Intra-articular injection of bone marrow aspirate concentrate (mesenchymal stem cells) in KL grade III and IV knee osteoarthritis: 4 year results of 37 knees.

Cell based therapies are increasingly used and results of bone marrow aspirate concentrate (BMAC) show encouraging short- to middle term results, superior to hyaluronic acid and platelet rich plasma (PRP). Most studies describe patients with mild to moderate arthritis and results of patients with KL III and IV osteoarthritis of the knee are limited to short term evaluations. Hence, the aim of this prospective study was to investigate the mid-term outcome of BMAC injections in patients with severe osteoarthritis of the knee. The BMAC was retrieved from the iliac crest as previously published with the "reorientation technique" from the iliac crest in supine position in analgosedation and injected into the patients' osteoarthritic knees. Patients were followed-up for 4 years. WOMAC, IKDC, SF 36 and walking distance were measured in a total of 37 participants. There was an improvement of IKDC and WOMAC from the first year onwards and a significant improvement beginning from year 2 up to the mid-term follow-up: IKDC increased significantly from 56 ± 12 (range 34-81) to 73 ± 13 (range 45-100), p < 0.001. WOMAC decreased significantly from 40 ± 23 (range 6-96) to 18 ± 18 (range 0-67), p < 0.001. 35 of 37 knees improved regarding IKDC and WOMAC score from the first to the last follow-up. Not a single protheses had to be implanted. Elaborate statistical analysis was done to exclude covariates and confounders (age, time, BMI,…). In summary, this is the first study on BMAC injections into 37 osteoarthritic knees with a 4-year follow up showing significant improvements in IKDC and WOMAC scores, and with a 95% success rate and significant improvement in walking distance.Clinical relevance Describes the 4-year outcome of BMAC injections for knees with severe osteoarthritis.

Reorientation technique has benefits in bone marrow aspiration of stem cells.

We treated patients with osteoarthritis of the knee using injections of bone marrow aspirate concentrate (stem cell therapy). Since multiple controversial harvesting methods using different sites, needles, volumes and techniques have been described, we aimed to compare those methods. Four different harvesting sites at the iliac crest, three different types of needles, three different types of volumes and two different harvesting techniques were compared in 48 bone marrow aspirations. The conventional technique (Group 1) was compared with a reorientation technique (Group 2). The number of leucocytes and CD34 + cells and the viability in bone marrow aspirate (BMA) were analysed with a CytoFLEX Flow Cytometer. The reorientation technique showed significantly higher cell counts than the conventional technique in all parameters. Leucocytes per nl increased from 5 ± 2 to 12 ± 4 (p < .001), and CD 34 + cells per µl increased from 40 ± 40 to 140 ± 98 (p = .003). There was no difference between anterior and posterior harvesting at the iliac crest or between use of a thick and use of a thin needle. Use of the reorientation technique, compared to employing the conventional technique, has a significant advantage since the number of leucocytes and CD34 + cells can be tripled. For the use of bone marrow aspirate in the case of arthritis, it might therefore be a future option to harvest a maximum cell yield through the new reorientation technique and to omit centrifugation. However, the clinical relevance of these findings remains the subject of future studies.Level of Evidence: Level I.Clinical relevance: Enhanced technique of BMA for knee surgeons to ensure the maximum cell yield for stem cell therapy in regenerative medicine.

Migration characteristics of the Corail hydroxyapatite-coated femoral stem-a retrospective clinical evaluation and migration measurement with EBRA.

PURPOSE: Uncemented stem migration analysis by EBRA-FCA (Einzel-Bild-Roentgen Analyse, Femoral Component Analysis) has been seen to be a good predictive indicator for early implant failure. In this study, we investigated the migration behavior of a cementless press-fit stem after two years follow-up. Stem type and postoperative gap between collar and femur were evaluated as a risk factor. METHODS: Applying a retrospective study design, we reviewed all consecutive patients who between 2013 and 2017 received a cementless press-fit Corail stem (DePuy Orthopaedics Inc., Warsaw, IN, USA) at our Department. We reviewed medical histories and performed radiological measurements using EBRA-FCA software. RESULTS: A total of 109 stems in 105 patients (female: 60; male: 45) fulfilled our inclusion criteria. Mean age at surgery was 67.8 (range, 21.6-90.5) years. EBRA migration analysis showed a mean subsidence of 1.8 mm (range, 0.0-12.1) at final follow-up. At 18 months mean subsidence of collared stems was significantly lower than in the collarless group [1.3 mm (range, 0.0-7.6) vs. 3.2 mm (range, 0.5-10.7), p = 0.0104]. Collared stems resting on the femoral cut presented a tendency to less subsidence than did collared stems showing a postoperative gap between collar and femur (1.3 vs. 2.0 mm) without finding statistical significance (p > 0.05). CONCLUSIONS: Low subsidence and the migration pattern of the cementless press-fit stem may predict a good long-term result. Collared stems investigated in our study provide good stability and are able to prevent significant subsidence. Trial registration number and date of registration: Number: 20181024-1875; Date: 2018-10-24.

