Stable fixation of an ultra-short femoral neck-preserving hip prosthesis: a 5-year RSA, DXA, and clinical prospective outcome study of 48 patients.

BACKGROUND AND PURPOSE: We previously showed promising primary stability and preservation of bone stock with the ultra-short neck-loading hip implant in total hip arthroplasty (THA). The aim of this study was to evaluate clinical outcome, implant stability, and bone mineral density (BMD). METHODS: 50 patients were treated with the ultra-short neck Primoris hip implant at baseline and 48 were available for evaluation at 5-year follow-up. 5 different patient-reported outcome measures (PROMs) including hip-specific scores, disease-specific and generic quality of life outcome measures, and an activity score were used. Furthermore, implant stability using radiostereometric analysis (RSA) and assessment of periprosthetic BMD using dual-energy X-ray absorptiometry (DXA) were applied. RESULTS: By 1-year follow-up, all PROMs showed improvements and remained high at 5-year follow-up. After initial distal translation (subsidence) and negative rotation around the z-axis (varus tilt) the implant showed stable fixation at 5-year follow-up with no further migration beyond 12 months. In the regions of interest (ROI) 3 and 4, BMD remained stable. In ROI 2, further bone loss of 12% was found at 5-year follow-up. CONCLUSION: Clinical outcome including PROMs was satisfying throughout the 5-year follow-up period. The hip implant remains stable with both bone preservation and loss 5 years after surgery.

Mesenchymal stromal cells and platelet-rich plasma promote tendon allograft healing in ovine anterior cruciate ligament reconstruction.

PURPOSE: The effect of bone marrow mesenchymal stromal cells (BMSCs) and platelet-rich plasma (PRP) on tendon allograft maturation in a large animal anterior cruciate ligament (ACL) reconstruction model was reported for the first time. It was hypothesised that compared with non-augmented ACL reconstruction, BMSCs and PRP would enhance graft maturation after 12 weeks and this would be detected using magnetic resonance imaging (MRI). METHODS: Fifteen sheep underwent unilateral tendon allograft ACL reconstruction using aperture fixation and were randomised into three groups (n = 5). Group 1 received 10 million allogeneic BMSCs in 2 ml fibrin sealant; Group 2 received 12 ml PRP in a plasma clot injected into the graft and bone tunnels; and Group 3 (control) received no adjunctive treatment. At autopsy at 12 weeks, a graft maturation score was determined by the sum for graft integrity, synovial coverage and vascularisation, graft thickness and apparent tension, and synovial sealing at tunnel apertures. MRI analysis (n = 2 animals per group) of the signal-noise quotient (SNQ) and fibrous interzone (FIZ) was used to evaluate intra-articular graft maturation and tendon-bone healing, respectively. Spearman's rank correlation coefficient (r) of SNQ, autopsy graft maturation score and bone tunnel diameter were analysed. RESULTS: The BMSC group (p = 0.01) and PRP group (p = 0.03) had a significantly higher graft maturation score compared with the control group. The BMSC group scored significantly higher for synovial sealing at tunnel apertures (p = 0.03) compared with the control group. The graft maturation score at autopsy significantly correlated with the SNQ (r = - 0.83, p < 0.01). The tunnel diameter of the femoral tunnel at the aperture (r = 0.883, p = 0.03) and mid-portion (r = 0.941, p = 0.02) positively correlated with the SNQ. CONCLUSIONS: BMSCs and PRP significantly enhanced graft maturation, which indicates that orthobiologics can accelerate the biologic events in tendon allograft incorporation. Femoral tunnel expansion significantly correlated with inferior maturation of the intra-articular graft. The clinical relevance of this study is that BMSCs and PRP enhance allograft healing in a translational model, and biological modulation of graft healing can be evaluated non-invasively using MRI.

Effect of Bearing Type on Taper Material Loss in Hips From 1 Manufacturer.

