Fracture behavior of a composite of bone and calcium sulfate/hydroxyapatite.

Calcium sulfate/hydroxyapatite (CaS/HA) biomaterials have been investigated for use in several orthopedic applications. However, the mechanical interactions between the composite of CaS/HA and bone at the microscale are still unknown. The aim of this study was to determine if and how augmentation with CaS/HA alters the fracture behavior of bone. Eleven cylinders of trabecular bone were drilled from human femoral heads and cleaned from bone marrow. Among them, five cylinders were injected with CaS/HA to generate composite specimens, while the others were kept intact. One extra specimen of pure CaS/HA was prepared. All specimens were compressed in situ using synchrotron X-ray tomography and imaged at ∼2% strain intervals. Structural properties were calculated from the images in unloaded state and mechanical properties were determined from the load-curves. CaS/HA alone displayed the highest peak force and stiffness and the lowest strain at fracture. All composite specimens had a higher peak force than the pure bone specimens and the composite specimens had higher toughness than the pure CaS/HA specimen. Furthermore, the fracture behavior was analyzed further to characterize the local deformations. The pure bone specimens presented damage in multiple trabeculae and the CaS/HA specimen displayed sharp transition in strains, with low strain in one load step and large cracks in the next. The composite specimens deformed uniformly, with the CaS/HA preventing tissue damage and the bone preventing cracks in the CaS/HA from propagating through the specimen. In conclusion, using tomography with in situ loading, it was possible to show how CaS/HA can help prevent bone tissue damage before global failure.

A combined fracture and mortality risk index useful for treatment stratification in hip fragility fractures.

OBJECTIVES: In this study, we aimed to assess the stratification ability of the Fracture and Mortality Risk Evaluation (FAME) index for reoperation, new fragility fracture, and mortality during one-year follow-up. PATIENTS AND METHODS: Between November 2018 and July 2019, a total of 94 consecutive hip fragility fracture patients from two centers (20 males, 74 females; mean age: 79.3±8.9 years; range, 57 to 100 years) were retrospectively analyzed. The patients were classified into high, intermediate, and low fracture and mortality risk groups according to the Fracture Risk Assessment Tool (FRAX) score and Sernbo score, respectively, as well as nine combined categories according to the FAME index. Hospital records were reviewed to identify re-fractures (reoperations, implant failure, new fragility fractures on any site) and mortality at one year following the FAME index classification. RESULTS: Overall re-fracture and mortality rates were 20.2% and 33%, respectively. High fracture risk category (FRAX-H) was significantly associated with higher re-fracture (odds ratio [OR]: 2.9, 95% confidence interval [CI]: 1-8.2, p=0.037) and mortality rates compared to others (OR: 3.7, 95% CI: 1.5-9.3, p=0.003). The patients classified within the FRAX-H category (n=35) had different mortality rates according to their Sernbo classification; i.e., patients classified as low mortality risk (Sernbo-L) (n=17) had lower mortality rates compared to others in this group (n=18) (35.3% and 66.7%, respectively), indicating a low statistical significance (OR: 0.3, 95% CI: 0.1-1.1, p=0.063). Similarly, within patients classified in Sernbo-L category (n=64), those classified as high fracture risk (FRAX-H) (n=17) had significantly higher re-fracture rates compared to others in this group (n=47) (35.3% and 8.5%, respectively), (OR: 5.9; 95% CI: 1.4-24.5), (p=0.017). Multivariate logistic regression analyses adjusting for covariates (age, sex, length of hospital stay and BMI) yielded similar results. CONCLUSION: The FAME index appears to be a useful stratification tool for allocating patients in a randomized-controlled trial for augmentation of hip fragility fractures.

Augmenting a dynamic hip screw with a calcium sulfate/hydroxyapatite biomaterial.

Internal fixation failure in hip fractures can lead to reoperation. Calcium sulfate/hydroxyapatite (CaS/HA) is a biomaterial that can be used for augmenting fracture fixation. We aimed to determine whether an injection of 2 ml CaS/HA increases the fixation of a dynamic hip screw inserted in synthetic and human trabecular bone. The study consists of two parts: 1) synthetic bone blocks (n = 74), with three subgroups: empty (cannulated screw, no injection), cannulated, and fenestrated; and 2) osteoporotic human femoral heads (n = 29), with the same subgroups. The heads were imaged using µCT. Bone volume fraction, insertion angle, and head diameter were measured. Pullout tests were performed and peak force, stiffness, and work were measured. The fenestrated group showed increases in pullout strength compared to no injection in the synthetic blocks. The cannulated group showed a higher pullout strength in low-density blocks. In the femoral heads, the variation was larger and there were no significant differences between groups. The bone volume fraction correlated with the peak force and work, and the insertion angle correlated with the stiffness. CaS/HA can improve the fixation of a dynamic hip screw. For clinical use, spreading of the material around the threads of the screw must be ensured.

