Introduction. We evaluated the osteogenic potential of a novel biomimetic bone paste (DBSint®), made of a combination of a human demineralized bone matrix (hDBM) and a nano-structured magnesium-enriched hydroxyapatite (Mg-HA), in a standardized clinical model of high tibial osteotomy for genu varus. Methods. A prospective, randomized, controlled study was performed and thirty patients were enrolled and assigned to three groups: DBSint® (Group I), nano-structured Mg-HA (SINTlife®) (Group II) and lyophilized-bone-chips (Group III). Six weeks after surgery, computed tomography-guided biopsies of the grafts were performed. Clinical/radiographic evaluation was performed at six weeks, twelve weeks, six months, one and 2 year after surgery, in order to verify if the graft type influenced the healing rate. Results. By histomorphometry, DBSint® was shown able to promote a quick and effective bone tissue regeneration, superior to the healing process occurred in presence of SINTlife® and lyophilized bone chips. At a mean follow up of 32,59 months, no statistical differences between the groups were found, both pre-and post-operatively, according to the Knee Society Scoring System. Mean time of ostointegration was 3,9 months in the DBSint® group, 4,2 months in the lyophilized-bone group and 4,5 in the SINTlife® group. Discussion/conclusion. Orthopedic practice may be adversely affected by an inadequate bone repair that might compromise the success of surgery. Therapy for bone regeneration with DBSint® could be particularly attractive in the treatment of patients with bone defects difficult to heal, where it could shorten the period necessary for bone regeneration, due to the higher osteogenetic potential

Several bisphosphonates are now available for the treatment of osteoporosis. Porous hydroxyapatite/collagen (HA/Col) composite is an osteoconductive bone substitute which is resorbed by osteoclasts. The effects of the bisphosphonate alendronate on the formation of bone in porous HA/Col and its resorption by osteoclasts were evaluated using a rabbit model. Porous HA/Col cylinders measuring 6 mm in diameter and 8 mm in length, with a pore size of 100 μm to 500 μm and 95% porosity, were inserted into a defect produced in the lateral femoral condyles of 72 rabbits. The rabbits were divided into four groups based on the protocol of alendronate administration: the control group did not receive any alendronate, the pre group had alendronate treatment for three weeks prior to the implantation of the HA/Col, the post group had alendronate treatment following implantation until euthanasia, and the pre+post group had continuous alendronate treatment from three weeks prior to surgery until euthanasia. All rabbits were injected intravenously with either saline or alendronate (7.5 μg/kg) once a week. Each group had 18 rabbits, six in each group being killed at three, six and 12 weeks post-operatively. Alendronate administration suppressed the resorption of the implants. Additionally, the mineral densities of newly formed bone in the alendronate-treated groups were lower than those in the control group at 12 weeks post-operatively. Interestingly, the number of osteoclasts attached to the implant correlated with the extent of bone formation at three weeks. In conclusion, the systemic administration of alendronate in our rabbit model at a dose-for-weight equivalent to the clinical dose used in the treatment of osteoporosis in Japan affected the mineral density and remodelling of bone tissue in implanted porous HA/Col composites