BACKGROUND: Numerous studies have reported on clinical significant volumes of material loss and corrosion at the head-stem junction of metal-on-metal (MOM) hips; less is understood about metal-on-polyethylene (MOP) hips. We compared the effect of bearing type (MOM vs MOP) on taper material loss for a hip system of a single design. METHODS: In this cohort study, we recruited retrieved MOM (n = 30) and MOP (n = 22) bearing hips that were consecutively received at our center. We prospectively collected associated clinical and imaging data. We measured the severity of corrosion and volumes of material loss at each head taper surface and used multivariate statistical analysis to investigate differences between the 2 bearing types. RESULTS: The median rate of material loss for the MOM and MOP groups was 0.81 mm3/y (0.01-3.45) and 0.03 mm3/y (0-1.07), respectively (P < .001). Twenty-nine of 30 MOM hips were revised for adverse metal reactions, compared with 1 of 22 MOP hips. CONCLUSION: MOP hips lost significantly less material from their taper junctions than MOM hips. Our results can reassure patients with MOP Pinnacle hips that they are unlikely to experience clinically significant problems related to material loss from the taper junction.

The effectiveness of demineralized cortical bone matrix in a chronic rotator cuff tear model.

BACKGROUND: The purpose of this study was to assess the effect of demineralized bone matrix (DBM) on rotator cuff tendon-bone healing. The hypothesis was that compared with a commercially available dermal matrix scaffold, DBM would result in a higher bone mineral density and regenerate a morphologically superior enthesis in a rat model of chronic rotator cuff degeneration. METHODS: Eighteen female Wistar rats underwent unilateral detachment of the supraspinatus tendon. Three weeks later, tendon repair was carried out in animals randomized into 3 groups: group 1 animals were repaired with DBM (n = 6); group 2 received augmentation with the dermal scaffold (n = 6); and group 3 (controls) underwent nonaugmented tendon-bone repair (n = 6). Specimens were retrieved at 6 weeks postoperatively for histologic analysis and evaluation of bone mineral density. RESULTS: No failures of tendon-bone healing were noted throughout the study. All groups demonstrated closure of the tendon-bone gap with a fibrocartilaginous interface. Dermal collagen specimens exhibited a disorganized structure with significantly more abnormal collagen fiber arrangement and cellularity than in the DBM-based repairs. Nonaugmented repairs exhibited a significantly higher bone mineral density than in DBM and the dermal collagen specimens and were not significantly different from control limbs that were not operated on. CONCLUSION: The application of DBM to a rat model of chronic rotator cuff degeneration did not improve the composition of the healing enthesis compared with nonaugmented controls and a commercially available scaffold. However, perhaps the most important finding of this study was that the control group demonstrated a similar outcome to augmented repairs.

Fretting and Corrosion Between a Metal Shell and Metal Liner May Explain the High Rate of Failure of R3 Modular Metal-on-Metal Hips.

BACKGROUND: The R3 acetabular system used with its metal liner has higher revision rates when compared to its ceramic and polyethylene liner. In June 2012, the medical and healthcare products regulatory agency issued an alert regarding the metal liner of the R3 acetabular system. METHODS: Six retrieved R3 acetabular systems with metal liners underwent detailed visual analysis using macroscopic and microscopic techniques. RESULTS: Visual analysis discovered corrosion on the backside of the metal liners. There was a distinct border to the areas of corrosion that conformed to antirotation tab insertions on the inner surface of the acetabular shell, which are for the polyethylene liner. Scanning electron microscopy indicated evidence of crevice corrosion, and energy-dispersive X-ray analysis confirmed corrosion debris rich in titanium. CONCLUSION: The high failure rate of the metal liner option of the R3 acetabular system may be attributed to corrosion on the backside of the liner which appear to result from geometry and design characteristics of the acetabular shell.

Clinical Cold Welding of the Modular Total Hip Arthroplasty Prosthesis.

BACKGROUND: A head that is "clinically cold welded" to a stem is one of the commonest reasons for unplanned removal of the stem. It is not clear which hip designs are at greatest risk of clinical cold welding. METHODS: This was a case-control study of consecutively received hip implant retrievals; we chose the design of hip that had the greatest number of truly cold-welded heads (n = 11). For our controls, we chose retrieved hips of the same design but without cold welding of the head (n = 35). We compared the clinical variables between these 2 groups using nonparametric Mann-Whitney tests to investigate the significance of differences between the cold-welded and non-cold-welded groups. RESULTS: The design that most commonly caused cold welding was a combination of a Ti stem and Ti taper: 11 out of 48 (23%) were truly cold welded. Comparison of the clinical data showed that no individual factor could be used to predict this preoperatively with none of the 4 predictors tested showing any significance: (1) time to revision (P = .687), (2) head size (P = .067), (3) patient age at primary (P = .380), and (4) gender (P = .054). CONCLUSION: We have shown that clinical cold welding is most prevalent in Ti-Ti combinations of the stem and taper; approximately 25% of cases received at our center were cold welded. Analysis of clinical variables showed that it is not possible to predict which will be cold welded preoperatively. Surgeons should be aware of this potential complication when revising a Ti-Ti stem/head junction.

