Introduction of innovations in joint arthroplasty: Recommendations from the 'EFORT implant and patient safety initiative'.

With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies.

Does Posterior Tibial Slope Influence Knee Kinematics in Medial Stabilized TKA?

Background: During total knee arthroplasty (TKA), one of the key alignment factors to pay attention to is the posterior tibial slope (PTS). The PTS clearly influences the kinematics of the knee joint but must be adapted to the coupling degree of the specific TKA design. So far, there is hardly any literature including clear recommendations for how surgeons should choose the PTS in a medial stabilized (MS) TKA.

Osteogenic Differentiation of Human Adipose-Derived Stem Cells Seeded on a Biomimetic Spongiosa-like Scaffold: Bone Morphogenetic Protein-2 Delivery by Overexpressing Fascia.

Human adipose-derived stem cells (hADSCs) have the capacity for osteogenic differentiation and, in combination with suitable biomaterials and growth factors, the regeneration of bone defects. In order to differentiate hADSCs into the osteogenic lineage, bone morphogenetic proteins (BMPs) have been proven to be highly effective, especially when expressed locally by route of gene transfer, providing a constant stimulus over an extended period of time. However, the creation of genetically modified hADSCs is laborious and time-consuming, which hinders clinical translation of the approach.

Experimental measurements of micromotions of the cementless intervertebral disc prostheses in the cadaver bone.

Background: Sufficient primary stability is mandatory for successful bony prosthetic incorporation. Therefore, defined micromotion values of 150 μm should not be exceeded as higher values might compromise the ingrowth of bone trabeculae to the implant surface. The aim of this study was to evaluate the primary stability of different cementless disc prosthesis in a cadaver model.

Biomechanical comparisons of three minimally invasive Achilles tendon percutaneous repair suture techniques.

Background: While no gold standard exists for the management of Achilles tendon ruptures, surgical repair is common in healthy and active patients. Minimally invasive repair methods have become increasingly popular, while biomechanical equivalency hasn't been proven yet.

Methods: A mid-substance Achilles tendon rupture was created 6 cm proximal to the calcaneal insertion in 27 fresh-frozen cadaveric ankles.

Functional results after oncological scapula resections.

Introduction: Tumors of the scapula are rare representing only 1.6%-2.8% of all skeletal tumor localizations.

The Expression Levels of Toll-like Receptors after Metallic Particle and Ion Exposition in the Synovium of a Murine Model.

To date, the exact role of specific Toll-like receptors (TLRs) in regulating immune reactivity to metallic byproducts of orthopedic implants has not been fully clarified. In light of the situation, our objective in this investigation was to assess the expression levels of surface TLRs after metallic particle and ion exposure in an established animal model. Ten female BALB/c mice in each group received intra-articular injections of phosphate buffer (PBS) (control), metallic particles (MP), and metallic ions (MI), respectively.

The results of health-related quality of life assessment depend on the prevailing rhythm at the assessment: Experience from the CAPTAF trial (Catheter Ablation Compared with Pharmacological Therapy for Atrial Fibrillation).

Aims: To assess whether the prevailing rhythm at the time of replying to symptom and health-related quality of life (HR-QoL) questionnaires impacts the findings.

Method: A total of 150 patients from the randomized Catheter Ablation Compared with Pharmacological Therapy for Atrial Fibrillation-trial, comparing atrial fibrillation (AF) ablation versus drugs, were included. The effect of the prevailing rhythm on the outcome results of the HR-QoL 36-Item Short-Form Health Survey, the symptom severity questionnaire (SSQ), and the European Heart Rhythm Association (EHRA) score for classification of AF-related symptoms was assessed.

Effects of a medical second opinion programme on patients' decision for or against knee arthroplasty and their satisfaction with the programme.

Background: German social legislation gives patients the right to obtain a second opinion before elective surgery and defines quality criteria for reimbursement by statutory health insurances. However, the effects of second opinions before elective surgery are largely unknown. The aim of this study was to evaluate the effects of a second opinion programme in patients recommended for knee arthroplasty.