Combined fracture and mortality risk evaluation for stratifying treatment in hip fracture patients: A feasibility study.

OBJECTIVES: This study aims to test the feasibility of the Fracture and Mortality Risk Evaluation (FAME) Index. PATIENTS AND METHODS: Two academic centers in Lithuania and Turkey participated in this retrospective study conducted between November 2018 and July 2019. A total of 100 consecutive patients (22 males, 78 females; mean age 78.9 years; range, 45 to 100 years) with low energy proximal femur fractures admitted for surgery were included in the study. Fracture Risk Assessment tool (FRAX) and the Sernbo scores were calculated and patients were classified into one of the nine subcategories of the FAME Index. RESULTS: Demographics and FAME Index classifications were similar between centers. Patients with high risk of fracture and low risk of mortality accounted for 18% of all patients, which is the FAME Index subcategory to theoretically benefit from cancellous bone augmentation during internal fixation of a fragility hip fracture the most. CONCLUSION: The FAME Index was successfully applied in clinical emergency setting utilizing a simple form, and demonstrated promising potential in stratification of hip fractures most suitable for screw and device augmentation. Larger studies with at least one-year of follow-up are warranted to verify the validity of FAME Index.

Long-Term Response to a Bioactive Biphasic Biomaterial in the Femoral Neck of Osteoporotic Rats.

Osteoporosis often leads to fragility fractures of the hip, resulting in impaired quality of life and increased mortality. Augmenting the proximal femur could be an attractive option for prevention of fracture or fixation device failure. We describe a tissue engineering based strategy to enhance long-term bone formation in the femoral neck of osteoporotic rats by locally delivering bioactive molecules; recombinant human bone morphogenic protein-2 (rhBMP-2), and zoledronic acid (ZA) by using a calcium sulfate/hydroxyapatite (CaS/HA) biomaterial. A defect was created by reaming the femoral neck canal of osteoporotic (OVX) rats and they were treated as follows: G1. Empty, G2. CaS/HA, G3. CaS/HA+Systemic ZA, G4. CaS/HA+Local ZA, and G5. CaS/HA+Local ZA+rhBMP-2. Bone formation was evaluated 6 months after treatment. Further, radioactively labeled 14C-ZA was used to study the bioavailability of ZA at the defect location, which was determined by using scintillation counting. Micro-CT indicated significantly higher bone volume in groups G4 and G5 compared with the other treatment groups. This was confirmed qualitatively by histological assessment. Addition of rhBMP-2 gave no additional benefit in this model. Local delivery of ZA performed better than systemic administration of ZA. Mechanical testing showed no differences between the groups, likely reflecting that the addition of bioactive molecules had limited effect on cortical bone or the choice of mechanical testing setup was not optimal. Scintillation counting revealed higher amounts of 14C-ZA present in the treated leg of G4 compared with its contralateral control and compared with G3, indicating that local ZA delivery can be used to achieve high local concentrations without causing a systemic effect. This long-term study shows that local delivery of ZA using a CaS/HA carrier can regenerate cancellous bone in the femoral neck canal and has clear implications for enhancing implant integration and fixation in fragile bone.

Fracture strength of the proximal femur injected with a calcium sulfate/hydroxyapatite bone substitute.

BACKGROUND: Available interventions for preventing fragility hip fractures show limited efficacy. Injection of a biomaterial as bone substitute could increase the fracture strength of the hip. This study aimed to show the feasibility of injecting a calcium sulfate/hydroxyapatite based biomaterial in the femoral neck and to calculate the consequent change in strength using the finite element method. METHODS: Five patients were injected with 10 ml calcium sulfate/hydroxyapatite in their femoral neck. Quantitative CT scans were taken before and after injection. Five additional patients with fragility hip fractures were also scanned and the images from the non-fractured contralateral sides were used. Finite element models were created for all proximal femora with and without injection and the models were tested under stance and sideways fall loading until fracture. The change in fracture strength caused by the injection was calculated. Additionally, perturbations in volume, location, and stiffness of the injected material were created to investigate their contribution to the fracture strength increase. FINDINGS: The 10 ml injection succeeded in all patients. Baseline simulations showed theoretical fracture strength increases of 0-9%. Volume increase, change in location and increase in stiffness of the material led to increases in fracture strength of 1-27%, -8-26% and 0-17%, respectively. Altering the location of the injection to a more lateral position and increasing the stiffness of the material led to increases in fracture strength of up to 42%. INTERPRETATION: This study shows that an injection of calcium sulfate/hydroxyapatite is feasible and can theoretically increase the hip's fracture strength.

Calcium Sulphate/Hydroxyapatite Carrier for Bone Formation in the Femoral Neck of Osteoporotic Rats.