Augmentation and repair of tendons using demineralised cortical bone.

BACKGROUND: In severe injuries with loss of tendon substance a tendon graft or a synthetic substitute is usually used to restore functional length. This is usually associated with donor site morbidity, host tissue reactions and lack of remodelling of the synthetic substitutes, which may result in suboptimal outcome. A biocompatible graft with mechanical and structural properties that replicate those of normal tendon and ligament has so far not been identified. The use of demineralised bone for tendon reattachment onto bone has been shown to be effective in promoting the regeneration of a normal enthesis. Because of its properties, we proposed that Demineralised Cortical Bone (DCB) could be used in repair of a large tendon defect. METHODS: Allogenic DCB grafts in strip form were prepared from sheep cortical bone by acid decalcification and used to replace the enthesis and distal 1 cm of the ovine patellar tendon adjacent to the tibial tuberosity. In 6 animals the DCB strip was used to bridge the gap between the resected end of the tendon and was attached with bone anchors. Force plate analysis was done for each animal preoperatively and at weeks 3, 9, and 12 post operatively. At week 12, after euthanasia x-rays were taken and range of movements were recorded for hind limbs of each animal. Patella, patellar tendon - DCB and proximal tibia were harvested as a block and pQCT scan was done prior to histological analysis. RESULTS: Over time functional weight bearing significantly increased from 44% at 3 weeks post surgery to 79% at week 12. On retrieval none of the specimens showed any evidence of ossification of the DCB. Histological analysis proved formation of neo-enthesis with presence of fibrocartilage and mineralised fibrocartilage in all the specimens. DCB grafts contained host cells and showed evidence of vascularisation. Remodelling of the collagen leading to ligamentisation of the DCB was proved by the presence of crimp in the DCB graft on polarized microscopy. CONCLUSION: Combined with the appropriate surgical techniques, DCB can be used to achieve early mobilization and regeneration of a tendon defect which may be applicable to the repair of chronic rotator cuff injury in humans.

An In Vitro Comparison of the Primary Stability of 2 Tapered Fluted Femoral Stem Designs.

BACKGROUND: Proximal bony deficiencies present a biomechanical challenge to achieving primary stability in revision hip arthroplasty. Long tapered fluted stems have been engineered to span these defects but concerns of early subsidence are well documented. This work aimed primarily to investigate the issue of subsidence with this design using a cadaveric model. A secondary aim was to compare the stability of 2 versions of this design. METHODS: Seven pairs of cadaveric femora were obtained, dual emission x-ray absorpitometry scanned, with calibration radiographs taken for digital templating. Each bone was potted according to the ISO standard for fatigue testing and a Paprosky type 3 defect was simulated. The established cone-conical Restoration Modular (Stryker) system and a novel design with a chamfered tip and flute configuration (Redapt, Smith & Nephew) were examined. Movement at the stem-bone interface was measured using radiostereometric analysis and micromotion transducers. RESULTS: All restoration stems and 85% of the Redapt stems achieved stability by recognized criteria, micromotion < 150 µm and migration less than 2 mm. A Fisher exact test comparing the proportion of stems which were stable or unstable was not significant, P = .055. Mean axial subsidence (SD) was 0.17 mm (0.32) and 0.1 mm (0.131) for the Restoration and Redapt stems respectively. CONCLUSION: This study has demonstrated minimal subsidence in the immediate post-operative period using tapered fluted stems. Both designs achieved excellent stability despite simulation of Paprosky type 3 bony defects in the cadaveric model. This geometry appears satisfactory for use in revision surgery in the presence of significant proximal bony deficiencies.

The Relationship Between Cobalt/Chromium Ratios and the High Prevalence of Head-Stem Junction Corrosion in Metal-on-Metal Total Hip Arthroplasty.

