Extensor mechanism and abductor reconstructions in total joint arthroplasty are problematic. Growing tendon into a metallic implant would have great reconstructive advantages. With the introduction of porous metal implants, it was hoped that tendons could be directly attached to implants. However, the effects of the porous metal structure on tissue growth and pore penetration is unknown. In this rat model, we investigated the effect of pore size on tendon repair fixation using printed titanium implants with differing pore sizes. There were four groups of six Sprague Dawley rats (n = 28) plus control (n=4).
Introduction and Objective. In the elderly population, chronic rotator cuff tears are often associated with high re-rupture rates after surgical tendon refixation. Implant materials, especially in combination with additives are supposed to positively influence healing outcome. Furthermore, adequate mechanical properties are crucial. In order to realize degradable implants with high specific surface area, polycaprolactone (PCL) was chosen as basic material and processed by electrospinning to achieve a high surface area for growth factor implementation and subsequent cell attachment. Materials and Methods. PCL (M. n. approx. 80,000 g/mol) was used to generate fibre mats by electrospinning (relative collector velocity 8 m/s; flow rate of 4 ml/h). Mechanical analysis was performed according to EN ISO 527–2:2012 with test specimen 1BA (5 mm in diameter). Maximum force at failure (Fmax) as well as stiffness were evaluated. For preclinical in vivo testing, a coating with CS-g-PCL was performed to increase cellular adhesion and biological integration. Native and TGF-ß3 loaded mats were examined in a chronic rat tendon defect model with dissection of the M. infraspinatus, four week latency and following refixation at the humerus with different PCL-fibre mats (approval Nr. 33.12–42502–04–15/2015). After 8 weeks, rats were finalized and tendon-bone insertions were analyzed biomechanically and via histological methods. Results. Electrospun PCL-fibre mats (n = 6) showed maximum forces of 2.19 ± 0.8 N and a stiffness of 0.38 ± 0.12 N/mm. Native rat infraspinatus tendons showed Fmax values of 28.4 ± 7.2 N and a stiffness of 11.8 ± 4.9 N/mm. After implantation, Fmax of the implant-tendon-regenerate was significantly lower in CS-g-PCL - fibre mat groups compared to native control tendons (mean 52 % of native tendon value). Functionalization with TGF-ß3 led to increased Fmax (78 % of the native tendon value). However, differences were not statistically significant. Histological evaluation revealed no differences between non loaded and TGF-ß3 loaded mats. The implants were strongly disintegrated. Granulation tissue and a high number of foreign body giant cells were present. Conclusions. Although mechanical properties of fabricated mats were low, loading of the fibre mats influenced the biomechanical outcome of refixed tendons, presumably due to their high potential for binding biological active substances like TGF-ß3. However, in ongoing studies these cell reactions, especially regarding polarization of macrophages and foreign body cells need to be characterized. This research project has been supported by the German Research Foundation “Graded
Customised individually made implants(CIM) total knee arthroplasty(TKA) are custom-made to better fit patients native anatomy and aim to improve outcomes which can be variable with conventional off-the-shelf(OTS). A systematic review and meta-analysis was conducted searching the MEDLINE and Embase databases. Studies reporting on patient reported outcome measures, clinical or radiological outcomes were included. 23 studies satisfied the search criteria (case-control studies14, case series8, cross-sectional studies1). There were 2,856(CIM) and 1,877(OTS) implants. The overall revision-rate was higher in CIM 5.9%vs3.7%OTS [OR 1.46(95% CI 0.82–2.62)]. MUA was higher in the CIM group 2.2%vs.1.1%OTS [OR 2.95(95% CI 0.95–9.13)] and overall complications rate was also higher in the CIM group 5% vs. 4.5%OTS [OR 1.45(95% CI 0.53–3.96)]. LOS was significantly shorter in the CIM group 2.9 days vs. 3.5 days [MD −0.51(95% CI −0.82–0.20)]. Pooled analysis for KSS showed no difference between CIM and OTS groups(Knee=90.5 vs. 90.6 [MD-0.27,(95% CI −4.27–3.73)] and Function=86.1 vs. 90.6[MD 1.51 (95% CI −3.69–6.70)] component of the scores. There was no significant difference in post-operative ROM between CIM and OTS groups 117.3° vs. 115.0° [MD 0.02,(95% CI −1.70–1.74)]. CIM TKAs has theoretical benefits over OTS TKAs however in this review they were associated with higher complication, MUA and revision rates with no difference in outcome scores and no improvement in target alignment. The findings of this review does not support the use of CIM over OTS prosthesis in total knee arthroplasty.Abstract
Title. Longitudinal Intravital Imaging to Quantify the “Race for the Surface” Between Host Immune Cell and Bacteria for Orthopaedic
Bioabsorbable metals hold a lot of potential as orthopaedic implant materials. Three metal families are currently being investigated: iron (Fe), magnesium (Mg) and zinc (Zn). Currently, however, biodegradation of such implants is poorly predictable. We thus used Direct Metal Printing to additively manufacture porous implants of a standardized bone-mimetic design and evaluated their mechanical properties and degradation behaviour, respectively, under in vivo-like conditions. Atomized powder was manufactured to porous implants of repetitive diamond unit cells, using a ProX DMP 320 (Layerwise, Belgium) or a custom-modified ReaLizer SLM50 metal printer. Degradation behaviour was characterized under static and dynamic conditions in a custom-built bioreactor system (37ºC, 5% CO. 2. and 20% O. 2. ) for up of 28 days.