This study investigated bone regeneration in the femoral neck canal of osteoporotic rats using a novel animal model. A calcium sulphate (CS)/hydroxyapatite (HA) carrier was used to deliver a bisphosphonate, zoledronic acid (ZA), locally, with or without added recombinant human bone morphogenic protein-2 (rhBMP-2). Twenty-eight-week-old ovariectomized Sprague-Dawley rats were used. A 1 mm diameter and 8 mm long defect was created in the femoral neck by drilling from the lateral cortex in the axis of the femoral neck, leaving the surrounding cortex intact. Three treatment groups and one control group were used: (1) CS/HA alone, (2) CS/HA + ZA (10 µg) (3) CS/HA + ZA (10 µg) + rhBMP-2 (4 µg), and (4) empty defect (control). The bone formation was assessed at 4 weeks post surgery using in vivo micro computed tomography (micro-CT). At 8 weeks post surgery, the animals were sacrificed, and both defect and contralateral femurs were subjected to micro-CT, mechanical testing, and histology. Micro-CT results showed that the combination of CS/HA with ZA or ZA + rhBMP-2 increased the bone formation in the defect when compared to the other groups and to the contralateral hips. Evidence of new dense bone formation in CS/HA + ZA and CS/HA + ZA + rhBMP-2 groups was seen histologically. Mechanical testing results showed no differences in the load to fracture between the treatments in either of the treated or contralateral legs. The CS/HA biomaterial can be used as a carrier for ZA and rhBMP-2 to regenerate bone in the femoral neck canal of osteoporotic rats.

Excellent long-term results of the Müller acetabular reinforcement ring in primary total hip arthroplasty: A prospective study on radiology and survival of 321 hips with a mean follow-up of 11 years.

BACKGROUND AND PURPOSE: The original Müller acetabular reinforcement ring (ARR) shows favorable medium-term results for acetabular reconstruction in total hip arthroplasty, where it is used when the acetabular bone stock is deficient. However, there are no data regarding long-term survival of the device. We therefore investigated long-term survival and analyzed radiological modes of failure. PATIENTS AND METHODS: Between 1984 and 2002, 321 consecutive primary arthroplasties using an ARR were performed in 291 patients. The mean follow-up time was 11 (0-25) years, and 24 hips were lost to follow-up. For survival analysis, we investigated 321 hips and the end of the follow-up was the date of revision, date of death, or the last patient contact date with implant still in situ. Radiological assessment was performed for 160 hips with a minimum of 10 years of follow-up and with radiographs of sufficient quality. It included evaluation of osteolysis, migration, and loosening. RESULTS: 12 ARR THAs were revised: 1 isolated ARR revision for aseptic loosening, 4 revisions of the ARR and the stem for aseptic loosening, 6 for infection, and 1 for recurrent dislocation. The cumulative revision rate for all components, for any reason, at 20 years was 15% (95% CI: 10-22), while for the ARR only it was 7% (95% CI: 4-12) for any reason and 3.4% (95% CI: 1-9) for aseptic loosening. 21 (13%) of 160 ARR THAs examined had radiological changes: 7 had osteolysis but were not loose, and 14 were radiologically loose but were not painful and not revised. INTERPRETATION: Our data suggest that the long-term survival of the ARR is excellent.

Moderate varus/valgus malalignment after total knee arthroplasty has little effect on knee function or muscle strength.

BACKGROUND AND PURPOSE: Postoperative muscle strength and component alignment are important factors affecting functional results after total knee arthroplasty (TKA). We are not aware of any studies that have investigated the relationship between them. We therefore investigated whether coronal malalignment of the mechanical axis and/or of individual implant components would affect knee muscle strength and function 1 year after TKA surgery. PATIENTS AND METHODS: We included 120 consecutive osteoarthritis (OA) patients admitted for TKA. Preoperative active range of motion (ROM) of the knee, patient age, sex, and BMI were recorded and the Knee Society score (KSS) and knee joint extensor/flexor muscle strength were assessed. At 1-year follow-up, the mechanical and coronal component alignment was measured from a postoperative long standing radiograph, and ROM, KSS, and muscle strength measurements were taken in 91 patients. Functional outcome and muscle strength measurements were compared between normally aligned and malaligned TKA groups. RESULTS: 29 of 91 TKAs were malaligned, i.e. they deviated more than 3° from the neutral mechanical axis. 18 femoral components and 15 tibial components were malaligned. Before surgery, the malaligned and normally aligned groups were similar regarding sex distribution, BMI, ROM, KSS, and muscle strength. At the 1-year follow-up, the differences between the groups regarding knee joint function and muscle strength were small, not statistically significant, and barely clinically relevant. INTERPRETATION: Moderate varus/valgus malalignment of the mechanical axis or of individual components has no relevant clinical effect on function or muscle strength 1 year after TKA surgery.