BACKGROUND: The size of the clinical impact of corrosion of the taper junction of metal-on-metal total hip arthroplasties (MOM-THAs) is unclear. Examination of a large number of retrieved MOM resurfacings and total hip arthroplasties can help us understand the role of taper corrosion in metal ion release. METHODS: We graded the severity of corrosion at the taper junction of 395 MOM-THAs and compared the prerevision whole blood metal ion levels of these hips with 529 failed MOM hip resurfacings. RESULTS: Virtually all MOM-THA hips (n = 388) had evidence of corrosion of the head-stem taper junction and graded as severe in 31% (n = 124). The median cobalt/chromium (Co/Cr) ratio was 1.58 (0.01-13.82) and 1.08 (0-4.86) for MOM-THA and MOM hip resurfacing, respectively; this difference was significant (P < .001). THA hips with severely corroded tapers had the highest median Co/Cr ratio of 1.86 (0.01-10). CONCLUSIONS: This study demonstrates the high prevalence of severe taper corrosion, which may be related to an elevated Co/Cr ratio before revision.

Hydroxyapatite-coated collars reduce radiolucent line progression in cemented distal femoral bone tumor implants.

BACKGROUND: Aseptic loosening of massive bone tumor implants is a major cause of prosthesis failure. Evidence suggests that an osteointegrated hydroxyapatite (HA)-coated collar would reduce the incidence of aseptic loosening around the cemented intramedullary stem in distal femoral bone tumor prostheses. Because these implants often are used in young patients with a tumor, such treatment might extend the longevity of tumor implants. Questions/purposes We asked whether (1) HA-coated collars were more likely to osteointegrate; (2) HA collars were associated with fewer progressive radiolucent lines around the stem-cement interface; and (3) HA-coated collars were associated with less bone loss at the bone-shoulder implant junction? METHODS: Twenty-two patients were pair-matched to one of two groups--either (1) implants with a HA-coated ingrowth collar (HA Collar Group); or (2) implants without an ingrowth collar (Noncollar Group). Age, sex, and length of followup were similar in both groups. HA-coated collars were developed and used at our institution from 1992 to address the high failure rate attributable to aseptic loosening in patients with massive bone tumor implants. Before this, smooth titanium shafts were used routinely adjacent to bone at the transection site. The minimum followup was 2 years (mean, 7 years; range, 2-12 years). Radiographs obtained throughout the followup period were analyzed and osteointegration at the shaft of the implant quantified. Radiolucent line progression around the cemented stem was semi-quantitatively assessed and cortical bone loss at the bone-shoulder implant junction was measured during the followup period. RESULTS: Comparison of the most recent radiographs showed nine of 11 patients had osteointegrated HA collars, whereas only one patient in the Noncollar Group had osteointegration (p > 0.001). The radiolucent line score quantified around the cemented stem was lower in the HA Collar Group when compared with the Noncollar Group (p = 0.001). Results showed an increase in cortical bone loss at the bone-shoulder implant junction in the Noncollar Group when compared with the HA Collar Group (p < 0.001). CONCLUSIONS: Osteointegration at the implant collar resulted in fewer radiolucent lines adjacent to the intramedullary cemented stem and decreased cortical bone loss immediately adjacent to the transection site. These results suggest that the HA collar may help reduce the risk of aseptic loosening in patients with this type of implant, but longer followup and a larger prospective comparison series are necessary to prove this more definitively.

Stem cell engineered bone with calcium-phosphate coated porous titanium scaffold or silicon hydroxyapatite granules for revision total joint arthroplasty.

Aseptic loosening in total joint replacements (TJRs) is mainly caused by osteolysis which leads to a reduction of the bone stock necessary for implant fixation in revision TJRs. Our aim was to develop bone tissue-engineered constructs based on scaffolds of clinical relevance in revision TJRs to reconstitute the bone stock at revision operations by using a perfusion bioreactor system (PBRS). The hypothesis was that a PBRS will enhance mesenchymal stem cells (MSCs) proliferation and osteogenic differentiation and will provide an even distribution of MSCs throughout the scaffolds when compared to static cultures. A PBRS was designed and implemented. Scaffolds, silicon substituted hydroxyapatite granules and calcium-phosphate coated porous TiAl6V4 cylinders, were seeded with MSCs and cultured either in static conditions or in the PBRS at 0.75 mL/min. Statistically significant increased cell proliferation and alkaline phosphatase activity was found in samples cultured in the PBRS. Histology revealed a more even cell distribution in the perfused constructs. SEM showed that cells arranged in sheets. Long cytoplasmic processes attached the cells to the scaffolds. We conclude that a novel tissue engineering approach to address the issue of poor bone stock at revision operations is feasible by using a PBRS.