A recent French report suggested that cobalt metal ions released from total hip replacements (THRs) were associated with an increased risk of dilated cardiomyopathy and heart failure. If the association is causal the consequences would be significant given the millions of Orthopaedic procedures in which cobalt-chrome is used annually. We examined whether cobalt-chrome containing THRs were associated with an increased risk of all-cause mortality, heart failure, cancer, and neurodegenerative disorders. Data from the National Joint Registry was linked to NHS English hospital inpatient episodes for 375,067 primary THRs with up to 14·5 years follow-up.
Metal-on-Metal (MoM) bearing surfaces were historically used for young patients undergoing total hip arthroplasty, and remain commonplace in modern hip resurfacing. In theory, it has been postulated that metal ions released from such implants may cross the placental barrier and cause harm to the fetus. In light of this potential risk, recommendations against the use of MoM components in women of child-bearing age have been advocated. The purpose of this systematic review was to evaluate: 1) the Metal-on-Metal bearing types and ion levels found; 2) the concentrations of metals in maternal circulation and the umbilical cord; and 3) the presence of abnormalities in the fetus A comprehensive literature review was conducted of studies published between January 1st, 1975 and April 1st, 2019 using specific keywords. (Introduction
Methods
BACKGROUND. Total hip revision surgery in cases with previous multiple reconstructive procedures is a challenging treatment due to difficulties in treatment huge bone defects with standard revision prosthetic combinations. A new specially made production system in Electron-Beam Melting (EBM) technology based on a precise analysis of patients' preoperative CT scans has been developed. METHODS. Objectives of design customization in difficult cases are to correctly evaluate patient's anatomy, to plan a surgical procedure and to obtain an optimal fixation to a poor bone stock. The 3D Printing (EBM) technology permits to create an extremely flexible patient matching implant and instrument, with material performances not viable with standard manufacturing process. Dedicated visual 3D tools and instrumentations improve implants congruency according to preoperative plan. Primary stability is enhanced and tailored on patient's anatomy by means of press-fit, iliac stems and the high friction performances of Trabecular Titanium matrix. The use of bone screws and their position is designed to enhance primary stability, even in critical bone conditions, avoiding implant stress shielding and allowing bone integration. 4 cases (2 men and 2 women) of acetabular customized implants were performed. Mean age at surgery was 51.5 years (range 25–72). Patients were reviewed clinically and radiographically at follow-up. RESULTS. No signs of miss-match between intraoperative bone conditions and pre-operative planning were observed. No additional bone grafts or further native bone removal were needed. Biomechanical parameters were restored by using internal modularity (i.e. face-changers / angled spacers). Face-changers allow to correct coverage and anteversion of the acetabular system. Incompatibility or impingement between the stems and new acetabular component was not observed and stem revision was performed in one case. On-table stability proved excellent and no intraoperative complications were observed. All patients underwent an immediate mobilization with full weight-bearing. Mean Harris Hip Score increased significantly from 13.9 (range 6.9–20.6) preoperatively to 75.8 (range 53.9–94) at last follow-up (mean 17.5, range: 10–33), showing an improvement in terms of both pain relief, function and joint mobility. Radiographically neither signs of instability, migration nor tilting were observed. No case of dislocation nor infection were recorded. CONCLUSION. A detailed anatomical reconstruction, in-depth preoperative planning, custom-implant design, high performance of the 3D-printing technology, system modularity and patient-specific surgical tools permitted an effective restoration of the biomechanical joint parameters in these complex revision cases. The optimal primary stability of the implants promoted an early osseointegration with the remaining bone stock. Further studies shall be necessary to assess the performance of these