Background. An increasing number of hip prostheses are inserted without bone cement. Experimental research has shown that hydroxyapatite (HA) coated implants are strongly fixated in the bone, which is believed to reduce the likelihood of prosthetic loosening. However, in recent years, there has been much debate about the role of HA particles in third-body polyethylene (PE) wear and formerly we have shown the revision rate to be high among older-design HA coated cups. Purpose. We hypothesized increased PE wear-rate using HA coated acetabular components in comparison with non-HA coated components (control group). Materials and Methods. We performed a retrospective comparative clinical study based on two patient populations identified in the Danish Hip Arthroplasty Registry (October 2006). All patients had primary total hip arthroplasty (THA) between 1997 and 2001 with cementless Mallory-Head acetabular components. One group received HA coated acetabular components (75 patients, 77 hips). The other group received identical components without HA (70 patients, 73 hips). In all cases the liner was similar and 28 mm metal femoral heads were used. All patients were invited for a radiographic follow-up in 2007. The AP radiographs were analysed for two-dimensional (2D) polyethylene wear using the semi-automated PolyWare software. All cases of non-responders, stem revisions, hip dislocations and patients with less than 5 years of follow-up were excluded from the analysis. Findings/Results. The 2D linear PE wear-rate of 0.18 mm/year (SD 0.09) was higher (P<0.001) in the group with HA coated cups (n = 54) compared with 0.12 mm/year (SD 0.07) in the group of non-HA coated cups (n = 35). The Effect size of the difference in linear PE wear-rate, established as Cohen's d, was large (0.9). The time of follow-up was similar (p = 0.11) in the HA group (7.2 years) versus the non-HA group (7.6 years). There was no case-mix concerning distribution of gender and operated side in the groups; however, the mean age was lower (P = 0.001) in the HA group (57 years) compared with the non-HA group (63 years). Conclusions. We found a significantly increased PE wear rate in HA coated acetabular components at midterm follow-up. The patients with HA coated cups were younger on average, and this might partly explain the findings because the activity level expectedly is higher in younger patients. Still an effect size of 0.9 is large and should raise concern and supplement considerations in future clinical decisions on component selection. A randomized (RSA) study on newer type crosslinked polyethylene liners is recommended to bring about more information on the clinical performance and longevity of HA coated acetabular components

Aims. Will Hydroxyapatite hip (HA) arthroplasty associated with ceramic bearings produce uncomplicated function in younger, active patients’ The incidence of aseptic loosening, dislocation and broken implants has been particularly investigated. Debris disease from plastic debris contributes to aseptic loosening. Hard-Hard bearings should obviate this problem. Metal-metal will release ions which might be deleterious. Experience with metal-metal resurfacing has high lighted problems including pseudo-tumours. Ceramic bearings may fracture but otherwise appear free of complications. Methods. This is a study extending over 19 years of 626 HA hip arthroplasties with ceramic bearings. Annual review using Harris Hip Score to assess pain and function and X-rays to check osseointegration has been performed. Alumina ceramic was inserted in 467 hips. The newer Zirconia Toughened Alumina (ZTA) has been inserted in 169 hips. There are 118 hips still under review at 10 or more years. Results. Aseptic loosening is unusual (one stem, two acetabulae (3 of 1252 components, 0.24%) Failure from mal-orientation with repeated dislocation occurred in six hips (0.96%). Three alumina heads (0.48%) and two alumina liners (0.32%) broke. There has been no failure of ZTA ceramic. No patients have thigh pain. Osteolysis and debris disease have not arisen. Harris Hip Scores show 91.2% scoring over 90 or 100. Lower scores mostly relate to other joint and medical problems. Conclusions. Assessments confirm that patients remain well. Aseptic loosening of HA hips is rare at 0.24%. Failure from broken alumina components is unusual. Alumina has now been superseded by ZTA for implantation. Ceramic on ceramic is a reliable selection for bearing surfaces in patients of any age and either sex

Aims

The Intraosseous Transcutaneous Amputation Prosthesis (ITAP) may improve quality of life for amputees by avoiding soft-tissue complications associated with socket prostheses and by improving sensory feedback and function. It relies on the formation of a seal between the soft tissues and the implant and currently has a flange with drilled holes to promote dermal attachment. Despite this, infection remains a significant risk. This study explored alternative strategies to enhance soft-tissue integration.

Osteoinductive bone substitutes are in their developmental infancy and a paucity of effective grafts options persists despite clinical demand. Bone mineral substitutes such as hydroxyapatite cause minimal biological activity when compared to osteoinductive systems present biological growth factors in order to drive bone regeneration. We have previously demonstrated the in-vitro efficacy of a bioengineered system at presenting growth factors at ultra low-doses. This study aimed to translate this growth factor delivery system towards a clinically applicable implant. Osteoinductive surfaces were engineered using plasma polymerisation of poly(ethyl acrylate) onto base materials followed by adsorption of fibronectin protein and subsequently growth factor (BMP-2). Biological activity following ethylene oxide (EO) sterilisation was evaluated using ELISAs targeted against BMP-2, cell differentiation studies and atomic force microscopy. Scaffolds were 3D printed using polycaprolactone/hydroxyapatite composites and mechanically tested using a linear compression models to calculate stress/strain. In-vivo analysis was performed using a critical defect model in 23 mice over an 8 week period. Bone formation was assessed using microCT and histological analysis. Finally, a computer modelling process was developed to convert patient CT images into surface models, then formatted into 3D-printable scaffolds to fill critical defects. Following EO sterilisation, there was no change in scaffold surface and persistent availability of growth factors. Scaffolds showed adequate porosity for cell migration with mechanical stiffness similar to cancellous bone. Finally, the in vivo murine model demonstrated rapid bone formation with evidence of trabecular remodelling in samples presenting growth factors compared to controls