Comparison of mesenchymal stem cell proliferation and differentiation between biomimetic and electrochemical coatings on different topographic surfaces.

The hypothesis for this study was that there is no difference in mesenchymal stem cells (MSCs) proliferation and osteogenic differentiation between calcium-phosphate (CaP) coatings with different crystal size deposited on different topographic surfaces of metal discs. Polished (P) and sand-blasted (SB) tantalum and TiAl6V4 discs were CaP coated by three methods-biomimetic (BioM), electrochemical at 20 mA/cm(2) and at 6.5 mA/cm(2)-and cultured with MSCs. At days 4, 7 and 14, cell proliferation-alamarBlue(®) activity and DNA quantification-and differentiation down the osteogenic lineage-ALP activity normalised per amount of DNA and SEM (morphology)-were analysed. Results showed that MSCs proliferated more when cultured on the nano-sized BioM coatings compared to uncoated and electrochemically coated discs. MSCs also proliferated more on P surfaces than on SB and or electrochemical coatings. All the coatings induced osteogenic differentiation, which was greater on electrochemical coatings and SB discs.

Mechanical stability of a locked step-plate versus single compression screw fixation for medial displacement calcaneal osteotomy.

BACKGROUND: Reconstruction of a flatfoot commonly involves a calcaneal Medial Displacement Osteotomy (MDO) to correct hindfoot valgus in combination with soft tissue procedures. We compared fixation of an MDO using either a single, large cannulated screw versus a locking step-plate in load to failure in a cadaveric model. METHODS: Eight matched pairs of cadaveric limbs were loaded using a mechanical testing rig. Two pairs served as non-operated controls. The remaining paired limbs underwent a 10-mm MDO stabilized either with a single 7-mm screw or a step-plate with four locking screws. One pair was used as a pilot study and the remaining five pairs were loaded up to 4500 N to failure. RESULTS: In the five pairs loaded to failure, the median (with 95% CI) maximum force were 1779 N (1099-2312) and 826 N (288-1607) for the plate and screw, respectively (p = 0.043). With single screw fixation, the tuberosity fragment consistently failed by rotation and angulation into varus. With plate fixation, failure occurred as the screws cut through the internal surfaces of the tuberosity and body with no failure at the screw-plate interface. CONCLUSION: In this cadaveric model, a locked step-plate supported a significantly higher maximum force than a single large cannulated screw. CLINICAL RELEVANCE: The magnitude of the load supported by the locking step-plate suggests that allowing early weightbearing post-operation may be safe in clinical practice before union of the osteotomy.

Proximal ulna endoprosthetic replacement for bone tumours in young patients.

PURPOSE: The optimal reconstructive method after resection of malignant bone tumours of the proximal ulna is unknown.We report the outcome of endoprosthetic replacement in a young patient population. METHODS: This was a retrospective review of four patients[three males and one female; mean age 17.5 (range 11­31)years] who underwent limb salvage with a proximal ulnar endoprosthetic replacement following excision of malignant bone tumour. Mean follow-up was 85 (range 14­194) months. RESULTS: All patients were alive at final follow-up and reported an improvement in pain. One patient required transhumeral amputation for intralesional excision complicating a local recurrence at one month. Two patients developed fixed flexion deformities of the elbow, one of whom required radial-head excision. Mean Musculoskeletal Tumour Society (MSTS)score and Toronto Extremity Salvage Score (TESS) were 27(range 25­28) and 81 (73­88), respectively. CONCLUSIONS: Custom-made proximal ulna endoprosthetic replacement following resection of malignant bone tumours in young patients provides a stable reconstruction option with satisfactory function and without apparent compromise in patient survival.

The use of a novel "conservative hip replacement" to reconstruct an osteoarthritic hip with an occluded femoral canal.