Local and systemic inflammation after implantation of a novel iron based porous degradable bone replacement material in sheep model.

Despite the high potential of healthy bone to regenerate, the reconstruction of large bone defects remains a challenge. Due to the lack of mechanical stability of existing bone substitutes, recently developed degradable metallic alloys are an interesting alternative providing higher load-bearing capabilities. Degradable iron-based alloys therefore might be an attractive innovation.

Atrial fibrillation burden, episode duration and frequency in relation to quality of life in patients with implantable cardiac monitor.

Aims: To assess the relation between atrial fibrillation (AF) characteristics and health-related quality of life (QoL), and which AF characteristic had the greatest impact.

Method: The AF characteristics burden (percentage of time in AF), duration and number of AF episodes/month were obtained from implantable cardiac monitors during the 2-month run-in period in 150 patients included in the randomized CAPTAF trial comparing early ablation and antiarrhythmic drug therapy. The QoL was measured by the General Health and Vitality dimensions of the 36-Item Short-Form Health Survey.

Impact of femoro-tibial size combinations and TKA design on kinematics.

Introduction: The variability in patients' femoral and tibial anatomy requires to use different tibia component sizes with the same femoral component size. These size combinations are allowed by manufacturers, but the clinical impact remains unclear. Therefore, the goals of our study were to investigate whether combining different sizes has an impact on the kinematics for two well-established knee systems and to compare these systems' kinematics to the native kinematics.

Secondary Patellar Resurfacing in TKA: A Combined Analysis of Registry Data and Biomechanical Testing.

The German Arthroplasty registry (EPRD) has shown that different prosthesis systems have different rates of secondary patellar resurfacing: four years after implantation, the posterior-stabilized (PS) Vega prosthesis has a 3.2% risk of secondary patellar resurfacing compared to the cruciate-retaining (CR) Columbus prosthesis at 1.0% (both Aesculap AG, Tuttlingen, Germany).

Ceramic-on-Ceramic Bearing in Total Hip Arthroplasty Reduces the Risk for Revision for Periprosthetic Joint Infection Compared to Ceramic-on-Polyethylene: A Matched Analysis of 118,753 Cementless THA Based on the German Arthroplasty Registry.

Periprosthetic joint infection (PJI) is one of the most common complications in total hip arthroplasty (THA). The influence of bearing material on the risk of PJI remains unclear to date. This registry-based matched study investigates the role of bearing partners in primary cementless THA.

Relative Sensitivity of Core-Needle Biopsy and Incisional Biopsy in the Diagnosis of Musculoskeletal Sarcomas.

Background: There is no evidence as to the diagnostic value of the two most frequently used methods of biopsies in sarcomas: Incisional or core needle biopsy. The aim of our study was to evaluate the diagnostic sensitivity of the incisional and the core needle biopsy techniques in the diagnosis of bone and soft tissue sarcomas.

Methods: We included 417 patients with a definitive diagnosis of bone or soft tissue sarcoma in whom a total of 472 biopsies had been performed.

Short versus conventional stem in cementless total hip arthroplasty : An evidence-based approach with registry data of mid-term survival.

Background: Short-stemmed total hip arthroplasty (THA) is well established and gaining popularity in Germany. The perception that short stems may predispose to primary instability in the femur has resulted in a more thorough follow-up of younger patient cohorts than the typical uncemented THA population. To address this issue, an evidence-based approach is presented for a retrospective mid-term survival analysis of a large registry-based cohort in primary cementless THA comparing short stems with a matched group of conventional stems.

Osteoinduction within adipose tissue fragments by heterodimeric bone morphogenetic Proteins-2/6 and -2/7 versus homodimeric bone morphogenetic protein-2: Therapeutic implications for bone regeneration.