Aims

The aim of this study was to report the three-year follow-up for a series of 400 patients with a displaced intracapsular fracture of the hip, who were randomized to be treated with either a cemented polished tapered hemiarthroplasty or an uncemented hydroxyapatite-coated hemiarthroplasty.

Aims

Musculoskeletal infection is a devastating complication in both trauma and elective orthopaedic surgeries that can result in significant morbidity. Aim of this study was to assess the effectiveness and complications of local antibiotic impregnated dissolvable synthetic calcium sulphate beads (Stimulan Rapid Cure) in the hands of different surgeons from multiple centres in surgically managed bone and joint infections.

Aims

Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade.

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Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures.

Nanoscale topography increases the bioactivity of a material and stimulates specific responses (third generation biomaterial properties) at the molecular level upon first generation (bioinert) or second generation (bioresorbable or bioactive) biomaterials. We developed a technique (based upon the effects of nanoscale topography) that facilitated the in vitro expansion of bone graft for subsequent implantation and investigated the optimal conditions for growing new mineralised bone in vitro. Two topographies (nanopits and nanoislands) were embossed into the bioresorbable polymer Polycaprolactone (PCL). Three dimensional cell culture was performed using double-sided embossing of substrates, seeding of both sides, and vertical positioning of substrates. The effect of Hydroxyapatite, and chemical stimulation were also examined. Human bone marrow was harvested from hip arthroplasty patients, the mesenchymal stem cells culture expanded and used for cellular analysis of substrate bioactivity. The cell line specificity and osteogenic behaviour was demonstrated through immunohistochemistry, confirmed by real-time PCR and quantitative PCR. Mineralisation was demonstrated using alizarin red staining. Results showed that the osteoinduction was optimally conferred by the presence of nanotopography, and also by the incorporation of hydroxyapatite (HA) into the PCL. The nanopit topography and HA were both superior to the use of BMP2 in the production of mineralised bone tissue. The protocol from shim production to bone marrow harvesting and vertical cell culture on nanoembossed HaPCL has been shown to be reproducible and potentially applicable to economical larger scale production

Objectives. Deep bone and joint infections (DBJI) are directly intertwined with health, demographic change towards an elderly population, and wellbeing. The elderly human population is more prone to acquire infections, and the consequences such as pain, reduced quality of life, morbidity, absence from work and premature retirement due to disability place significant burdens on already strained healthcare systems and societal budgets. DBJIs are less responsive to systemic antibiotics because of poor vascular perfusion in necrotic bone, large bone defects and persistent biofilm-based infection. Emerging bacterial resistance poses a major threat and new innovative treatment modalities are urgently needed to curb its current trajectory. Materials and Methods. We present a new biphasic ceramic bone substitute consisting of hydroxyapatite and calcium sulphate for local antibiotic delivery in combination with bone regeneration. Gentamicin release was measured in four setups: 1) in vitro elution in Ringer’s solution; 2) local elution in patients treated for trochanteric hip fractures or uncemented hip revisions; 3) local elution in patients treated with a bone tumour resection; and 4) local elution in patients treated surgically for chronic corticomedullary osteomyelitis. Results. The release pattern in vitro was comparable with the obtained release in the patient studies. No recurrence was detected in the osteomyelitis group at latest follow-up (minimum 1.5 years). Conclusions. This new biphasic bone substitute containing antibiotics provides safe prevention of bone infections in a range of clinical situations. The in vitro test method predicts the in vivo performance and makes it a reliable tool in the development of future antibiotic-eluting bone-regenerating materials. Cite this article: M. Stravinskas, P. Horstmann, J. Ferguson, W. Hettwer, M. Nilsson, S. Tarasevicius, M. M. Petersen, M. A. McNally, L. Lidgren. Pharmacokinetics of gentamicin eluted from a regenerating bone graft substitute: In vitro and clinical release studies. Bone Joint Res 2016;5:427–435. DOI: 10.1302/2046-3758.59.BJR-2016-0108.R1

