Recommendations of the OARSI FDA Osteoarthritis Devices Working Group. Osteoarthritis

Department of Orthopaedics, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Osteoarthritis and Cartilage (Impact Factor: 4.17). 03/2011; 19(5):509-14. 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.

5 Reads
  • Source
    • "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.
    European cells & materials 01/2014; 27:50-63. · 4.89 Impact Factor
  • [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.
    Molecular Medicine Reports 04/2012; 6(1):16-8. DOI:10.3892/mmr.2012.859 · 1.55 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Variance in pain after total knee and hip arthroplasty may be due to a number of procedural and peripheral factors but also, in some individuals, to aberrant central pain processing as is described in conditions like fibromyalgia. To test this hypothesis, the authors conducted a prospective, observational cohort study of patients undergoing lower-extremity joint arthroplasty. Five hundred nineteen patients were preoperatively phenotyped using validated self-reported pain questionnaires, psychological measures, and health information. In addition to being assessed for factors previously found to be associated with poor outcomes in arthroplasty, participants also completed the American College of Rheumatology survey criteria for fibromyalgia. Previous studies have suggested that rather than being "present" or "absent," features of fibromyalgia as measured by this instrument, occur over a wide continuum. Postoperative pain control was assessed by total postoperative opioid consumption. Preoperatively, patients with higher fibromyalgia survey scores were younger, more likely to be female, taking more opioids, reported higher pain severity, and had a more negative psychological profile. In the multivariate analysis, the fibromyalgia survey score, younger age, preoperative opioid use, knee (vs. hip), pain severity at baseline, and the anesthetic technique were all predictive of increased postoperative opioid consumption. The use of the survey criteria for fibromyalgia led to the finding of distinct phenotypic differences, and the measure was independently predictive of opioid consumption. This self-report measure may provide an additional simple means of predicting postoperative pain outcomes and analgesic requirements. Future studies are needed to determine whether tailored therapies can improve postoperative pain control in this population.
    Anesthesiology 12/2013; 119(6):1434-43. DOI:10.1097/ALN.0b013e3182a8eb1f · 5.88 Impact Factor
Show more