Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (original) (raw)
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The Journal of bone and joint surgery. British volume, 2012
The ideal bearing surface for young patients undergoing total hip replacement (THR) remains controversial. We report the five-year results of a randomised controlled trial comparing the clinical and radiological outcomes of 102 THRs in 91 patients who were < 65 years of age. These patients were randomised to receive a cobalt-chrome on ultra-high-molecular-weight polyethylene, cobalt-chrome on highly cross-linked polyethylene, or a ceramic-on-ceramic bearing. In all, 97 hip replacements in 87 patients were available for review at five years. Two hips had been revised, one for infection and one for peri-prosthetic fracture. At the final follow-up there were no significant differences between the groups for the mean Western Ontario and McMaster Universities osteoarthritis index (pain, p = 0.543; function, p = 0.10; stiffness, p = 0.99), Short Form-12 (physical component, p = 0.878; mental component, p = 0.818) or Harris hip scores (p = 0.22). Radiological outcomes revealed no signif...
The Bone & Joint Journal, 2011
The aim of this study was to investigate the possible benefit of large-head metal-on-metal bearing on a stem for primary hip replacement compared with a 28 mm diameter conventional metal-on-polyethylene bearing in a prospective randomised controlled trial. We investigated cemented stem behaviour between these two different bearings using Einzel-Bild-Röntgen-Analyse, clinical and patient reported measures (Harris hip score, Western Ontario and McMaster Universities osteoarthritis index, Short Form-36 and satisfaction) and whole blood metal ion levels at two years. A power study indicated that 50 hips were needed in each group to detect subsidence of > 5 mm at two years with a p-value of < 0.05.
Bearing surfaces in hip replacement- Evolution and likely future
Medical Journal Armed Forces India, 2014
Total hip arthroplasty has evolved from the first total hip arthroplasty in 1938, through the revolutionization of hip arthroplasty by principles of low friction arthroplasty introduced by Sir John Charnley in 1960s to the present state of the art implants and techniques. The main concern regarding failure of total hip arthroplasty has been the biological response to particulate polyethylene debris generated by conventional metal on polyethylene bearing surfaces leading to osteolysis and aseptic loosening of the prosthesis. Therefore, recent research has been focussing on alternative bearing surfaces to reduce the particulate debris generated. These bearing surfaces include ceramic-polyethylene, metal-metal as well as ceramic-ceramic articulations and have demonstrated lesser friction rates as well as significantly lower wear rates as compared to widely used metal on polyethylene surfaces. Clinical experience until now has shown that metal on metal articulations have significant safety concerns whereas metal-on-highly crosslinked polyethylene, ceramic on ceramic and ceramic on highly crosslinked polyethylene articulations have shown encouraging results to hold promise for wider use in younger and more active patients. This review article discusses positives and drawbacks of various bearing surfaces in current clinical use in total hip arthroplasty as well as briefly explores the newer technologies on the horizon which may even further decrease wear and improve total hip arthroplasty survivorship.
Outcome analysis of various bearing surface materials used in total hip replacement
Materials Express, 2020
Since the first total hip replacement (THR) in 1938 by Philip Wiles, prosthesis materials and THR surgical technologies have developed rapidly. In this review, we use internationally-published research to synthesize a comprehensive analysis of the specific characteristics and clinical outcomes of different bearing surfaces used in THR. Polyethylene, metallic alloys, and ceramic have become the three most commonly used hip prosthesis bearing surfaces after decades of hip implant development. Different bearing surface types have varying characteristics that offer specific benefits and risks of complication. A thorough understanding of the unique properties and possible complications of each type of bearing surface is critical to surgeons tasked with selecting appropriate implant materials for total hip replacement.