Aim. Previous studies of primary internal fixation of infected non-unions have reported high failure rates. Local antibiotic carriers and coatings have been advocated to reduce infection around implants and allow bone healing. We evaluated the effect of a calcium sulphate/hydroxyapatite antibiotic-loaded composite on bone healing and the eradication of infection in combination with internal fixation. Method. Twelve cases of established infected non-union, with segmental bone loss of up to 1cm were treated using a multidisciplinary protocol. This included; excision, deep sampling, stabilisation, local and systemic antibiotics, and soft-tissue closure. We treated 5 femurs, 4 humeri, 1 tibia and 2 periarticular non-unions at the ankle. Mean age was 59.8 years (34–75) and 9 patients had systemic co-morbidities (C-M Type B hosts). 9 patients had single stage surgery, with 5 IM Nails and 4 plates. Three patients had planned second stage internal fixation after external fixation to correct deformity. Staph. aureus was the commonest pathogen (5 cases) with polymicrobial infection in 3 cases. Results. All 12 patients were infection-free at a mean follow-up of 23 months (range 13–34 months). Union was achieved in 11/12 (92%) with the primary surgery alone. The single failure was the tibial case, who remains with an infection-free, stiff non-union. Conclusion. This protocol offered good results, mainly with a single stage treatment. Primary internal fixation was possible in 9 cases, without recurrent infection. The combination of excision of infected dead bone and a high level of local antibiotics above the Minimum Inhibitory Concentration and Minimum Biofilm Eradication Concentration levels for common bacteria, allowed a high success rate in these difficult cases

Aims. The use of local antibiotic carriers in the treatment of chronic osteomyelitis is an important adjunct in dead space management. We present the outcomes of two different biodegradable antibiotic carriers used in the management of chronic osteomyelitis. Method. A single centre series between 2006–2017. The initial cohort (2006–2010) of 137 cases, Group A, had Osteoset® T (calcium sulphate carrier containing tobramycin). The second cohort (2013–1017) of 160 cases, group B, had CeramentTM G (biphasic calcium sulphate, nano-crystalline hydroxyapatite carrier containing gentamicin). Only Cierny-Mader Grade III and IV cases were included with a minimum six-month radiographic follow-up. Infection recurrence rate, wound leakage, subsequent fracture involving the treated segment, and radiographic void filling were assessed at a minimum of 6 months following surgery. Results. Mean follow-up in Group A was 2.5 yrs (0.5–10.5) and in Group B it was 1.4 yrs (0.6–4.7). Group A had a significantly higher rate of infection recurrence (16/137 (11.7%) Vs. 7/160 (4.4%) p=0.0278), wound leakage (26/137 (19.0%) Vs. 16/160 (10.0%) p=0.0304) and subsequent fracture rate (11/137 (8.0%) Vs. 3/160 (1.9%) p=0.0143) compared to Group B. Average time to recurrence was 1.07 years (0.1–2.6) in Group A and 1.02 (0.2–2.1) in Group B. The mean bone void healing in Group B was significantly better than Group A (73.2% Vs. 40.0%, p <0.00001). Conclusions. Cerament™ G has significantly better bone healing compared to a calcium sulphate carrier and was associated with a lower rate of recurrent infection, wound leakage and subsequent fracture risk