Infections in spine surgery are relatively common and devastating complications, a significant burden to the patient and the healthcare system. Usually, the treatment of SSIs consists of aggressive and prolonged antibiotic therapy, multiple debridements, and in chronic cases, hardware removal. Infections are correlated with worse subjective outcomes and even higher mortality. Depending on the type of spine surgery, the infection rate has been reported to be as higher as 20%. Recently silver-coated implants have been introduced in spine surgery to reduce the incidence of post-operative infections and to improve implant survivorship. The aim of the present study is to evaluate complications and outcomes in patients treated with silver-coated implants because of spine infection. All consecutive patients who had spine stabilization with a silver-coated implant from 2018 to 2021 were screened for inclusion in the study. Inclusion criteria were: (1) six months of minimum follow-up; (2) previous surgical site infection; hematogenous spondylodiscitis requiring surgical stabilization. Demographic and surgical information were obtained via chart review, all the device-related complications and the reoperation rate were also reported. A total of 57 patients were included in the present study. The mean age was 63.4 years, and there were 36 (63%) males and 21 (37%) females. Among the included cases, 57% were SSIs, 33% were spondylodiscitis, and 9% were hardware mobilization. Comorbidities such as diabetes mellitus, obesity, smoke, and oncological history were significant risk factors. In addition, the organisms cultured were Staphylococcus species in most of the cases. At six months of follow-up, 40% of patients were considered free from infection, while 20% needed multiple surgeries. The present research showed satisfactory results of silver-coated implants for the treatment of spine infection.
Approximately 2,000 Skeletal transcutaneous osseointegration (STOI) procedures have been performed worldwide as of 2020, more than half of which have been performed by the Osseointegration Group of Australia using a press-fit technique with either ILP or OPL implant designs. Despite the consistently demonstrated clinical benefits, concerns regarding potential complications following STOI have slowed its widespread adoption. As more patients are followed for a longer period of time, longitudinal studies have confirmed complication rates are very acceptable, similar to those of total ankle and total elbow replacements. One of the major risk category is implant removal. The primary goal of this study was to investigate the complications and technical issues associated with transtibial osseointegration implant removal due to any cause. The focus here will be on the press-fit ILP and OPL implants, including the indications for removal and patient outcomes following removal. A review of our osseointegration registry between November 2010 and March 2022 was performed. Inclusion criteria were patients who have undergone removal of a transtibial osseointegration implant due to any cause. Selected patients either had a follow-up of at least two years or had their index osseointegration surgery at least two years prior to when the study was performed. Patients who have had osseointegration at other anatomic levels, and patients who underwent simultaneous total knee replacement with transtibial osseointegration were excluded from the registry search.Introduction
Materials & Methods
Infections are among the most diffused complications of the implantation of medical devices. In orthopedics, they pose severe societal and economic burden and interfere with the capability of the implants to integrate in the host bone, significantly increasing failure risk. Infection is particularly severe in the case of comorbidities and especially bone tumors, since oncologic patients are fragile, have higher infection rate and impaired osteoregenerative capabilities. For this reason, prevention of infection is to be preferred over treatment. This is even more important in the case of spine surgery, since spine is among the main site for tumor metastases and because incidence of post operative surgical-site infections is significant (up to 15-20%) and surgical options are limited by the need of avoiding damaging the spinal cord. Functionalization of the implant surfaces, so as to address infection and, possibly, co- adjuvate anti-tumor treatments, appears as a breakthrough innovation.
Unmet clinical needs in infection and tumors is presented, with a specific focus on the spine, then, new perspectives are highlighted for their treatment.
The Global Burden of Disease Study 2019 showed a 33.4% increase in fractures and a 65.3% increase in Years lived with disability (YLD) since 1990. Although the overall rate of fracture related infection (FRI) is low, it increases to 30% in complex fractures. In addition, the implantation of foreign materials, such as fracture stabilizing implants, decreases the number of bacteria needed to cause an infection. Then, when infections do occur, they are difficult to treat and often require multiple surgeries to heal. The bacteria can persist in the canaliculi of the bony tissue, in cells, in a biofilm on material or necrotic bone or in abscess communities. In the last decades, different approaches have been pursued to modify biomaterials as well as implant surface and to develop antimicrobial surfaces or local drug release strategies. This talk will give an introduction to the problem of bony and implant associated infections and presents the development and preclinical (as well as clinical) studies of two approaches for local drug delivery.