Case Report: Autologous Bone Marrow Derived Intrathecal Stem Cell Transplant for Autistic Children - A Report of Four Cases and Literature Review.

Despite steadily growing numbers of children diagnosed with autism spectrum disorders (ASD), causative treatment is unavailable. Recently, biological cell therapies involving pluripotent cells have raised hopes towards sustained beneficial outcome. We herein report data of four children diagnosed with ASD, who were treated with autologous, bone marrow (BM)-derived, intrathecally and simultaneously intravenously applied, point-of-care stem cell transplant (SCT). The three boys and one girl received the diagnosis at ages between 2-4 years. The decision to perform the procedure was preceded by limited beneficiary impact of conventional symptom-based, psychological and pharmacological interventions. At ages of 4-14 years the children received their SCT, no immediate or late adverse events were reported. Disappearance of symptoms were observed by the parents during the following year and consequently improved Autism Treatment Evaluation Checklist (ATEC) scores were reported. The SCT procedure, in trained hands, can be a safe and promising treatment option in children with ASD, responding in a non-satisfactory manner to conventional treatments. It is postulated that SCT may, among others, assert its positive effect by counteracting a cerebral inflammatory autoimmune process which in turn supports the responsiveness to behavioral and pharmacological interventions. Our results in this small group are encouraging, but certainly need further investigation in larger cohorts.

Improved Injection Technique of Ethanol for Morton's Neuroma.

BACKGROUND: Morton's neuroma is a common cause of forefoot pain. Various conservative methods (injections of various pharmacologic agents) have been published with an outcome of 6%-75% success rate (free of pain in daily life) per injection. The aim of the present study was to assess the outcome of an improved localization technique, a higher dosage, and a higher percentage of ethanol. METHODS: Using fluoroscopic and electroneurographic guidance, 2.5 mL of 70% ethanol were injected into 33 feet with a magnetic resonance imaging (MRI)-verified neuroma. We evaluated patients at up to 5-year follow-up. RESULTS: A "success rate" of more than 82% per single injection (defined as free of pain in daily life) was achieved and no recurrence was seen over 5 years. All scores (visual analog scale; Short Form-36 subscales, American Orthopaedic Foot & Ankle Society ankle-hindfoot score) showed significant improvement (P < .0001). Mean 1.2 injections were necessary. No significant side effects were seen. However, some mild pain persisted in some patients who participated in sports. CONCLUSION: The injection of 2.5 mL of 70% ethanol under fluoroscopic and electroneurographic guidance was a safe method for the treatment of MRI-verified Morton's neuromas. Combining the effect of a higher percentage of alcohol and a higher dosage and an improved localization technique resulted in a high rate of patients without pain. LEVEL OF EVIDENCE: Level IV, cases series, prospective.

Projections of hip arthroplasty in OECD countries up to 2050.

OBJECTIVE: The study aims to estimate the future demand of hip arthroplasty for OECD countries and to compare the results with earlier studies. DESIGN: Based on data availability and validity 20 countries out of the OECD sample have been selected for projection analysis. Using historic data (1995-2012) and multiple linear regression technics a projection model was designed by an iterative process considering different explanatory variables such as health care expenditure, age groups, and projection time frames. RESULTS: The utilisation of hip implants in OECD countries continues to grow by a compound annual growth rate (CAGR) of 1.2%, leading to an increase from 1.8 million per year in 2015 to 2.8 (2.6-2.9) in the year 2050. The mean utilisation rate (incidence) of hip implants will increase from 184 (143-312) to 275 (174-457) per 100.000 total population in the same time. Australia, Ireland, Norway, Switzerland and other countries will face a significant increase of utilisation of hip implants between +95% and +120% from 2015 to 2050. CONCLUSIONS: Hip arthroplasty continues to rise significantly over the next 35 years. Therefore, some countries will face an exponential use of hip arthroplasty of additional 100% or more and thus challenges for their health care budgets. Revision burden will increase disproportionately. Thus, health technology assessment (HTA) for medical devices, longevity and quality control will become more relevant.

