial load and axial displacement. Statistical analysis was performed using the exact Wilcoxon signed rank test. Results The mean donor age at the time of death was 75 years. The bone mass density (BMD) of the femurs in both groups was comparable and showed no statistically significant differences. Five bones failed before reaching the maximum applied force of 2000 N. Distribution curves of all samples in both groups, showing the plastic deformation in relation to the axial force, showed no statistically significant differences. Conclusions Operative stabilization of distal femur fractures can be successfully and equally well achieved using either a monoaxial or a polyaxial locking plate. Polyaxial screw fixation may have advantages if intramedullary implants are present.

Background Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly. Methods This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group. Discussion The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible. Trial registration TrialRegister.nl, NTR6794 . Registered on 31 October 2017.