We have assessed the effect of a variety of implants commonly used in fracture fixation and joint replacement on the activation of metal detectors at airport security gates. A volunteer with metal implants strapped on and patients with implants in situ walked through the device.
3D printing acetabular cups offers the theoretical advantage of enhanced bony fixation due to greater design control of the porous implant surfaces. Analysing retrieved 3D printed implants can help determine whether this design intent has been achieved. We sectioned 14 off-the-shelf retrieved acetabular cups for histological analysis; 7 cups had been 3D printed and 7 had been conventionally manufactured. Some of the most commonly used contemporary designs were represented in both groups, which were removed due to either aseptic loosening, unexplained pain, infection or dislocation. Clinical data was collected for all implants, including their age, gender, and time to revision. Bone ingrowth was evaluated using microscopic assessment and two primary outcome measures: 1) bone area fraction and 2) extent of bone ingrowth. The additively manufactured cups were revised after a median (IQR) time of 24.9 months (20.5 to 45.6) from patients with a median (IQR) age of 61.1 years (48.4 to 71.9), while the conventional cups had a median (IQR) time to revision of 46.3 months (34.7 to 49.1, p = 0.366) and had been retrieved from patients with a median age of 66.0 years (56.9 to 68.9, p = 0.999). The additively and conventionally manufactured implants had a median (IQR) bone area fraction of 65.7% (36.4 to 90.6) and 33.9% (21.9 to 50.0), respectively (p < 0.001). A significantly greater amount of bone ingrowth was measured into the backside of the additively manufactured acetabular cups, compared to their conventional counterparts (p < 0.001). Bone occupied a median of 60.0% and 5.7% of the porous depth in the additively manufactured and conventional cups, respectively. 3D printed components were found to achieve a greater amount of bone ingrowth than their conventionally manufactured counterparts, suggesting that the complex porous structures generated through this manufacturing technique may encourage greater osteointegration.
Custom 3D printed implants can be anatomically designed to assist in complex surgery of the bony pelvis in both orthopaedic oncology and orthopaedic reconstruction surgery. This series includes patients who had major pelvic bone loss after initially presenting with tumours, fractures or infection after previous total hip arthroplasty. The extent of the bone loss in the pelvis was severe and therefore impossible to be reconstructed by conventional ‘off –the-shelve’ implants. The implant was designed considering the remaining bony structures of the contra-lateral hemi- pelvis, to provide an anatomical, secured support for the reconstructed hip joint. The latter was realised by strategically orientated screws and by porous structures (an integral part of the implant), which stimulates osseointegration. A custom pelvic implant was designed, manufactured and 3D printed. Reconstruction of the pelvis was performed together with a cemented (bipolar bearing) acetabular cup. In some cases, a proximal femoral replacement was also necessary to compensate for bony defects. All patients had sufficient range of motion (ROM) at the hip with post-operative stability. It has been verified, at six and twelve months postoperatively, that there is a strong hold of the implant due to osseointegration. Additionally, in patients whose posterior acetabular wall was missing, it was discovered that the implant assisted in bone formation and covered the entire posterior surface of the implant. All patients in this study managed with this novel treatment option, proved to have a stable pelvic reconstruction with restoration of leg lengths, improvement of strength and independent ambulation at short and medium term follow-up.
This study reports on minimum 2 year follow up outcomes on functional and quality of life of patients after undergoing bilateral osseointegration in comparison to traditional socket prosthesis. This is a prospective pilot study of 35 patients, consisting of 30 males and 5 females, aged 22–66 (mean 36) years at surgery, with minimum two-year follow-up. Selection criteria were age over 18 years, bilateral amputees who had socket-related problems or were wheelchair-bound with short stumps and non-reconstructable limb pathology. Principle outcome measures included the Questionnaire for persons with a Trans-Femoral Amputation (Q-TFA), Short Form Health Survey 36 (SF-36), Six Minute Walk Test (6MWT), Timed Up and Go (TUG), and K-levels. Adverse events were recorded including infection, revision surgery, fractures, and implant failures.Introduction
Materials & Methods
In this study, we examined the impact of dual-mobility (DM) versus fixed-bearing (FB) implants on outcomes following total hip arthroplasty (THA), a common and successful operation. We examined all-cause revision, revision due to dislocation, postoperative complications and functional scores in patients undergoing primary and revision THA. A systematic review was performed according to PRISMA guidelines, and was registered in PROSPERO (ID CRD42023403736). The Cochrane Library, Embase, MEDLINE, Web of Science, and Scopus were searched from inception to 12th March 2023. Eligible studies underwent meta-analysis and methodological assessment using the ROBINS-I tool. Data were pooled using a random-effects maximum-likelihood model. Eight comparative, non-randomised studies involving 2,810 DM implants and 3,188 FB implants were included. In primary THA, the difference in all-cause revision was imprecise (OR 0.82, 95% CI 0.25–2.72), whilst the DM cohort had a statistically significant benefit in revision due to dislocation (OR 0.08, 95% CI 0.02–0.28). In revision THA, the DM cohort showed significant benefit in all-cause revision (OR 0.57, 95% CI 0.31–1.05) and revision due to dislocation (OR 0.14, 95% CI 0.04–0.53). DM implants were associated with a lower incidence of implant dislocation and infection. Functional outcome analysis was limited due to underreporting. No intraprosthetic dislocations were observed. The results suggest that contemporary DM designs may be advantageous in reducing the risk of all-cause revision, revision due to dislocation, and postoperative complication incidence at mid-term follow-up. Further high-quality prospective studies are needed to evaluate the long-term performance of this design, especially in revision cases.