This case report describes the successful use of a novel "conservative hip replacement" in conditions precluding the use of a standard total hip arthroplasty in a 70-year-old man. The femoral canal was occluded because of previous surgery for a bone tumor in the subtrochanteric region. The patient continues to do well at 4 years with minimal discomfort. At this interval, the Oxford Hip Score was 35. This conservative hip replacement has been developed to preserve bone stock and produce more physiologic loading of the proximal femur. Its design has been produced, using plain radiographs and computed tomography, to maximize "fit and fill" of the femur. The neck supports standard modular heads, allowing the use of any bearing surface. The prosthesis has been rigorously laboratory tested.

Intraosseous transcutaneous amputation prosthesis (ITAP) for limb salvage in 4 dogs.

OBJECTIVE: To report clinical application of intraosseous transcutaneous amputation prosthesis (ITAP) for limb salvage. STUDY DESIGN: Retrospective case series. SAMPLE POPULATION: Client owned dogs with malignant neoplasia of the distal aspect of the limb. METHOD: Distal limb amputation allowed press-fit insertion of the ITAP into the radius (n = 3) or tibia (1). Remaining soft tissues including skin were attached directly to the ITAP. Limb stump and ITAP were protected by bandaging (1) or external skeletal fixation (3) for 5-6 weeks before exoprosthesis attachment. Measures of outcome included subjective assessments of limb function by owners and veterinarians, radiographic (4) and histologic (1) examination. RESULTS: Dermal integration with the ITAP was achieved by 3 weeks and dogs were walking in a pain-free manner by 8 weeks. One dog was administered adjunctive carboplatin chemotherapy. No evidence of local tumor recurrence occurred. In 1 dog, ITAP fracture occurred at 10 weeks and was successfully managed by ITAP replacement. Three dogs were euthanatized because of confirmed or assumed metastatic disease at 8, 12, and 17 months. Histologic examination of the ITAP-limb interface at 1 year documented osseous and dermal integration. CONCLUSION: Implantation of ITAP to the distal limb of dogs is feasible and can result in favorable functional outcomes. Biological integration of osseous and dermal tissues with ITAP is reliable and robust.

Osteointegration of hydroxyapatite-coated collars in cemented massive endoprostheses following revision surgery.

AIMS: Hydroxyapatite (HA)-coated collars have been shown to reduce aseptic loosening of massive endoprostheses following primary surgery. Limited information exists about their effectiveness in revision surgery. The aim of this study was to radiologically assess osteointegration to HA-coated collars of cemented massive endoprostheses following revision surgery. METHODS: Retrospective review of osseointegration frequency, pattern, and timing to a specific HA-coated collar on massive endoprostheses used in revision surgery at our tertiary referral centre between 2010 to 2017 was undertaken. Osseointegration was radiologically classified on cases with a minimum follow-up of six months. RESULTS: In all, 39 patients underwent radiological review at mean 43.5 months; 22/39 (56.4%) showed no osseointegration to the collar. Revision endoprostheses for aseptic loosening were less likely to show osseointegration compared with other indications for revision. Oncological cases with previous or current infection were more likely to show osseointegration to ≥ 1 collar side than those without evidence of prior infection. CONCLUSION: This seven-year review identified osseointegration of HA-coated collars after revision surgery is less likely (43.6%, 17/39) than after primary surgery. Young patients who undergo revision surgery following initial oncological indication may benefit the most from this collar design. Use in revision oncological cases with a history of infection may be beneficial. HA-coated collars showed limited benefit for patients undergoing revision for failed arthroplasty with history of infection. Cite this article: Bone Jt Open 2021;2(6):371-379.

Pro-angiogenic and osteogenic composite scaffolds of fibrin, alginate and calcium phosphate for bone tissue engineering.