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

INTRODUCTION: Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. METHODS: A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. RESULTS: A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). CONCLUSIONS: Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

Quality of outcome data in total hip arthroplasty: comparison of registry data and worldwide non-registry studies from 5 decades.

PURPOSE: This systematic review assessed evidence on outcome (revision rate for all reasons) following hip arthroplasty from its beginning 5 decades ago. METHODS: We evaluated all studies from all current hip implants since their market introduction in 1962 regarding "revision rate per 100 observed component years". Data were compared with arthroplasty registries. RESULTS: A total of 54 different hip implants were included: for 81% (44 of 54) data is either absent or poor; for 30% (16 of 54) not a single publication could be found. For 52% (28 of 54) less than 100 revisions for all reasons are published in non-registry studies. The remaining 10 implants (19%) comprise 92638 primary implants with 4473 revisions. Control group were the same implants with 111658 primary cases and 3029 revisions from arthroplasty registries. A systematic developer bias as in knee arthroplasty could not be found but several independent authors were found to significantly bias the literature. The overall revision rates per 100 observed component years from non-registry studies (and joint registries) are 0.4 (0.5) for stems, 0.7 (0.7) for cups and 1.4 (2.1) for resurfacing systems. CONCLUSIONS: For 81% of all hip implants assessed limited evidence exists from non-registry studies regarding outcome (revision rate) even 5 decades after market introduction. For the remaining 19% of implants no systematic developer bias could be found but several individual authors significantly biased results of single implants. We therefore ask for a more active publication of new implants.

Quality of outcome data in knee arthroplasty.

BACKGROUND AND PURPOSE: Recent reports on developer bias in unicondylar knee arthroplasty led to concerns about quality of publications regarding knee implants. We therefore compared revision rates of registry and non-registry studies from the beginning of knee arthroplasty up to the present. We assessed the time interval between market introduction of an implant and emergence of reliable data in non-registry studies. MATERIAL AND METHODS: We systematically reviewed registry studies (n = 6) and non-registry studies (n = 241) on knee arthroplasty published in indexed, peer-reviewed international scientific journals. The main outcome measure was revision rate per 100 observed component years. RESULTS AND INTERPRETATION: For 82% of the 34 knee implants assessed, revision data from non-registry studies are either absent or poor. 91% of all studies were published in the second and third decade after market introduction. Only 5% of all studies and 1% of all revisions were published in the first decade. The first publications on revision rates of total knee arthroplasty (TKA) started 6 years after market introduction, and reliable data were found from year 12 onward in non-registry studies. However, in unicondylar knee arthroplasty (UKA) the first publications on revision rates could be found first 13 years after market introduction. Revision rates of TKA from non-registry studies were reliable after year 12 following market introduction. UKA revision rates remained below the threshold of registry indices, and failed to demonstrate adjustment towards registries. Thus, the superiority of registry data over non-registry data regarding outcome measurement was validated.

Migration of the Duraloc cup after 5 years.

The Duraloc cup is a frequently used metal-backed, porous-coated, hemispherical, press-fit acetabular component. Published data on loosening rates are contradictory. In this study we investigated migration patterns with computer-assisted Einzel-Bild-Roentgen-Analyse (EBRA) of 67 Duraloc 100 cups. Cup migration and clinical scores were analysed over a 5-year follow-up period. Median total migration of the Duraloc 100 cup was 1.21 mm at 5 years. Seventy-five percent of implants were radiologically stable at 2 years and 90% at 4 years. One cup loosened aseptically at 60 months, requiring revision. Cup diameters > or = 54 mm migrated significantly more than cups < 54 mm in diameter (p = 0.029 at 4 years). There was a significant correlation between high polyethylene wear and further migrating cups within the first post-operative year (p = 0.035 at 12 months). Our analysis revealed significantly higher wear in males (p = 0.029 at 4 years). Radiological loosening at two years could be calculated using receiver-operating characteristic curve analysis, and 1.2 mm as an adequate threshold value (sensitivity = 100%, specificity = 89%).