The previous bioabsorbable plates have had several issues with regard to clinical usage for fractures. The aims of this study were to demonstrate the clinical results of novel bioabsorbable plates made of hydroxyapatite/poly-L-lactide and titanium plates for metacarpal fractures and to compare mechanical properties of them in a fracture model. The subjects were 33 metacarpal diaphyseal fractures of 27 consecutive patients treated with bioabsorbable plates. The mean age was 35.8 (17–78), 22 male and 5 female was included. The mean follow up period was 7.4months (2–14). All cases achieved bone union, and there were no complication especially for aseptic swelling etc. Furthermore, we compared the mechanical properties of bioabsorbable and titanium plates. There were no significant differences in 6 month postoperative clinical results including total range of active motion and % of the contralateral grip strength between patients receiving bioabsorbable and titanium plates. The bending strength and stiffness of one-third tubular bioabsorbable plate constructs were comparable with those of titanium plates for 1.5mm screws, and those of semi-tubular bioabsorbable plates were comparable with those of titanium plates for 2.0mm screws. The torsional strength of semi-tubular bioabsorbable plates was significantly greater than that of titanium plates for 2.0mm screws

Aims

The purpose of this study was to: review the efficacy of the induced membrane technique (IMT), also known as the Masquelet technique; and investigate the relationship between patient factors and technique variations on the outcomes of the IMT.

Bioactive glasses (BAGs) are bone substitutes with bone bonding, angiogenesis promoting and antibacterial properties. The bioactive process leading to bone bonding has been described as a sequence of reactions in the glass and at its surface. Implantation of the glass is followed by a rapid exchange of Na+ in the glass with H+ and H3O+ from the surrounding tissue, leading to the formation of silanol (SiOH) groups at the glass surface. Due to migration of Ca2+ and PO43− groups to the surface and cystallization, a CaO-P2O5 hydroxyapatite (HA) layer is formed on top of the Si-rich layer. Finally, cell interactions with the HA layer subsequently initiate the bone forming pathway. The rapid increase in pH and the subsequent osmotic effect caused by dissolution of the glass have been suggested to partly explain the antibacterial properties observed for BAGs. Comparing bactericidal effects of different BAGs, BAG-S53P4 has been shown to be the most effective, with the fastest killing or growth inhibitory effect. This antibacterial effect has been observed in vitro for all pathogens tested, including the most important aerobic and anaerobic pathogens, as well as very resistant bacteria. In a multicentre study in 2007–2009, BAG-S53P4 was used as bone graft substitute in treatment of osteomyelitis. Eleven patients (nine males, two females) with a radiologically diagnosed osteomyelitis in the lower extremity (N=10) and in the spine (N-1) participated. In the operation, the infected bone and the soft tissue were removed, and the cavitary bone defects were filled with BAG-S53P4 (BonAlive™, Bonalive Biomaterials Ltd., Finland). In four patients, muscle flaps were used as part of the treatment. Eight patients were treated in a one-stage procedure. Kanamycin granules were used in one patient and Garamycin granules (Septocol ®) in two patients. Patient data were obtained from hospital patient' records until August 2010, resulting in a mean follow-up period of 29 months (range 15–43). BAG-S53P4 was well tolerated; no BAG-related adverse effects were seen in any patient. The use of BAG-S53P4 as a bone graft substitute resulted in a fast recovery. Long-term clinical outcome was good or excellent in ten of eleven patients. These primary results indicate that BAG-S53P4 can be considered as a good and usable material in treatment of osteomyelitis. After this study BAG-S53P4 has been used in several other patients with very promising results