Background: Fragments of subcutaneous adipose tissue that have been genetically modified to express bone morphogenetic protein-2 (BMP-2) regenerate large segmental osseous lesions in rodents. Gene-activated adipose tissue can be implanted into osseous defects without prior cell extraction and cell culture. The present study aimed to explore whether the heterodimers BMP-2/6 or BMP-2/7 exceed the osteoinductive effect of BMP-2 on adipose tissue.

Desmoid Tumors of the Foot: A Retrospective Study of Four Patients.

Background: Desmoid-type fibromatosis (DF) is an aggressive (myo)fibroblastic neoplasm with an infiltrative growth pattern and a tendency for local recurrence. It is rarely seen at the foot. The aim of this retrospective study was to analyze clinical presentation, therapy, and outcomes in a consecutive series of four patients with DF at the foot.

Metaphyseal anchoring short stem hip arthroplasty provides a more physiological load transfer: a comparative finite element analysis study.

Background: Short stem total hip arthroplasty (SHA) preserves femoral bone stock and is supposed to provide a more natural load transfer compared to standard stem total hip arthroplasty (THA). As comparative biomechanical reference data are rare we used a finite element analysis (FEA) approach to compare cortical load transfer after implantations of a metaphyseal anchoring short and standard stem in native biomechanical femora.

Methods: The subject specific finite element models of biomechanical femora, one native and two with implanted metaphyseal anchoring SHA (Metha, B.

Primary bone lymphoma: Clinical presentation and therapeutic considerations.

Background: Primary lymphoma of bone (PBL) is a rare entity. Due to unspecific clinical signs and equivocal radiographs diagnosis may be delayed. This retrospective report of 109 PBL cases demonstrates typical aspects of the lesion.

[Realistic preclinical finite element simulation in knee and hip replacements].

Background: In the process of developing an implant, computer simulation involving finite element (FE) methods allows the early identification of design-related issues, thus reducing the development process to a minimum. In addition, the FE simulation is used for selecting testing combinations in order to provide the relevant authority with proof of a "worst-case" construct scenario for the subsequent experimental fatigue test.

Results: Research studies with FE simulations show that implant positioning may affect mechanical loads under certain circumstances and, therefore, influence the preclinical evaluation of the prostheses.

Ceramic Coating in Cemented Primary Total Knee Arthroplasty is Not Associated With Decreased Risk of Revision due to Early Prosthetic Joint Infection.

Background: Prosthetic joint infection (PJI) is one of the most frequent and devastating causes of short-term revision total knee arthroplasty (TKA). In vitro evidence suggests ceramic surfaces demonstrate resistance to biofilm, but the clinical effect of bearing surface modifications on the risk of PJI remains unclear. This premier registry-based study examines the influence of ceramic bearing surface coatings on the outcome in cemented primary TKA.

Influence of different anteversion alignments of a cementless hip stem on primary stability and strain distribution.

Background: Stem anteversion in total hip arthroplasty is well known to have a high impact on dislocation, but empirical data regarding the clinical and biomechanical influence is lacking. Therefore, we evaluated the impact of different anteversion alignments on the primary stability and strain distribution of a cementless stem.

Methods: The cementless CLS Spotorno stem was implanted in 3 different groups (each group n = 6, total n = 21) with different anteversion alignments: reference anteversion (8°), +15° torsion in anteversion (+23°), -15° torsion in retroversion (-7°) using composite femurs (Sawbones).

The Effect of Resection Margin on Local Recurrence and Survival in High Grade Soft Tissue Sarcoma of the Extremities: How Far Is Far Enough?

Background: The significance of surgical margins after resection of soft tissue sarcomas in respect to local-recurrence-free survival and overall survival is evaluated.

Methods: A total of 305 patients with deep-seated, G2/3 soft tissue sarcomas (STS) of the extremity, the trunk wall, or the pelvis were reviewed. The margin was defined according to the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) classification system (R0-2), the Union Internationale Contre le Cancer (UICC) classification (R + 1 mm) for which a margin <1 mm is included into the R1 group, and in groups of <1 mm, 1-5 mm, >5 mm, or >10 mm.