To evaluate the bacterial counts of sonicatied implants in patients with osteoarticular infections. Various studies have demostrated the usefulness of sonication of retrieved implants in order to provide an accurate microbiological diagnosis. Although cutoff values for original sonicate counts have been established, the use of centrifugation may influence these values A retrospective, single-center study, including sonication fluid samples from implants removed between January 2011 and October 2023, was performed. Patients were diagnosed with implant-associated infection based on the criteria available at the time of diagnosis. Osteoarticular implants were sonicated following the protocol described by Esteban et al. Sonicated fluid was centrifuged for 20 minutes at 3000 x g, and the sediment was resuspended in 5 mL of phosphate buffer solution. Ten µl of the sample were streaked onto each medium for quantitative culture. Bacterial counts exceeding 100,000 CFU/mL were considered as 100,000 CFU/mL for statistical analysis.Aim
Method
Majority of ultra-high molecular weight polyethylene (UHMWPE) medical devices used in total joint arthroplasty are crosslinked using gamma radiation to improve wear resistance. Alternative methods of crosslinking are urgently needed to replace gamma radiation due to rapid decline in its supply. Peroxide crosslinking is a candidate method with widespread industrial applications. Oxidative stability and biocompatibility, which are critical requirements for medical device applications, can be achieved using vitamin-E as an additive and by removing peroxide by-products through high temperature melting, respectively. We investigated compression molded UHMWPE/vitamin-E/di-cumyl peroxide blends followed by high-temperature melting in inert gas as a material candidate for tibial knee inserts. Wear resistance increased and mechanical properties remained largely unchanged. Oxidation induction time was higher than most of the other clinically available formulations. The material passed the local-end point biocompatibility tests per ISO 10993. Compounds found in exhaustive extraction were of no concern with margin-of-safety values well above the accepted level, indicating a desirable toxicological risk profile. Peroxide crosslinked, vitamin-E stabilized, and high temperature melted UHMWPE has recently been cleared for clinical use in tibial knee inserts. With all the salient characteristics needed in a material that can provide superior long-term performance in total joint patients, peroxide crosslinking can replace gamma radiation crosslinking of UHMWPE for use in all total joint replacement implant including acetabular liners.
3D Printed polyether-ether-ketone (PEEK) has gained widespread use in clinical practice due to its excellent biocompatibility, biomechanical compatibility, and personalization. However, pre-printed PEEK implants are not without their flaws, including bioinert, optimization distortion of 3D printing digital model and prosthetic mismatching. Recent advancements in mechanical processing technology have made it possible to print bone implants with PEEK fused deposition, allowing for the construction of mechanically adaptable implants. In this study, we aimed to synthesize silanized polycitrate (PCS) via thermal polymerization and in situ graft it to PEEK surface to construct an elastomer coating for 3D printed PEEK implants (PEEK-PCS). This incorporation of PCS allows the implant to exhibit adaptive space filling ability and stress dispersal. In vivo and in vitro results, PEEK-PCS exhibited exceptional osseointegration and osteogenesis properties along with macrophage M2 phenotypic polarization, inflammatory factors reducing, promotion of osteogenic differentiation in bone marrow mesenchymal stem cells (BMSCs). Additionally, PEEK-PCS displays good autofluorescence properties in vitro and in vivo, with stable fluorescence for 14 days, suggesting potential bioimaging applications. The study confirms that PEEK in situ grafting with thermo-polymerized PCS elastomers is a viable approach for creating multifunctional (bone defect adaptation, bioimaging, immune regulation, and osseointegration) implants for bone tissue engineering.