Due to the limitations of bone autografts, we aimed to develop new composite biomaterials with pro-angiogenic and osteogenic properties to be used as scaffolds in bone tissue engineering applications. We used a porous, cross-linked and slowly biodegradable fibrin/alginate scaffold originally developed in our laboratory for wound healing, throughout which deposits of calcium phosphate (CaP) were evenly incorporated using an established biomimetic method. Material characterisation revealed the porous nature and confirmed the deposition of CaP precursor phases throughout the scaffolds. MC3T3-E1 cells adhered to the scaffolds, proliferated, migrated and differentiated down the osteogenic pathway during the culture period. Chick chorioallantoic membrane (CAM) assay results showed that the scaffolds were pro-angiogenic and biocompatible. The work presented here gave useful insights into the potential of these pro-angiogenic and osteogenic scaffolds for bone tissue engineering and merits further research in a pre-clinical model prior to its clinical translation.

Partial Bone Formation in Additive Manufactured Porous Implants Reduces Predicted Stress and Danger of Fatigue Failure.

New porous implant designs made possible by additive manufacturing allow for increased osseointegration, potentially improving implant performance and longevity for patients that require massive bone implants. The aim of this study was to evaluate how implantation and the strain distribution in the implant affect the pattern of bone ingrowth and how changes in tissue density within the pores alter the stresses in implants. The hypothesis was that porous metal implants are susceptible to fatigue failure, and that this reduces as osteointegration occurs. A phenomenological, finite element analysis (FEA) bone remodelling model was used to predict partial bone formation for two porous (pore sizes of 700 µm and 1500 µm), laser sintered Ti6Al4V implants in an ovine condylar defect model, and was compared and verified against in vivo, histology results. The FEA models predicted partial bone formation within the porous implants, but over-estimated the amount of bone-surface area compared to histology results. The stress and strain in the implant and adjacent tissues were assessed before, during bone remodelling, and at equilibrium. Results showed that partial bone formation improves the stress distribution locally by reducing stress concentrations for both pore sizes, by at least 20%. This improves the long-term fatigue resistance for the larger pore implant, as excessively high stress is reduced to safer levels (86% of fatigue strength) as bone forms. The stress distribution only changed slightly in regions without bone growth. As the extent of bone formation into extensively porous bone implants depends on the level of stress shielding, the design of the implant and stiffness have significant influence on bone integration and need to be considered carefully to ensure the safety of implants with substantial porous regions. To our knowledge this is the first time that the effect of bone formation on stress distribution within a porous implant has been described and characterised.

The effect of strontium and silicon substituted hydroxyapatite electrochemical coatings on bone ingrowth and osseointegration of selective laser sintered porous metal implants.

Additive manufactured, porous bone implants have the potential to improve osseointegration and reduce failure rates of orthopaedic devices. Substantially porous implants are increasingly used in a number of orthopaedic applications. HA plasma spraying-a line of sight process-cannot coat the inner surfaces of substantially porous structures, whereas electrochemical deposition of calcium phosphate can fully coat the inner surfaces of porous implants for improved bioactivity, but the osseous response of different types of hydroxyapatite (HA) coatings with ionic substitutions has not been evaluated for implants in the same in vivo model. In this study, laser sintered Ti6Al4V implants with pore sizes of Ø 700 µm and Ø 1500 µm were electrochemically coated with HA, silicon-substituted HA (SiHA), and strontium-substituted HA (SrHA), and implanted in ovine femoral condylar defects. Implants were retrieved after 6 weeks and histological and histomorphometric evaluation were compared to electrochemically coated implants with uncoated and HA plasma sprayed controls. The HA, SiHA and SrHA coatings had Ca:P, Ca:(P+Si) and (Ca+Sr):P ratios of 1.53, 1.14 and 1.32 respectively. Electrochemically coated implants significantly promoted bone attachment to the implant surfaces of the inner pores and displayed improved osseointegration compared to uncoated scaffolds for both pore sizes (p<0.001), whereas bone ingrowth was restricted to the surface for HA plasma coated or uncoated implants. Electrochemically coated HA implants achieved the highest osseointegration, followed by SrHA coated implants, and both coatings exhibited significantly more bone growth than plasma sprayed groups (p≤0.01 for all 4 cases). SiHA had significantly more osseointegration when compared against the uncoated control, but no significant difference compared with other coatings. There was no significant difference in ingrowth or osseointegration between pore sizes, and the bone-implant-contact was significantly higher in the electrochemical HA than in SiHA or SrHA. These results suggest that osseointegration is insensitive to pore size, whereas surface modification through the presence of an osteoconductive coating plays an important role in improving osseointegration, which may be critically important for extensively porous implants.