Introduction. The MITCH PCR is an anatomic, flexible, horse-shoe shaped acetabular component, with 2 polar fins. The rationale of the PCR cup design is to reproduce a near-physiological stress distribution in the bone adjacent to the prosthesis. The thin composite cup is designed to fuse and flex in harmony with the surrounding bony structure. Only the pathological acetabular cartilage and underlying subchondral bone of the horseshoe-shaped, load-bearing portion of the acetabular socket is replaced, thus preserving viable bone stock. The PCR is manufactured from injection moulded carbon fibre reinforced polyetheretherketone (PEEK), with a two layer outer surface comprising hydroxyapatite and plasma sprayed commercially pure titanium. It is implanted in conjunction with a large diameter low wear femoral head, producing a bearing that will generate minimal wear debris with relatively inert particles. Pre-clinical mechanical testing, finite element analysis and biocompatibility studies have been undertaken. FEA evaluation predicts preservation of host bone density in the load bearing segments. A pilot clinical study was completed on a proto-type version of the PCR cup (the “Cambridge” cup), achieving excellent 5 and 10 year results. Subjects and Methods. We report the three-year results from a two-centre, prospective clinical evaluation study of the MITCH PCR cup. Patient outcome has been assessed using standardised clinical and radiological examinations and validated questionnaires. The change in physical level of activity and quality of life has been assessed using the Oxford Hip Score, Harris Hip score and the EuroQol-5D score, at scheduled time-points. Serial radiographs have been analysed to monitor the fixation and stability of the components. Results and Conclusions. In total 25 PCR cups were implanted by 3 surgeons. There were 12 men and 13 women. The mean patient age at time of surgery was 67 years (range 57–74). An Accolade TMZF stem was used as the femoral component in 19 patients and an Exeter stem in 6. The mean Oxford Hip score improved from 19.8 pre-operatively to 45 at the latest follow-up. The mean Euroqol-5D score improved from 62.6 to 83.6 and the Harris Hip score improved from 49.9 to 90.6. Three adverse events were noted in 2 patients (2 chest infections and 1 deep vein thrombosis). One revision of the acetabular component was performed at 21 months for squeaking. This has been investigated and modification of the articular geometry has resolved the problem on in-vitro testing

Introduction. Spinal aBMD only explains 50–80% of vertebral strength, and the application of aBMD measurements in isolation cannot accurately identify individuals who are likely to eventually experience bone fracture, due to the low sensitivity of the test. For appropriate treatment intervention, a more sensitive test of bone strength is needed. Such a test should include not only bone mineral density, but also bone quality. Quantitative computed tomography-based finite element methods (QCT/FEM) may allow structural analyses taking these factors into consideration to accurately predict bone strength (PBS). To date, however, basic data have not been reported regarding the prediction of bone strength by QCT/FEM with reference to age in a normal population. The purpose of this study was thus to create a database on PBS in a normal population as a preliminary trial. With these data, parameters that affect PBS were also analyzed. Methods. Participants in this study comprised individuals who participated in a health checkup program with CT at our hospital in 2009. Participants included 217 men and 120 women (age range, 40–89 years). Exclusion criteria were provided. Scan data of the second lumber vertebra (L2) were isolated and taken from overall CT data for each participant obtained with simultaneous scans of a calibration phantom containing hydroxyapatite rods. A FE model was constructed from the isolated data using Mechanical Finder software. For each of the FE models, A uniaxial compressive load with a uniform distribution and uniform load increment was applied. For each participant, height and weight were measured, BMI was calculated. Simple linear regression analysis was used to estimate correlations between age and PBS as analyzed by QCT/FEM. Changes in PBS with age were also evaluated by grouping participants into 5-year age brackets. One-way analysis of variance was used to compare average PBS for participants in each age range. Mean PBS in the 40–44 year age range was taken as the young adult mean (YAM). The ratio of mean PBS in each age group to YAM was calculated as a percentage. A multivariate statistical technique was used to determine how PBS was affected by age, height, weight, and BMI. Result/Discussion. Mean PBS was lower in women than in men for all age ranges. PBS in men and women significantly decreased with age. Simple linear regression between age and PBS showed the annual rate of decline in PBS was 55 N/year in men and 164 N/year in women. Mean PBS in the 75–79 year age range was 77% of YAM in men and in women, that in the 70–79 year age range was 47% of YAM. PBS was strongly dependent on age, while physical status had less effect

Aims

Complex displaced osteoporotic acetabular fractures in the elderly are associated with high levels of morbidity and mortality. Surgical options include either open reduction and internal fixation alone, or combined with total hip arthroplasty (THA). There remains a cohort of severely comorbid patients who are deemed unfit for extensive surgical reconstruction and are treated conservatively. We describe the results of a coned hemipelvis reconstruction and THA inserted via a posterior approach to the hip as the primary treatment for this severely high-risk cohort.