Recommendations of the OARSI FDA Osteoarthritis Devices Working Group

ArticleinOsteoarthritis and Cartilage 19(5):509-14 · March 2011with8 Reads
DOI: 10.1016/j.joca.2011.02.017 · Source: PubMed
Osteoarthritis (OA) is the most common type of arthritis and a major cause of chronic musculoskeletal pain and functional disability. While both pharmacologic and non-pharmacologic modalities are recommended in the management of OA, when patients with hip or knee OA do not obtain adequate pain relief and/or functional improvement, joint replacement surgery or other surgical interventions should be considered. Total joint arthroplasties are reliable and cost-effective treatments for patients with significant OA of the hip and knee. Evidence from cohort and observational studies has confirmed substantial improvements in pain relief with cumulative revision rates at 10 years following total hip (THA) and total knee arthroplasties (TKA) at 7% and 10%, respectively. Joint replacements have been used in most every synovial joint, although results for joints other than hip and knee replacement have not been as successful. The evolution of new device designs and surgical techniques highlights the need to better understand the risk to benefit ratio for different joint replacements and to identify the appropriate methodology for evaluating the efficacy and optimal outcomes of these new devices, designed to treat OA joints.
    • "Recently, a panel of experts, together with the US Food and Drug Administration described osteoarthritis (OA) as a complex, progressing and multiscale disease [1] affecting not only articular cartilage but also subchondral bone, ligaments, menisci, surrounding muscles and synovium. Structural deterioration of joint tissues leads to muscle atrophy, limb deformity and eventually loss of function [1, 2] . Understanding disease development and subsequent establishment of efficacious treatment strategies have been confounded by the inability to visualise the condition of the cartilage and quantitatively assess and monitor pathological changes. "
    [Show abstract] [Hide abstract] ABSTRACT: This work utilises advances in multi-tissue imaging, and incorporates new metrics which define in situ joint changes and individual tissue changes in osteoarthritis (OA). The aims are to (1) demonstrate a protocol for processing intact animal joints for microCT to visualise relevant joint, bone and cartilage structures for understanding OA in a preclinical rabbit model, and (2) introduce a comprehensive three-dimensional (3D) quantitative morphometric analysis (QMA), including an assessment of reproducibility. Sixteen rabbit joints with and without transection of the anterior cruciate ligament were scanned with microCT and contrast agents, and processed for histology. Semi-quantitative evaluation was performed on matching two-dimensional (2D) histology and microCT images. Subsequently, 3D QMA was performed; including measures of cartilage, subchondral cortical and epiphyseal bone, and novel tibio-femoral joint metrics. Reproducibility of the QMA was tested on seven additional joints. A significant correlation was observed in cartilage thickness from matching histology-microCT pairs. The lateral compartment of operated joints had larger joint space width, thicker femoral cartilage and reduced bone volume, while osteophytes could be detected quantitatively. Measures between the in situ tibia and femur indicated an altered loading scenario. High measurement reproducibility was observed for all new parameters; with ICC ranging from 0.754 to 0.998. In conclusion, this study provides a novel 3D QMA to quantify macro and micro tissue measures in the joint of a rabbit OA model. New metrics were established consisting of: an angle to quantitatively measure osteophytes (σ), an angle to indicate erosion between the lateral and medial femoral condyles (ρ), a vector defining altered angulation (λ, α, β, γ) and a twist angle (τ) measuring instability and tissue degeneration between the femur and tibia, a length measure of joint space width (JSW), and a slope and intercept (m, Χ) of joint contact to demonstrate altered loading with disease progression, as well as traditional bone and cartilage and histo-morphometry measures. We demonstrate correlation of microCT and histology, sensitive discrimination of OA change and robust reproducibility.
    Full-text · Article · Jan 2016
    • "Total hip replacement is a well established procedure for treatment of degenerative disorders of the hip (Goldberg et al., 2011) with high patient satisfaction (Mahomed et al., 2011). It is a cost effective surgical intervention (Räsänen et al., 2007) and potentially cost saving over the life of the patient (Chang et al., 1996). "
    [Show abstract] [Hide abstract] ABSTRACT: Thermal damage to host bone is a possible source of compromise of fixation in patients undergoing cemented total hip replacement (THR). Data on the subject to date are derived from mathematical modelling powered by animal studies. The aim of this study was to assess the effect of cement thickness on osteocyte viability in a population of patients undergoing cemented THR. An in vivo model was designed and validated by means of a finite element analysis. During standard hip joint replacement in 14 patients, the femoral necks were exposed before final resection to the heat of a curing cement mantle equivalent to 2.5 (Group 1) or 5 mm (Group 2) in vivo in the cemented acetabulum. Matched controls were collected for each patient. Osteocyte counts and viability were assessed by means of haematoxylin and eosin (H&E) stain and lactate dehydrogenase (LDH) assay. Ex vivo experiments were performed to determine the extent of thermal insult. H&E staining proved unreliable for assessing thermal insult in the short term. The LDH assay was reliable and demonstrated a significant reduction in osteocyte viability to a depth of 2.19 mm in group 1 and 9.19 mm in group 2. There was a significant difference between the groups at all depths. The ex vivo experiments revealed thermoclines indicating that host bone in the population undergoing cemented THR is more sensitive to the thermal insult delivered by curing polymethylmethacrylate cement than previously believed. This thermal insult may weaken the fixation between bone and cement and contribute towards aseptic loosening, the commonest cause of failure of THRs.
    Full-text · Article · Jan 2014
  • [Show abstract] [Hide abstract] ABSTRACT: Osteoarthritis (OA), with a high prevalence and economic impact, is a progressive diarthrodial joint disease that substantially reduces quality of life and is mainly characterized by degradation of the extracellular matrix (ECM) and the loss of a chondrogenic phenotype in articular cartilage. Strategic targeting of therapeutic genes to OA cartilage may offer potent alternatives for restoring the structure of the damaged cartilage. α2-macroglobulin (α2M), a member of the α2M family of proteins, prevents the degradation of the ECM by inhibiting the activity of a disintegrin-metalloproteinases with thrombospondin motifs (ADAMTSs) and matrix metalloproteinases (MMPs). Sox9, a key chondrogenic transcription factor, plays a crucial role in the development and maintenance of the chondrogenic phenotype. Therefore, modulation of the OA cartilage by genetically modifying the levels of α2M and Sox9 expression may be advantageous in ameliorating the course of OA. To acquire long-lasting expression of the α2M and Sox9 genes, gene transfer systems are required. The chitosan vector system is expected to be useful for direct gene therapy for joint disease. Thus, we conclude that co-expression of the α2M and Sox9 genes, combined with chitosan‑mediated gene delivery, will offer potential as a novel means by which to treat OA via intra-articular injection.
    Article · Apr 2012
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