The Journal of bone and joint surgery. American volume, 2014
The regulation of medical devices has attracted controversy recently because of problems related to metal-on-metal hip implants. There is growing evidence that metal-on-metal implants fail early and cause local and systemic complications. However, the failure associated with metal-on-metal head size is not consistently documented and needs to be communicated to patients and surgeons. The purpose of this study is to compare implant survival of metal on metal with that of metal on highly cross-linked polyethylene. Using a distributed health data network, primary total hip arthroplasties were identified from six national and regional total joint arthroplasty registries (2001 to 2010). Inclusion criteria were patient age of forty-five to sixty-four years, cementless total hip arthroplasties, primary osteoarthritis diagnosis, and exclusion of the well-known outlier implant ASR (articular surface replacement). The primary outcome was revision for any reason. A meta-analysis of survival pr...
Metal-on-Metal Total Hip Replacement
Clinical Orthopaedics and Related Research, 2005
Second-generation metal-on-metal (M/M) total hip replacements were introduced into clinical use in the late 1980s and demonstrate equivalent survivorship to conventional metal-on-polyethylene prostheses. Wear rates are comparable to those of first-generation designs that survived for a long time in the body. Biological effects from metal ions remain a concern. Patients with both firstand second-generation M/M hips have higher levels of cobalt and chromium in their blood and urine than either patients with metal-on-polyethylene devices or unoperated patients. Concerns include the potential for acquired hypersensitivity, mutagenicity, and carcinogenicity. However, reports of proven adverse effects are scant. Prospective, randomized trials with follow-up in excess of 15 years will be needed to differentiate between the performance and effects of M/M and other bearing combinations. Key words: total hip arthroplasty, metal-on-metal, wear, biological effects, clinical results. n 2005 Elsevier Inc. All rights reserved. The McKee-Farrar prosthesis was developed from the work of Wiles [2] and McKee [3] with refinement of the neck design by Farrar [4]. The device was cemented in place. The Ring prosthesis employed a hemispherical cup with a long,
Dislocation after total hip replacement in relation to metal-on-metal bearing surfaces
The Journal of bone and joint surgery. British volume, 2003
Metal-on-metal (MOM) is a commonly used bearing notable for its 'suction fit' when lubricated. In this study, we examined the capacity for MOM bearings to protect against dislocation after total hip replacement (THR). We undertook a clinical investigation to compare the rate of dislocation of MOM bearings with those of ceramic-on-polyethylene (COP) bearings and found that one MOM bearing dislocated in a series of 109 hips (0.9%) compared with nine of 145 hips (6.2%) in the COP group (p = 0.02). We also performed an in vitro investigation comparing the peak forces generated during forced separation of the two bearings of the same dimensions at velocities from 1 to 50 cm/s. This revealed that the MOM bearing generated significant resistance to separation at all velocities (maximum mean 24 N), whereas the COP did not (maximum mean 1.9 N, p < 0.001). We conclude that MOM bearings are more stable to dislocation than COP bearings as a result of the interfacial forces provided b...
Hip international : the journal of clinical and experimental research on hip pathology and therapy, 2018
Periprosthetic joint infection (PJI) is a serious complication after total hip arthroplasty (THA) and bearing material's associations to PJI prevalence is largely unknown. The main purposes of this study were to determine if revision for infection varied depending on the type of bearing surface used in primary THA and to study whether patient or implant related factors had an effect on this variation. A total of 177,237 primary THA procedures from the Australian Registry (AOANJRR) were analysed. 3 bearing surfaces were compared. Metal-on-highly cross-linked polyethylene (MoXP) bearing had been used in 95,129 hips, ceramic-on-highly cross-linked polyethylene (CoXP) in 24,269 hips, and ceramic-on-ceramic (CoC) in 57,839 hips. Revision rates for infection were compared between the 3 groups. Both MoXP and CoXP had a higher revision rate for infection compared to CoC hips (hazard ratio [HR] 1.46 (1.25, 1.72), p < 0.001) and HR 1.42 (1.15, 1.75), p = 0.001 respectively). Patients a...